Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)
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Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)

BOOSTRIX
(tetanus toxoid, reduced diphtheria toxoid and accllular pertussis vaccine, adsorbed) Suspension for Intramuscular Injection

DRUG DESCRIPTION

BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens.

Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration.

The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde.

Each antigen is individually adsorbed onto aluminum hydroxide. Each 0.5-mL dose is formulated to contain 5 Lf of tetanus toxoid, 2.5 Lf of diphtheria toxoid, 8 mcg of inactivated PT, 8 mcg of FHA, and 2.5 mcg of pertactin (69 kiloDalton outer membrane protein).

Tetanus and diphtheria toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT and formaldehyde-treated FHA and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice.

Each 0.5-mL dose contains aluminum hydroxide as adjuvant (not more than 0.39 mg aluminum by assay), 4.5 mg of sodium chloride, ≤ 100 mcg of residual formaldehyde, and ≤ 100 mcg of polysorbate 80 (Tween 80).

BOOSTRIX is available in vials and 2 types of prefilled syringes. One type of prefilled syringe has a tip cap which may contain natural rubber latex and a plunger which does not contain latex. The other type has a tip cap and a rubber plunger which contain dry natural latex rubber. The vial stopper does not contain latex. [See HOW SUPPLIED, Storage and Handling.]

What are the possible side effects of this vaccine (Adacel (Tdap), Boostrix (Tdap))?

You should not receive a booster vaccine if you had a life threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell your doctor if the previous shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely...

Read All Potential Side Effects and See Pictures of Boostrix »

What are the precautions when taking tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix)?

Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this medication, tell your doctor or pharmacist your medical history, especially of: nervous system disorders (e.g., seizures, encephalopathy, Guillain-Barre syndrome), current illness/infection, bleeding disorders, immune system disorders (e.g., autoimmune disorders, radiation treatment), vaccination history including previous reactions to any vaccines.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and...

Read All Potential Precautions of Boostrix »

Last reviewed on RxList: 7/21/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

BOOSTRIX® is indicated for active booster immunization against tetanus, diphtheria, and pertussis. BOOSTRIX is approved for use as a single dose in individuals 10 years of age and older.

DOSAGE AND ADMINISTRATION

Preparation for Administration

Shake vigorously to obtain a homogeneous, turbid, white suspension before administration. Do not use if resuspension does not occur with vigorous shaking. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

Dose and Schedule

BOOSTRIX is administered as a single 0.5-mL intramuscular injection into the deltoid muscle of the upper arm.

Do not administer this product intravenously, intradermally, or subcutaneously.

There are no data to support repeat administration of BOOSTRIX.

Five years should elapse between the last dose of the recommended series of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and/or Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Td) vaccine and the administration of BOOSTRIX.

Additional Dosing Information

Primary Series: The use of BOOSTRIX as a primary series or to complete the primary series for diphtheria, tetanus, or pertussis has not been studied.

Wound Management: If tetanus prophylaxis is needed for wound management, BOOSTRIX may be given if no previous dose of any Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) has been administered.

HOW SUPPLIED

Dosage Forms and Strengths

BOOSTRIX is a suspension for injection available in 0.5-mL single-dose vials and prefilled TIP-LOK® syringes.

BOOSTRIX is available in 0.5-mL single-dose vials and disposable prefilled TIP-LOK syringes (packaged without needles):

NDC 58160-842-01 Vial (contains no latex) in Package of 10: NDC 58160-842-11 NDC 58160-842-34 Syringe (tip cap may contain latex; plunger contains no latex) in Package of 1: NDC 58160-842-34

NDC 58160-842-43 Syringe (tip cap may contain latex; plunger contains no latex) in Package of 10: NDC 58160-842-52

NDC 58160-842-41 Syringe (tip cap and plunger contain latex) in Package of 1: NDC 58160-842-32

NDC 58160-842-41 Syringe (tip cap and plunger contain latex) in Package of 5: NDC 58160-842-46

NDC 58160-842-41 Syringe (tip cap and plunger contain latex) in Package of 10: NDC 58160-842-51

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen.

Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium. Revised: July 2011

Last reviewed on RxList: 7/21/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. As with any vaccine, there is the possibility that broad use of BOOSTRIX could reveal adverse reactions not observed in clinical trials.

In clinical studies, 4,949 adolescents (10 to 18 years of age) and 4,076 adults (19 years of age and older) were vaccinated with a single dose of BOOSTRIX. Of these adolescents, 1,341 were vaccinated with BOOSTRIX in a coadministration study with meningococcal conjugate vaccine [see DRUG INTERACTIONS and Clinical Studies]. Of these adults, 1,104 were 65 years of age and older [see Clinical Studies]. A total of 860 adults 19 years of age and older received concomitant vaccination with BOOSTRIX and influenza vaccines in a coadministration study [see DRUG INTERACTIONS and Clinical Studies]. An additional 1,092 adolescents 10 to 18 years of age received a non-US formulation of BOOSTRIX (formulated to contain 0.5 mg aluminum per dose) in non-US clinical studies.

In a randomized, observer-blinded, controlled study in the US, 3,080 adolescents 10 to 18 years of age received a single dose of BOOSTRIX and 1,034 received the comparator Td vaccine, manufactured by MassBioLogics. There were no substantive differences in demographic characteristics between the vaccine groups. Among BOOSTRIX and comparator vaccine recipients, approximately 75% were 10 to 14 years of age and approximately 25% were 15 to 18 years of age. Approximately 98% of participants in this study had received the recommended series of 4 or 5 doses of either Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTwP) or a combination of DTwP and DTaP in childhood. Subjects were monitored for solicited adverse events using standardized diary cards (day 0-14). Unsolicited adverse events were monitored for the 31-day period following vaccination (day 0-30). Subjects were also monitored for 6 months post-vaccination for non-routine medical visits, visits to an emergency room, onset of new chronic illness, and serious adverse events. Information regarding late onset adverse events was obtained via a telephone call 6 months following vaccination. At least 97% of subjects completed the 6-month follow-up evaluation.

In a study conducted in Germany, BOOSTRIX was administered to 319 children 10 to 12 years of age previously vaccinated with 5 doses of acellular pertussis antigen-containing vaccines; 193 of these subjects had previously received 5 doses of INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed). Adverse events were recorded on diary cards during the 15 days following vaccination. Unsolicited adverse events that occurred within 31 days of vaccination (day 0-30) were recorded on the diary card or verbally reported to the investigator. Subjects were monitored for 6 months post-vaccination for physician office visits, emergency room visits, onset of new chronic illness, and serious adverse events. The 6-month follow-up evaluation, conducted via telephone interview, was completed by 90% of subjects.

The US adult (19 to 64 years of age) study, a randomized, observer-blinded study, evaluated the safety of BOOSTRIX (N = 1,522) compared with ADACEL® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) (N = 762), a Tdap vaccine manufactured by Sanofi Pasteur SA. Vaccines were administered as a single dose. There were no substantive differences in demographic characteristics between the vaccine groups. Subjects were monitored for solicited adverse events using standardized diary cards (day 0-14). Unsolicited adverse events were monitored for the 31-day period following vaccination (day 0-30). Subjects were also monitored for 6 months post-vaccination for serious adverse events, visits to an emergency room, hospitalizations, and onset of new chronic illness. Approximately 95% of subjects completed the 6-month follow-up evaluation.

