Kinrix (Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)
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Kinrix (Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)

KINRIX™ (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine)
(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)

Suspension for Intramuscular Injection

DRUG DESCRIPTION

KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) is a noninfectious, sterile vaccine for intramuscular administration. Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussin toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett). The diphtheria, tetanus, and pertussis components of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) are the same as those in INFANRIX and PEDIARIX and the poliovirus component is the same as that in PEDIARIX.

The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. 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.

Diphtheria and tetanus toxoids and pertussis antigens (inactivated PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide.

The inactivated poliovirus component of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is an enhanced potency component. Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture. Calf serum is sourced from countries the USDA has determined neither have nor are at risk of BSE. After clarification, each viral suspension is purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated with formaldehyde. The 3 purified viral strains are then pooled to form a trivalent concentrate.

Diphtheria and tetanus 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, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. The potency of the inactivated poliovirus component is determined by using the D-antigen ELISA and by a poliovirus neutralizing cell culture assay on sera from previously immunized rats.

Each 0.5-mL dose contains 4.5 mg of NaCl and aluminum adjuvant (not more than 0.6 mg aluminum by assay). Each dose also contains ≤ 100 mcg of residual formaldehyde and ≤ 100 mcg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B are used in the poliovirus vaccine manufacturing process and may be present in the final vaccine at ≤ 0.05 ng neomycin and ≤ 0.01 ng polymyxin B per dose. KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) does not contain a preservative.

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

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

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

Becoming infected with diphtheria, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of...

Read All Potential Side Effects and See Pictures of Kinrix »

What are the precautions when taking diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine (Kinrix)?

Before receiving the vaccine, tell the doctor or pharmacist if you are allergic to it; or to any other vaccine; or to neomycin or polymyxin B; 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 vaccination, tell the doctor or pharmacist your medical history, especially of: current fever/illness, bleeding/blood clotting problems (such as hemophilia, low platelets), immune system problems (such as HIV infection), cancer, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits...

Read All Potential Precautions of Kinrix »

Last reviewed on RxList: 7/23/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

A single dose of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined] for the first three doses and INFANRIX for the fourth dose.

DOSAGE AND ADMINISTRATION

Preparation for Administration

Shake vigorously to obtain a homogeneous, turbid, white suspension. 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. After removal of the dose, any vaccine remaining in the vial should be discarded.

Recommended Dose and Schedule

KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is to be administered as a 0.5-mL dose by intramuscular injection. The preferred site of administration is the deltoid muscle of the upper arm. Do not administer this product intravenously, intradermally, or subcutaneously.

KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) may be used for the fifth dose in the DTaP immunization series and the fourth dose in the IPV immunization series in children 4 through 6 years of age (prior to the seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first three doses and INFANRIX for the fourth dose [see INDICATIONS].

HOW SUPPLIED

Dosage Forms And Strengths

KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is available in 0.5-mL single-dose vials and prefilled TIP-LOK® syringes. Each 0.5-mL dose contains a suspension for injection of diphtheria and tetanus toxoids, acellular pertussis antigens, and inactivated poliovirus types 1, 2, and 3. See DESCRIPTION for the complete listing of ingredients.

Storage And Handling

KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is available in 0.5-mL single-dose vials and disposable prefilled TIP-LOK syringes.

Single-Dose Vials

NDC 58160-812-11 (package of 10)

Single-Dose Prefilled Disposable TIP-LOK Syringes (packaged without needles)

NDC 58160-812-46 (package of 5)

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, US License 1617 and Novartis Vaccines and Diagnostics GmbH & Co. KG Marburg, Germany, US License 1754. Distributed by GlaxoSmithKline Research Triangle Park, NC 27709. FDA Rev date: 6/24/2008

Last reviewed on RxList: 7/23/2008
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 with rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice.

A total of 3,537 children were vaccinated with a single dose of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) in 3 clinical trials. Of these, 381 children received a non-US formulation of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) (containing ≤ 2.5 mg 2-phenoxyethanol per dose as preservative). The primary study (Study 048), conducted in the United States, was a randomized, controlled clinical trial in which children 4 to 6 years of age were vaccinated with KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) (N = 3,156) or control vaccines (INFANRIX and IPOL® vaccine [IPV, Sanofi Pasteur SA]; N = 1,053) as a fifth DTaP vaccine dose following 4 doses of INFANRIX and as a fourth IPV dose following 3 doses of IPOL. Subjects also received the second dose of US-licensed measles, mumps, and rubella (MMR) vaccine (Merck & Co., Inc.) administered concomitantly, at separate sites.

Data on adverse events were collected by parents/guardians using standardized forms for 4 consecutive days following vaccination with KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) or control vaccines (i.e., day of vaccination and the next 3 days). The reported frequencies of solicited local reactions and general adverse events in Study 048 are presented in Table 1.

In 3 studies (Study 046, 047, and 048), children were monitored for unsolicited adverse events, including serious adverse events, that occurred in the 31-day period following vaccination and in 2 studies (Study 047 and 048), parents/guardians were actively queried about changes in the child's the occurrence of serious adverse events, throughhealth status, 6 months post vaccination.

Table 1. Percentage of Children 4 to 6 Years of Age Reporting Solicited Local Reactions or General Adverse Events Within 4 Days of Vaccination* With KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) or Separate Concomitant Administration of INFANRIX and IPV When Coadministered With MMR Vaccine (Study 048) (Total Vaccinated Cohort)

  KINRIX INFANRIX + IPV
Local N = 3,121-3,128 N = 1,039-1,043
Pain, any 57.0 53.3
Pain, grade 2 or 3§ 13.7 12.0
Pain, grade 3§ 1.6 0.6
Redness, any 36.6 36.6
Redness, ≥ 50 mm 17.6 20.0
Redness, ≥ 110 mm 2.9 4.1
Arm circumference increase, any 36.0 37.8
Arm circumference increase, >20 mm 6.9 7.4
Arm circumference increase, >30 mm 2.4 3.2
Swelling, any 26.0 27.0
Swelling, ≥ 50 mm 10.2 11.5
Swelling, ≥ 110 mm 1.4 1.8
General N = 3,037-3,120 N = 993-1,036
Drowsiness, any 19.1 17.5
Drowsiness, grade 3|| 0.8 0.8
Fever, ≥ 99.5° F 16.0 14.8
Fever, >100.4° F 6.5‡4.4
Fever, >102.2° F 1.1 1.1
Fever, >104° F 0.1 0.0
Loss of appetite, any 15.5 16.0
Loss of appetite, grade 3 0.8 0.6
IPV