The US elderly (65 years of age and older) study, a randomized, observer-blinded study, evaluated the safety of BOOSTRIX (N = 887) compared with DECAVAC® (Tetanus and Diphtheria Toxoids Adsorbed) (N = 445), a US-licensed Td vaccine, manufactured by Sanofi Pasteur SA. Vaccines were administered as a single dose. Among all vaccine recipients, the mean age was approximately 72 years; 54% were female and 95% were white. Subjects were monitored for solicited adverse events using standardized diary cards (day 0-3). Unsolicited adverse events were monitored for the 31-day period following vaccination (day 0-30). Subjects were also monitored for 6 months post-vaccination for serious adverse events. Approximately 99% of subjects completed the 6-month follow-up evaluation.

Solicited Adverse Events in the US Adolescent Study: Table 1 presents the solicited local adverse reactions and general adverse events within 15 days of vaccination with BOOSTRIX or Td vaccine for the total vaccinated cohort.

The primary safety endpoint was the incidence of grade 3 pain (spontaneously painful and/or prevented normal activity) at the injection site within 15 days of vaccination. Grade 3 pain was reported in 4.6% of those who received BOOSTRIX compared with 4.0% of those who received the Td vaccine. The difference in rate of grade 3 pain was within the pre-defined clinical limit for non-inferiority (upper limit of the 95% CI for the difference [BOOSTRIX minus Td] ≤ 4%).

Table 1. Rates of Solicited Local Adverse Reactions or General Adverse Events Within the 15-daya Post-Vaccination Period in Adolescents 10 to 18 Years of Age (Total Vaccinated Cohort)

  BOOSTRIX
(N = 3,032)
%
Td
(N = 1,013)
%
Local
  Pain, anyb 75.3 71.7
  Pain, grade 2 or 3b 51.2 42.5
  Pain, grade 3c 4.6 4.0
  Redness, any 22.5 19.8
  Redness, > 20 mm 4.1 3.9
  Redness, ≥ 50 mm 1.7 1.6
  Swelling, any 21.1 20.1
  Swelling, > 20 mm 5.3 4.9
  Swelling, ≥ 50 mm 2.5 3.2
  Arm circumference increase, > 5 mmd 28.3 29.5
  Arm circumference increase, > 20 mmd 2.0 2.2
  Arm circumference increase, > 40 mmd 0.5 0.3
General
  Headache, any 43.1 41.5
  Headache, grade 2 or 3b 15.7 12.7
  Headache, grade 3 3.7 2.7
  Fatigue, any 37.0 36.7
  Fatigue, grade 2 or 3 14.4 12.9
  Fatigue, grade 3 3.7 3.2
  Gastrointestinal symptoms, anye 26.0 25.8
  Gastrointestinal symptoms, grade 2 or 3e 9.8 9.7
  Gastrointestinal symptoms, grade 3e 3.0 3.2
  Fever, ≥ 99.5°F (37.5°C)f 13.5 13.1
  Fever, > 100.4°F (38.0°C)f 5.0 4.7
  Fever, > 102.2°F (39.0°C)f 1.4 1.0
Td = Tetanus and Diphtheria Toxoids Adsorbed For Adult Use manufactured by MassBioLogics.
N = Number of subjects in the total vaccinated cohort with local/general symptoms sheets completed.
Grade 2 = Local: painful when limb moved; General: interfered with normal activity.
Grade 3 = Local: spontaneously painful and/or prevented normal activity; General: prevented normal activity.
a Day of vaccination and the next 14 days.
b Statistically significantly higher (P < 0.05) following BOOSTRIX as compared to Td vaccine.
c Grade 3 injection site pain following BOOSTRIX was not inferior to Td vaccine (upper limit of two-sided 95% CI for the difference [BOOSTRIX minus Td] in the percentage of subjects ≤ 4%).
d Mid-upper region of the vaccinated arm.
e Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
f Oral temperatures or axillary temperatures.

Unsolicited Adverse Events in the US Adolescent Study: The incidence of unsolicited adverse events reported in the 31 days after vaccination was comparable between the 2 groups (25.4% and 24.5% for BOOSTRIX and Td vaccine, respectively).

Solicited Adverse Events in the German Adolescent Study: Table 2 presents the rates of solicited local adverse reactions and fever within 15 days of vaccination for those subjects who had previously been vaccinated with 5 doses of INFANRIX. No cases of whole arm swelling were reported. Two individuals (2/193) reported large injection site swelling (range 110 to 200 mm diameter), in one case associated with grade 3 pain. Neither individual sought medical attention. These episodes were reported to resolve without sequelae within 5 days.

Table 2. Rates of Solicited Adverse Events Reported Within the 15-daya Post-Vaccination Period Following Administration of BOOSTRIX in Adolescents 10 to 12 Years of Age Who Had Previously Received 5 Doses of INFANRIX

  BOOSTRIX
(N = 193)
%
Pain, any 62.2
Pain, grade 2 or 3 33.2
Pain, grade 3 5.7
Redness, any 47.7
Redness, > 20 mm 15.0
Redness, ≥ 50 mm 10.9
Swelling, any 38.9
Swelling, > 20 mm 17.6
Swelling, ≥ 50 mm 14.0
Fever, ≥ 99.5°F (37.5°C)b 8.8
Fever, > 100.4°F (38.0°C)b 4.1
Fever, > 102.2°F (39.0°C)b 1.0
N = Number of subjects with local/general symptoms sheets completed.
Grade 2 = Painful when limb moved.
Grade 3 = Spontaneously painful and/or prevented normal activity.
a Day of vaccination and the next 14 days.
b Oral temperatures or axillary temperatures.

Solicited Adverse Events in the US Adult (19 to 64 Years of Age) Study: Table 3 presents solicited local adverse reactions and general adverse events within 15 days of vaccination with BOOSTRIX or the comparator Tdap vaccine for the total vaccinated cohort.

Table 3. Rates of Solicited Local Adverse Reactions or General Adverse Events Within the 15-daya Post-Vaccination Period in Adults 19 to 64 Years of Age (Total Vaccinated Cohort)

  BOOSTRIX
(N = 1,480)
%
Tdap
(N = 741)
%
Local
  Pain, any 61.0 69.2
  Pain, grade 2 or 3 35.1 44.4
  Pain, grade 3 1.6 2.3
  Redness, any 21.1 27.1
  Redness, > 20 mm 4.0 6.2
  Redness, ≥ 50 mm 1.6 2.3
  Swelling, any 17.6 25.6
  Swelling, > 20 mm 3.9 6.3
  Swelling, ≥ 50 mm 1.4 2.8
General
  Headache, any 30.1 31.0
  Headache, grade 2 or 3 11.1 10.5
  Headache, grade 3 2.2 1.5
  Fatigue, any 28.1 28.9
  Fatigue, grade 2 or 3 9.1 9.4
  Fatigue, grade 3 2.5 1.2
  Gastrointestinal symptoms, anyb 15.9 17.5
  Gastrointestinal symptoms, grade 2 or 3b 4.3 5.7
  Gastrointestinal symptoms, grade 3b 1.2 1.3
  Fever, ≥ 99.5°F (37.5°C)c 5.5 8.0
  Fever, > 100.4°F (38.0°C)c 1.0 1.5
  Fever, > 102.2°F (39.0°C)c 0.1 0.4
Tdap = Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed, a Tdap vaccine manufactured by Sanofi Pasteur SA.
N = Number of subjects in the total vaccinated cohort with local/general symptoms sheets completed.
Grade 2 = Local: painful when limb moved; General: interfered with normal activity.
Grade 3 = Local/General: prevented normal activity.
a Day of vaccination and the next 14 days.
b Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
c Oral temperatures.

Unsolicited Adverse Events in the US Adult (19 to 64 Years of Age) Study: The incidence of unsolicited adverse events reported in the 31 days after vaccination was comparable between the 2 groups (17.8% and 22.2% for BOOSTRIX and Tdap vaccine, respectively).

Solicited Adverse Events in the US Elderly (65 Years of Age and Older) Study: Table 4 presents solicited local adverse reactions and general adverse events within 4 days of vaccination with BOOSTRIX or the comparator Td vaccine for the total vaccinated cohort.

Table 4. Rates of Solicited Local Adverse Reactions or General Adverse Events Within 4 Daysa of Vaccination in the Elderly 65 Years of Age and Older (Total Vaccinated Cohort)

  BOOSTRIX
%
Td
%
Local (N = 882) (N = 444)
  Pain, any 21.5 27.7
  Pain, grade 2 or 3 7.5 10.1
  Pain, grade 3 0.2 0.7
  Redness, any 10.8 12.6
  Redness, > 20 mm 1.4 2.5
  Redness, ≥ 50 mm 0.6 0.9
  Swelling, any 7.5 11.7
  Swelling, > 20 mm 2.2 3.4
  Swelling, ≥ 50 mm 0.7 0.7
General (N = 882) (N = 445)
  Fatigue, any 12.5 14.8
  Fatigue, grade 2 or 3 2.5 2.9
  Fatigue, grade 3 0.7 0.7
  Headache, any 11.5 11.7
  Headache, grade 2 or 3 1.9 2.2
  Headache, grade 3 0.6 0.0
  Gastrointestinal symptoms, anyb 7.6 9.2
  Gastrointestinal symptoms, grade 2 or 3b 1.7 1.8
  Gastrointestinal symptoms, grade 3b 0.3 0.4
  Fever, ≥ 99.5°F (37.5°C)c 2.0 2.5
  Fever, > 100.4°F (38.0°C)c 0.2 0.2
  Fever, > 102.2°F (39.0°C)c 0.0 0.0
Td = Tetanus and Diphtheria Toxoids Adsorbed, a US-licensed Td vaccine, manufactured by Sanofi Pasteur SA.
N = Number of subjects with a documented dose.
Grade 2 = Local: painful when limb moved; General: interfered with normal activity.
Grade 3 = Local/General: prevented normal activity.
a Day of vaccination and the next 3 days.
b Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
c Oral temperatures.

Unsolicited Adverse Events in the US Elderly (65 Years of Age and Older) Study: The incidence of unsolicited adverse events reported in the 31 days after vaccination was comparable between the 2 groups (17.1% and 14.4% for BOOSTRIX and Td vaccine, respectively).

Serious Adverse Events (SAEs): In the US and German adolescent safety studies, no serious adverse events were reported to occur within 31 days of vaccination. During the 6-month extended safety evaluation period, no serious adverse events that were of potential autoimmune origin or new onset and chronic in nature were reported to occur. In non-US adolescent studies in which serious adverse events were monitored for up to 37 days, one subject was diagnosed with insulin-dependent diabetes 20 days following administration of BOOSTRIX. No other serious adverse events of potential autoimmune origin or that were new onset and chronic in nature were reported to occur in these studies. In the US adult (19 to 64 years of age) study, serious adverse events were reported to occur during the entire study period (0-6 months) by 1.4% and 1.7% of subjects who received BOOSTRIX and the comparator Tdap vaccine, respectively. During the 6-month extended safety evaluation period, no serious adverse events of a neuroinflammatory nature or with information suggesting an autoimmune etiology were reported in subjects who received BOOSTRIX. In the US elderly (65 years of age and older) study, serious adverse events were reported to occur by 0.7% and 0.9% of subjects who received BOOSTRIX and the comparator Td vaccine, respectively, during the 31-day period after vaccination. Serious adverse events were reported to occur by 4.2% and 2.2% of subjects who received BOOSTRIX and the comparator Td vaccine, respectively, during the 6-month period after vaccination.

Concomitant Vaccination With Meningococcal Conjugate Vaccine in Adolescents: In a randomized study in the US, 1,341 adolescents (11 to 18 years of age) received either BOOSTRIX administered concomitantly with MENACTRA® (Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine), (Sanofi Pasteur SA), or each vaccine administered separately 1 month apart [see DRUG INTERACTIONS and Clinical Studies]. Safety was evaluated in 446 subjects who received BOOSTRIX administered concomitantly with meningococcal conjugate vaccine at different injection sites, 446 subjects who received BOOSTRIX followed by meningococcal conjugate vaccine 1 month later, and 449 subjects who received meningococcal conjugate vaccine followed by BOOSTRIX 1 month later. Solicited local adverse reactions and general adverse events were recorded on diary cards for 4 days (day 0-3) following each vaccination. Unsolicited adverse events were monitored for the 31-day period following each vaccination (day 0-30). Table 5 presents the percentages of subjects experiencing local reactions at the injection site for BOOSTRIX and solicited general events following BOOSTRIX. The incidence of unsolicited adverse events reported in the 31 days after any vaccination was similar following each dose of BOOSTRIX in all cohorts.

Table 5. Rates of Solicited Local Adverse Reactions or General Adverse Events Reported Within the 4-day Post-Vaccination Period following Administration of BOOSTRIX in Individuals 11 to 18 Years of Age (Total Vaccinated Cohort)

  BOOSTRIX+ MCV4a
(N = 441)
%
BOOSTRIX→ MCV4b
(N = 432-433)
%
MCV4→ BOOSTRIXc
(N = 441)
%
Local (at injection site for BOOSTRIX)
  Pain, any 70.1 70.4 47.8
  Redness, any 22.7 25.7 17.9
  Swelling, any 17.7 18.1 12.0
General (following administration of BOOSTRIX)
  Fatigue 34.0 32.1 20.4
  Headache 34.0 30.7 17.0
  Gastrointestinal symptomsd 15.2 14.5 7.7
  Fever, ≥ 99.5°F (37.5°C)e 5.2 3.5 2.3
MCV4 = MENACTRA (Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine), Sanofi Pasteur SA.
N = number of subjects in the total vaccinated cohort with local/general symptoms sheets completed.
a BOOSTRIX+MCV4 = concomitant vaccination with BOOSTRIX and MENACTRA.
b BOOSTRIX→MCV4 = BOOSTRIX followed by MCV4 1 month later.
c MCV4→BOOSTRIX = MCV4 followed by BOOSTRIX 1 month later.
d Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
e Oral temperatures.

Postmarketing Experience

In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for BOOSTRIX in persons 10 years of age and older since market introduction of this vaccine are listed below. This list includes serious events or events which have causal connection to components of this or other vaccines or drugs. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to the vaccine.

Blood and Lymphatic System Disorders: Lymphadenitis, lymphadenopathy.

Cardiac Disorders: Myocarditis.

General Disorders and Administration Site Conditions: Extensive swelling of the injected limb, injection site induration, injection site inflammation, injection site mass, injection site pruritus, injection site nodule, injection site warmth, local reaction.

Musculoskeletal and Connective Tissue Disorders: Arthralgia, back pain, myalgia.

Nervous System Disorders: Convulsion, encephalitis, facial palsy, paraesthesia. Skin and Subcutaneous Tissue Disorders: Exanthem, Henoch-Schonlein purpura, rash, urticaria.

Read the Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Concomitant Vaccine Administration

BOOSTRIX was administered concomitantly with MENACTRA in a clinical study of subjects 11 to 18 years of age [see Clinical Studies]. Post-vaccination geometric mean antibody concentrations (GMCs) to pertactin were lower following BOOSTRIX administered concomitantly with meningococcal conjugate vaccine compared to BOOSTRIX administered first. It is not known if the efficacy of BOOSTRIX is affected by the reduced response to pertactin.

BOOSTRIX was administered concomitantly with FLUARIX® (Influenza Virus Vaccine) in a clinical study of subjects 19 to 64 years of age [see Clinical Studies]. Lower GMCs for antibodies to the pertussis antigens filamentous hemagglutinin (FHA) and pertactin were observed when BOOSTRIX was administered concomitantly with FLUARIX as compared with BOOSTRIX alone. It is not known if the efficacy of BOOSTRIX is affected by the reduced response to FHA and pertactin.

When BOOSTRIX is administered concomitantly with other injectable vaccines or Tetanus Immune Globulin, they should be given with separate syringes and at different injection sites. BOOSTRIX should not be mixed with any other vaccine in the same syringe or vial.

Immunosuppressive Therapies

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to BOOSTRIX.

Last reviewed on RxList: 7/21/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Latex

BOOSTRIX is available in vials and 2 types of prefilled syringes. One type of prefilled syringe has a tip cap which may contain natural rubber latex and a plunger which does not contain latex. The other type has a tip cap and a rubber plunger which contain dry natural latex rubber. Use of these syringes may cause allergic reactions in latex-sensitive individuals. The vial stopper does not contain latex. [See HOW SUPLIED, Storage and Handling.]

Guillain-Barre Syndrome and Brachial Neuritis

If Guillain-Barre syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk of Guillain-Barre syndrome may be increased following a subsequent dose of tetanus toxoid-containing vaccine, including BOOSTRIX. A review by the Institute of Medicine (IOM) found evidence for a causal relationship between receipt of tetanus toxoid and both brachial neuritis and Guillain-Barre syndrome.1

Progressive or Unstable Neurologic Disorders

Progressive or unstable neurologic conditions (e.g., cerebrovascular events and acute encephalopathic conditions) are reasons to defer vaccination with a pertussis-containing vaccine, including BOOSTRIX. It is not known whether administration of BOOSTRIX to persons with an unstable or progressive neurologic disorder might hasten manifestations of the disorder or affect the prognosis. Administration of BOOSTRIX to persons with an unstable or progressive neurologic disorder may result in diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination.

Arthus-Type Hypersensitivity

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have a high serum tetanus antitoxin level and should not receive BOOSTRIX or other tetanus toxoid-containing vaccines unless at least 10 years have elapsed since the last dose of tetanus toxoid-containing vaccine.

Altered Immunocompetence

As with any vaccine, if administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained.

Prevention and Management of Acute Allergic Reactions

Prior to administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

BOOSTRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with BOOSTRIX. It is also not known whether BOOSTRIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. BOOSTRIX should be given to a pregnant woman only if clearly needed.

Animal fertility studies have not been conducted with BOOSTRIX. In a developmental toxicity study, the effect of BOOSTRIX on embryo-fetal and pre-weaning development was evaluated in pregnant rats. Animals were administered INFANRIX prior to gestation and BOOSTRIX during the period of organogenesis (gestation days 6, 8, 11) and later in pregnancy (gestation day 15), 0.1 mL/rat/occasion (a 45-fold increase compared with the human dose of BOOSTRIX on a body weight basis), by intramuscular injection. No adverse effect on pregnancy and lactation parameters, embryo-fetal or pre-weaning development was observed. There were no fetal malformations or other evidence of teratogenesis noted in this study.

Pregnancy Registry: GlaxoSmithKline maintains a surveillance registry to collect data on pregnancy outcomes and newborn health status outcomes following vaccination with BOOSTRIX during pregnancy. Women who receive BOOSTRIX during pregnancy should be encouraged to contact GlaxoSmithKline directly or their healthcare provider should contact GlaxoSmithKline by calling 1-888-452-9622.

Nursing Mothers

It is not known whether BOOSTRIX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BOOSTRIX is administered to a nursing woman.

Pediatric Use

BOOSTRIX is not indicated for use in children younger than 10 years of age. Safety and effectiveness of BOOSTRIX in this age group have not been established.

Geriatric Use

In clinical trials, 1,104 subjects 65 years of age and older received BOOSTRIX; of these subjects, 299 were 75 years of age and older. In the US elderly (65 years and older) study, immune responses to tetanus and diphtheria toxoids following BOOSTRIX were non-inferior to the comparator Td vaccine. Antibody responses to pertussis antigens following a single dose of BOOSTRIX in the elderly were non-inferior to those observed with INFANRIX administered as a 3-dose series in infants [see Clinical Studies]. Solicited adverse events following BOOSTRIX were similar in frequency to those reported with the comparator Td vaccine [see ADVERSE REACTIONS].

Last reviewed on RxList: 7/21/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

Hypersensitivity

A severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine or any component of this vaccine is a contraindication to administration of BOOSTRIX [see DESCRIPTION]. Because of the uncertainty as to which component of the vaccine might be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is considered.

Encephalopathy

Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis antigen-containing vaccine, including BOOSTRIX.

Last reviewed on RxList: 7/21/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Tetanus: Tetanus is a condition manifested primarily by neuromuscular dysfunction caused by a potent exotoxin released by C. tetani. Protection against disease is due to the development of neutralizing antibodies to the tetanus toxin. A serum tetanus antitoxin level of at least 0.01 lU/mL, measured by neutralization assays, is considered the minimum protective level.2 A level ≥ 0.1 IU/mL by ELISA has been considered as protective.

Diphtheria: Diphtheria is an acute toxin-mediated infectious disease caused by toxigenic strains of C. diphtheriae. Protection against disease is due to the development of neutralizing antibodies to the diphtheria toxin. A serum diphtheria antitoxin level of 0.01 IU/mL, measured by neutralization assays, is the lowest level giving some degree of protection; a level of 0.1 IU/mL by ELISA is regarded as protective.3 Diphtheria antitoxin levels ≥ 1.0 IU/mL by ELISA have been associated with long-term protection.3

Pertussis: Pertussis (whooping cough) is a disease of the respiratory tract caused by B. pertussis. The role of the different components produced by B. pertussis in either the pathogenesis of, or the immunity to, pertussis is not well understood.

Clinical Studies

The efficacy of the tetanus and diphtheria toxoid components of BOOSTRIX is based on the immunogenicity of the individual antigens compared to US-licensed vaccines using established serologic correlates of protection. The efficacy of the pertussis components of BOOSTRIX was evaluated by comparison of the immune response of adolescents and adults following a single dose of BOOSTRIX to the immune response of infants following a 3-dose primary series of INFANRIX. In addition, the ability of BOOSTRIX to induce a booster response to each of the antigens was evaluated.

Efficacy of INFANRIX

The efficacy of a 3-dose primary series of INFANRIX in infants has been assessed in 2 clinical studies: A prospective efficacy trial conducted in Germany employing a household contact study design and a double-blind, randomized, active Diphtheria and Tetanus Toxoids (DT)-controlled trial conducted in Italy sponsored by the National Institutes of Health (NIH) (for details see INFANRIX prescribing information). Serological data from a subset of infants immunized with INFANRIX in the household contact study were compared with the sera of adolescents and adults immunized with BOOSTRIX [see Clinical Studies]. In the household contact study, the protective efficacy of INFANRIX, in infants, against WHO-defined pertussis (21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing) was calculated to be 89% (95% CI: 77%, 95%). When the definition of pertussis was expanded to include clinically milder disease, with infection confirmed by culture and/or serologic testing, the efficacy of INFANRIX against ≥ 7 days of any cough was 67% (95% CI: 52%, 78%) and against ≥ 7 days of paroxysmal cough was 81% (95% CI: 68%, 89%) (for details see INFANRIX prescribing information).

Immune-logical Evaluation in Adolescents

In a multicenter, randomized, controlled study conducted in the United States, the immune responses to each of the antigens contained in BOOSTRIX were evaluated in sera obtained approximately 1 month after administration of a single dose of vaccine to adolescent subjects (10 to 18 years of age). Of the subjects enrolled in this study, approximately 76% were 10 to 14 years of age and 24% were 15 to 18 years of age. Approximately 98% of participants in this study had received the recommended series of 4 or 5 doses of either DTwP or a combination of DTwP and DTaP in childhood. The racial/ethnic demographics were as follows: white 85.8%, black 5.7%, Hispanic 5.6%, Oriental 0.8%, and other 2.1%.

Response to Tetanus and Diphtheria Toxoids: The antibody responses to the tetanus and diphtheria toxoids of BOOSTRIX compared with Td vaccine are shown in Table 6. One month after a single dose, anti-tetanus and anti-diphtheria seroprotective rates ( ≥ 0.1 IU/mL by ELISA) and booster response rates were comparable between BOOSTRIX and the comparator Td vaccine.

Table 6. Antibody Responses to Tetanus and Diphtheria Toxoids Following BOOSTRIX Compared With Td Vaccine in Adolescents 10 to 18 Years of Age (ATP Cohort for Immunogenicity)

  N % ≥ 0.1 IU/mLa
(95% CI)
% ≥ 1.0 IU/mLa
(95% CI)
% Booster Responseb
(95% CI)
Anti-Tetanus
BOOSTRIX 2,469-2,516      
  Pre-vaccination   97.7 (97.1,98.3) 36.8 (34.9, 38.7) -
  Post-vaccination   100 (99.8, 100)c 99.5 (99.1,99.7)d 89.7 (88.4, 90.8)c
Td 817-834      
  Pre-vaccination   96.8 (95.4, 97.9) 39.9 (36.5, 43.4) -
  Post-vaccination   100 (99.6, 100) 99.8 (99.1, 100) 92.5 (90.5, 94.2)
Anti-Diphtheria
BOOSTRIX 2,463-2,515      
  Pre-vaccination   85.8 (84.3, 87.1) 17.1 (15.6, 18.6) -
  Post-vaccination   99.9 (99.7, 100)c 97.3 (96.6, 97.9)d 90.6 (89.4, 91. 7)c
Td 814-834      
  Pre-vaccination   84.8 (82.1,87.2) 19.5 (16.9, 22.4) -
  Post-vaccination   99.9 (99.3, 100) 99.3 (98.4, 99.7) 95.9 (94.4, 97.2)
Td manufactured by MassBioLogics.
ATP = according-to-protocol; CI = Confidence Interval.
a Measured by ELISA.
b Booster response: In subjects with pre-vaccination < 0.1 IU/mL, post-vaccination concentration ≥ 0.4 IU/mL. In subjects with pre-vaccination concentration ≥ 0.1 IU/mL, an increase of at least 4 times the pre-vaccination concentration.
c Seroprotection rate or booster response rate to BOOSTRIX was non-inferior to Td (upper limit of two-sided 95% CI on the difference for Td minus BOOSTRIX ≤ 10%).
d Non-inferiority criteria not prospectively defined for this endpoint.

Response to Pertussis Antigens: The booster response rates of adolescents to the pertussis antigens are shown in Table 7. For each of the pertussis antigens the lower limit of the two-sided 95% CI for the percentage of subjects with a booster response exceeded the predefined lower limit of 80% for demonstration of an acceptable booster response.

Table 7. Booster Responses to the Pertussis Antigens Following BOOSTRIX in Adolescents 10 to 18 Years of Age (ATP Cohort for Immunogenicity)

  N BOOSTRIX
% Booster Responsea (95% CI)
Anti-PT 2,677 84.5 (83.0, 85.9)
Anti-FHA 2,744 95.1 (94.2, 95.9)
Anti-pertactin 2,752 95.4 (94.5, 96.1)
ATP = according-to-protocol; CI = Confidence Interval.
a Booster response: In initially seronegative subjects ( < 5 EL.U./mL), post-vaccination antibody concentrations ≥ 20 EL.U./mL. In initially seropositive subjects with pre-vaccination antibody concentrations ≥ 5 EL.U./mL and < 20 EL.U./mL, an increase of at least 4 times the pre-vaccination antibody concentration. In initially seropositive subjects with pre-vaccination antibody concentrations ≥ 20 EL.U./mL, an increase of at least 2 times the pre-vaccination antibody concentration.

The GMCs to each of the pertussis antigens 1 month following a single dose of BOOSTRIX in the US adolescent study (N = 2,941-2,979) were compared with the GMCs observed in infants following a 3-dose primary series of INFANRIX administered at 3, 4, and 5 months of age (N = 631-2,884). Table 8 presents the results for the total immunogenicity cohort in both studies (vaccinated subjects with serology data available for at least one pertussis antigen; the majority of subjects in the study of INFANRIX had anti-PT serology data only). These infants were a subset of those who formed the cohort for the German household contact study in which the efficacy of INFANRIX was demonstrated [see Clinical Studies]. Although a serologic correlate of protection for pertussis has not been established, anti-PT, anti-FHA, and anti-pertactin antibody concentrations observed in adolescents 1 month after a single dose of BOOSTRIX were non-inferior to those observed in infants following a primary vaccination series with INFANRIX.

Table 8. Ratio of GMCs to Pertussis Antigens Following One Dose of BOOSTRIX in Adolescents 10 to 18 Years of Age Compared With 3 Doses of INFANRIX in Infants (Total Immunogenicity Cohort)

  CMC Ratio: BOOSTRIX/INFANRIX
(95% CI)
Anti-PT 1.90(1.82, 1.99)a
Anti-FHA 7.35 (6.85, 7.89)a
Anti-pertactin 4.19 (3.73, 4.71)a
GMC = geometric mean antibody concentration, measured in ELISA units; CI = Confidence Interval.
Number of subjects for BOOSTRIX GMC evaluation: Anti-PT = 2,941, anti-FHA = 2,979, and anti-pertactin = 2,978.
Number of subjects for INFANRIX GMC evaluation: Anti-PT = 2,884, anti-FHA = 685, and anti-pertactin = 631.
a GMC following BOOSTRIX was non-inferior to GMC following INFANRIX (lower limit of 95% CI for the GMC ratio of BOOSTRIX/INFANRIX > 0.67).

Immunological Evaluation in Adults (19 to 64 Years of Age)

A multicenter, randomized, observer-blinded study, conducted in the United States, evaluated the immunogenicity of BOOSTRIX compared with the licensed comparator Tdap vaccine (Sanofi Pasteur SA). Vaccines were administered as a single dose to subjects (N = 2,284) who had not received a tetanus-diphtheria booster within 5 years. The immune responses to each of the antigens contained in BOOSTRIX were evaluated in sera obtained approximately 1 month after administration. Approximately 33% of patients were 19 to 29 years of age, 33% were 30 to 49 years of age and 34% were 50 to 64 years of age. Among subjects in the combined vaccine groups, 62% were female; 84% of subjects were white, 8% black, 1% Asian, and 7% were of other racial/ethnic groups.

Response to Tetanus and Diphtheria Toxoids: The antibody responses to the tetanus and diphtheria toxoids of BOOSTRIX compared with the comparator Tdap vaccine are shown in Table 9. One month after a single dose, anti-tetanus and anti-diphtheria seroprotective rates ( ≥ 0.1 IU/mL by ELISA) were comparable between BOOSTRIX and the comparator Tdap vaccine.

Table 9. Antibody Responses to Tetanus and Diphtheria Toxoids Following One Dose of BOOSTRIX Compared With the Comparator Tdap Vaccine in Adults 19 to 64 Years of Age (ATP Cohort for Immunogenicity)

  N % ≥ 0.1 IU/mLa
(95% CI)
% ≥ 1.0 IU/mLa
(95% CI)
Anti-Tetanus
BOOSTRIX 1,445-1,447    
  Pre-vaccination   95.9 (94.8, 96.9) 71.9(69.5,74.2)
  Post-vaccination   99.6 (99.1, 99.8)b 98.3 (97.5, 98.9)b
Tdap 727-728    
  Pre-vaccination   97.2 (95.8, 98.3) 74.7(71.4,77.8)
  Post-vaccination   100 (95.5, 100) 99.3 (98.4, 99.8)
Anti-Diphtheria
BOOSTRIX 1,440-1,444    
  Pre-vaccination   85.2 (83.3, 87.0) 23.7(21.5,26.0)
  Post-vaccination   98.2 (97.4, 98.8)b 87.9 (86.1, 89.5)c
Tdap 720-727    
  Pre-vaccination   89.2(86.7,91.3) 26.5 (23.3, 29.9)
  Post-vaccination   98.6 (97.5, 99.3) 92.0 (89.8, 93.9)
Tdap = Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed manufactured by Sanofi Pasteur SA.
ATP = according-to-protocol; CI = Confidence Interval.
a Measured by ELISA.
b Seroprotection rates for BOOSTRIX were non-inferior to the comparator Tdap vaccine (lower limit of 95% CI on the difference of BOOSTRIX minus Tdap ≥ -10%).
c Non-inferiority criteria not prospectively defined for this endpoint.

Response to Pertussis Antigens: Booster response rates to the pertussis antigens are shown in Table 10. For the FHA and pertactin antigens, the lower limit of the 95% CI for the booster responses exceeded the pre-defined limit of 80% demonstrating an acceptable booster response following BOOSTRIX. The PT antigen booster response lower limit of the 95% CI (74.9%) did not exceed the pre-defined limit of 80%.

Table 10. Booster Responses to the Pertussis Antigens Following One Dose of BOOSTRIX in Adults 19 to 64 Years of Age (ATP Cohort for Immunogenicity)

  N BOOSTRIX
% Booster Responsea
(95% CI)
Anti-PT 1,419 77.2 (74.9, 79.3)b
Anti-FHA 1,433 96.9 (95.8, 97.7)c
Anti-pertactin 1,441 93.2(91.8,94.4)c
ATP = according-to-protocol; CI = Confidence Interval.
a Booster response: In initially seronegative subjects ( < 5 EL.U./mL), post-vaccination antibody concentrations ≥ 20 EL.U./mL. In initially seropositive subjects with pre-vaccination antibody concentrations ≥ 5 EL.U./mL and < 20 EL.U./mL, an increase of at least 4 times the pre-vaccination antibody concentration. In initially seropositive subjects with pre-vaccination antibody concentrations ≥ 20 EL.U./mL, an increase of at least 2 times the pre-vaccination antibody concentration.
b The PT antigen booster response lower limit of the 95% CI did not exceed the pre-defined limit of 80%.
c The FHA and pertactin antigens booster response lower limit of the 95% CI exceeded the predefined limit of 80%.

The GMCs to each of the pertussis antigens 1 month following a single dose of BOOSTRIX in the US adult (19 to 64 years of age) study were compared with the GMCs observed in infants following a 3-dose primary series of INFANRIX administered at 3, 4, and 5 months of age. Table 11 presents the results for the total immunogenicity cohort in both studies (vaccinated subjects with serology data available for at least one pertussis antigen). These infants were a subset of those who formed the cohort for the German household contact study in which the efficacy of INFANRIX was demonstrated [see Clinical Studies]. Although a serologic correlate of protection for pertussis has not been established, anti-PT, anti-FHA, and anti-pertactin antibody concentrations observed in adults 1 month after a single dose of BOOSTRIX were non-inferior to those observed in infants following a primary vaccination series with INFANRIX.

Table 11. Ratio of GMCs to Pertussis Antigens Following One Dose of BOOSTRIX in Adults 19 to 64 Years of Age Compared With 3 Doses of INFANRIX in Infants (Total Immunogenicity Cohort)

  CMC Ratio: BOOSTRIX/INFANRIX
(95% CI)
Anti-PT 1.39(1.32, 1.47)a
Anti-FHA 7.46 (6.86, 8.12)a
Anti-pertactin 3.56(3.10,4.08)a
GMC = geometric mean antibody concentration; CI = Confidence Interval.
Number of subjects for BOOSTRIX GMC evaluation: Anti-PT = 1,460, anti-FHA = 1,472, and anti-pertactin = 1,473.
Number of subjects for INFANRIX GMC evaluation: Anti-PT = 2,884, anti-FHA = 685, and anti-pertactin = 631.
a BOOSTRIX was non-inferior to INFANRIX (lower limit of 95% CI for the GMC ratio of BOOSTRIX/INFANRIX ≥ 0.67).

Immunological Evaluation in the Elderly (65 Years of Age and Older)

The US elderly (65 years of age and older) study, a randomized, observer-blinded study, evaluated the immunogenicity of BOOSTRIX (N = 887) compared with a US-licensed comparator Td vaccine (N = 445) (Sanofi Pasteur SA). Vaccines were administered as a single dose to subjects who had not received a tetanus-diphtheria booster within 5 years. Among all vaccine recipients, the mean age was approximately 72 years of age; 54% were female and 95% were white. The immune responses to each of the antigens contained in BOOSTRIX were evaluated in sera obtained approximately 1 month after administration.

Response to Tetanus and Diphtheria Toxoids and Pertussis Antigens: Immune responses to tetanus and diphtheria toxoids and pertussis antigens were measured 1 month after administration of a single dose of BOOSTRIX or a comparator Td vaccine. Anti-tetanus and anti-diphtheria seroprotective rates ( ≥ 0.1 IU/mL) were comparable between BOOSTRIX and the comparator Td vaccine (Table 12).

Table 12. Immune Responses to Tetanus and Diphtheria Toxoids Following BOOSTRIX or Comparator Td Vaccine in the Elderly 65 Years of Age and Older (ATP Cohort for Immunogenicity)

  BOOSTRIX
(N = 844-864)
Td
(N = 430-439)
Anti-T
  % ≥ 0.1IU/mL(95%CI) 96.8 (95.4, 97.8)a 97.5 (95.6, 98.7)
  % ≥ 1.0IU/mL(95%CI) 88.8 (86.5, 90.8)a 90.0 (86.8, 92.6)
Anti-D
  % ≥ 0.1IU/mL(95%CI) 84.9 (82.3, 87.2)a 86.6 (83.0, 89.6)
  % ≥ 1.0IU/mL(95%CI) 52.0 (48.6, 55.4)b 51.2(46.3,56.0)
Td = Tetanus and Diphtheria Toxoids Adsorbed, a US-licensed Td vaccine, manufactured by Sanofi Pasteur SA.
ATP = according-to-protocol; CI = Confidence Interval.
a Seroprotection rates for BOOSTRIX were non-inferior to the comparator Td vaccine (lower limit of 95% CI on the difference of BOOSTRIX minus Td ≥ -10%).
b Non-inferiority criteria not prospectively defined for this endpoint.

The GMCs to each of the pertussis antigens 1 month following a single dose of BOOSTRIX were compared with the GMCs of infants following a 3-dose primary series of INFANRIX administered at 3, 4, and 5 months of age. Table 13 presents the results for the total immunogenicity cohort in both studies (vaccinated subjects with serology data available for at least one pertussis antigen). These infants were a subset of those who formed the cohort for the German household contact study in which the efficacy of INFANRIX was demonstrated [see Clinical Studies]. Although a serologic correlate of protection for pertussis has not been established, anti-PT, anti-FHA, and anti-pertactin antibody concentrations in the elderly (65 years of age and older) 1 month after a single dose of BOOSTRIX were non-inferior to those of infants following a primary vaccination series with INFANRIX.

Table 13. Ratio of GMCs to Pertussis Antigens Following One Dose of BOOSTRIX in the Elderly 65 Years of Age and Older Compared With 3 Doses of INFANRIX in Infants (Total Immunogenicity Cohort)

  CMC Ratio: BOOSTRIX/INFANRIX(95% CI)
Anti-PT 1.07(1.00, 1.1 5)a
Anti-FHA 8.24 (7.45, 9.12)a
Anti-pertactin 0.93 (0.79, 1.1 0)a
GMC = geometric mean antibody concentration; CI = Confidence Interval.
Number of subjects for BOOSTRIX GMC evaluation: Anti-PT = 865, anti-FHA = 847, and anti- pertactin = 878.
Number of subjects for INFANRIX GMC evaluation: Anti-PT = 2,884, anti-FHA = 685, and anti-pertactin = 631.
a BOOSTRIX was non-inferior to INFANRIX (lower limit of 95% CI for the GMC ratio of BOOSTRIX/INFANRIX ≥ 0.67).

Concomitant Vaccine Administration

Concomitant Administration With Meningococcal Conjugate Vaccine: The concomitant use of BOOSTRIX and a tetravalent meningococcal (groups A, C, Y, and W-135) conjugate vaccine (Sanofi Pasteur SA) was evaluated in a randomized study in healthy adolescents 11 to 18 years of age. A total of 1,341 adolescents were vaccinated with BOOSTRIX. Of these, 446 subjects received BOOSTRIX administered concomitantly with meningococcal conjugate vaccine at different injection sites, 446 subjects received BOOSTRIX followed by meningococcal conjugate vaccine 1 month later, and 449 subjects received meningococcal conjugate vaccine followed by BOOSTRIX 1 month later.

Immune responses to diphtheria and tetanus toxoids (% of subjects with anti-tetanus and anti-diphtheria antibodies ≥ 1.0 lU/mL by ELISA), pertussis antigens (booster responses and GMCs), and meningococcal antigens (vaccine responses) were measured 1 month (range 30 to 48 days) after concomitant or separate administration of BOOSTRIX and meningococcal conjugate vaccine. For BOOSTRIX given concomitantly with meningococcal conjugate vaccine compared to BOOSTRIX administered first, non-inferiority was demonstrated for all antigens, with the exception of the anti-pertactin GMC. The lower limit of the 95% CI for the GMC ratio was 0.54 for anti-pertactin (pre-specified limit ≥ 0.67). For the anti-pertactin booster response, non-inferiority was demonstrated. It is not known if the efficacy of BOOSTRIX is affected by the reduced response to pertactin.

There was no evidence that BOOSTRIX interfered with the antibody responses to the meningococcal antigens when measured by serum bactericidal assays (rSBA) when given concomitantly or sequentially (meningococcal conjugate vaccine followed by BOOSTRIX or BOOSTRIX followed by meningococcal conjugate vaccine.

Concomitant Administration With FLUARIX (Influenza Virus Vaccine): The concomitant use of BOOSTRIX and FLUARIX was evaluated in a multicenter, open-label, randomized, controlled study of 1,497 adults 19 to 64 years of age. In one group, subjects received BOOSTRIX and FLUARIX concurrently (n = 748). The other group received FLUARIX at the first visit, then 1 month later received BOOSTRIX (n = 749). Sera was obtained prior to and 1 month following concomitant or separate administration of BOOSTRIX and/or FLUARIX, as well as 1 month after the separate administration of FLUARIX.

Immune responses following concurrent administration of BOOSTRIX and FLUARIX were non-inferior to separate administration for diphtheria (seroprotection defined as ≥ 0.1 IU/mL), tetanus (seroprotection defined as ≥ 0.1 IU/mL and based on concentrations ≥ 1.0 IU/mL), pertussis toxin (PT) antigen (anti-PT GMC) and influenza antigens (percent of subjects with hemagglutination-inhibition [HI] antibody titer ≥ 1:40 and ≥ 4-fold rise in HI titer). Non-inferiority criteria were not met for the anti-pertussis antigens FHA and pertactin. The lower limit of the 95% CI of the GMC ratio was 0.64 for anti-FHA and 0.60 for anti-pertactin and the pre-specified limit was ≥ 0.67. It is not known if the efficacy of BOOSTRIX is affected by the reduced response to FHA and pertactin.

REFERENCES

1. Institute of Medicine (IOM). Stratton KR, Howe CJ, Johnston RB, eds. Adverse events associated with childhood vaccines. Evidence bearing on causality. Washington, DC: National Academy Press; 1994.

2. Wassilak SGF, Roper MH, Kretsinger K, and Orenstein WA. Tetanus Toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, eds. Vaccines. 5th ed. Saunders; 2008:805-839.

3. Vitek CR and Wharton M. Diphtheria Toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, eds. Vaccines. 5th ed. Saunders; 2008:139-156.

Last reviewed on RxList: 7/21/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

The patient, parent, or guardian should be:

  • informed of the potential benefits and risks of immunization with BOOSTRIX (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) .
  • informed about the potential for adverse reactions that have been temporally associated with administration of BOOSTRIX (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) or other vaccines containing similar components.
  • instructed to report any adverse events to their healthcare provider.
  • given the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/nip).

Last reviewed on RxList: 7/21/2011
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

The patient, parent, or guardian should be:

  • informed of the potential benefits and risks of immunization with BOOSTRIX (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) .
  • informed about the potential for adverse reactions that have been temporally associated with administration of BOOSTRIX (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) or other vaccines containing similar components.
  • instructed to report any adverse events to their healthcare provider.
  • given the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/nip).

Last reviewed on RxList: 7/21/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Boostrix Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DIPHTHERIA/TETANUS/ACELLULAR PERTUSSIS VACCINE - INJECTION

(dip-THEER-ee-uh/TET-un-us/per-TUSS-iss)

COMMON BRAND NAME(S): Adacel, Boostrix

USES: This medication is given to keep up protection (immunity) against diphtheria, tetanus (lockjaw) and pertussis (whooping cough) in children and adults who have been vaccinated for these diseases in the past. Vaccination is the best way to protect against these life-threatening diseases. Vaccines work by causing the body to produce its own protection (antibodies). Booster doses are needed to keep up immunity because antibody levels may become too low over time to provide the needed protection.

HOW TO USE: Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, consult your health care provider.

This medication is given by injection into a muscle by a health care professional. It is usually given in the upper arm.

This vaccine may be given at the same time as other vaccines (such as hepatitis B) using a separate needle and injection site.

Disclaimer

Boostrix Consumer (continued)

SIDE EFFECTS: Pain, swelling, or redness at the injection site may occur. Headache, tiredness, body aches, nausea, diarrhea, fever, chills, vomiting, or sore/swollen joints may also occur. Acetaminophen or ibuprofen (non-aspirin) may be used to reduce soreness. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: high fever (higher than 104 degrees F/40 degrees C), numbness/tingling, muscle weakness, difficulty breathing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

Read the Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this medication, tell your doctor or pharmacist your medical history, especially of: nervous system disorders (e.g., seizures, encephalopathy, Guillain-Barre syndrome), current illness/infection, bleeding disorders, immune system disorders (e.g., autoimmune disorders, radiation treatment), vaccination history including previous reactions to any vaccines.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Boostrix Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this vaccine include: "blood thinners" (e.g., warfarin), corticosteroids (e.g., hydrocortisone, prednisone), cancer chemotherapy, drugs that suppress the immune system (e.g., cyclosporine, tacrolimus), other vaccines (e.g., diphtheria/tetanus toxoids).

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: There are various combinations of vaccines available. Based on your age, vaccination history, and previous reaction to vaccines, your health care professional will determine the most appropriate one for you. Discuss the risks and benefits of vaccination with your health care provider.

History of infection with tetanus or diphtheria does not always protect against future infections with these bacteria. You should still receive this vaccine if your doctor orders it for you.

MISSED DOSE: It is important to receive each vaccination as scheduled. Be sure to make a note of when the vaccination was last given for your medical record.

STORAGE: Not applicable. This vaccine is given in a doctor's office and will not be stored at home.

Information last revised July 2011. Copyright(c) 2011 First Databank, Inc.

Boostrix Patient Information Including Side Effects

Brand Names: Adacel (Tdap), Boostrix (Tdap)

Generic Name: tetanus, diphtheria, acellular pertussis vaccine (Tdap) (Pronunciation: TET a nus, dif THEER ee a, and ay SEL yoo ler per TUS iss)

What is tetanus, diphtheria, acellular pertussis vaccine (Tdap) (Boostrix)?

Tetanus, diphtheria, and pertussis are serious diseases caused by bacteria.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Diphtheria causes a thick coating in the nose, throat, and airways. It can lead to breathing problems, paralysis, heart failure, or death.

Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death.

Diphtheria and pertussis are spread from person to person. Tetanus enters the body through a cut or wound.

The diphtheria, tetanus acellular, and pertussis adult vaccine (also called Tdap) is used to help prevent these diseases in people who are at least 10 years old. Most people in this age group require only one Tdap shot for protection against these diseases.

This vaccine works by exposing you to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the Tdap vaccine may not provide protection from disease in every person.

What are the possible side effects of this vaccine (Boostrix)?

You should not receive a booster vaccine if you had a life threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell your doctor if the previous shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects within 7 days after receiving this vaccine:

  • extreme drowsiness, fainting;
  • seizure (black-out or convulsions); or
  • high fever.

Less serious side effects include:

  • mild fever or chills;
  • redness, pain, tenderness, or swelling where the shot was given;
  • headache or tiredness;
  • joint pain, body aches; or
  • mild nausea, diarrhea, or vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about this vaccine (Boostrix)?

In most cases, tetanus, diphtheria, acellular pertussis vaccine is given in only one dose. Follow your doctor's instructions about receiving a booster dose if needed.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive a booster vaccine if you had a life threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Side Effects Centers

Boostrix Patient Information including How Should I Take

What should I discuss with my healthcare provider before receiving this vaccine (Boostrix)?

You should not receive this vaccine if you have ever had a serious reaction to any vaccine containing diphtheria, pertussis, or tetanus, including extreme drowsiness, fainting, or seizures (convulsions).

You may not be able to receive a Tdap vaccine if you have ever received a similar vaccine that caused any of the following:

  • a very high fever (over 104 degrees);
  • a neurologic disorder or disease affecting the brain;
  • fainting or going into shock;
  • an allergy to latex rubber;
  • severe or uncontrolled epilepsy or other seizure disorder; or
  • Guillain-Barré syndrome (within 6 weeks after receiving a vaccine containing tetanus).

If you have any of these other conditions, your vaccine may need to be postponed or not given at all:

  • a history of seizures;
  • a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);
  • a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or
  • if it has been less than 5 years since you last received a tetanus shot.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

FDA pregnancy category C. It is not known whether this vaccine is harmful to an unborn baby. Before receiving the Tdap vaccine, tell your doctor if you are pregnant.

It is not known whether Tdap vaccine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The adult version of this vaccine (Adacel, Boostrix) should not be given to anyone under the age of 10. Another vaccine is available for use in children younger than 10 years old.

How is this vaccine given (Boostrix)?

This vaccine is injected into a muscle. You will receive this injection in a doctor's office or clinic setting.

In most cases, you will receive only one dose of the tetanus, diphtheria, acellular pertussis vaccine. Follow your doctor's instructions about receiving a booster dose if needed.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.

It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.

Side Effects Centers

Boostrix Patient Information including If I Miss a Dose

What happens if I miss a dose (Boostrix)?

Since this vaccine is given as a one time injection, you are not likely to be on a dosing schedule.

What happens if I overdose (Boostrix)?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine (Boostrix)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after receiving a Tdap vaccine.

What other drugs will affect tetanus, diphtheria, acellular pertussis vaccine (Boostrix)?

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;
  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), etanercept (Enbrel), leflunomide (Arava), and others; or
  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

This list is not complete and other drugs may interact with tetanus, diphtheria, acellular pertussis vaccine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision date: 7/28/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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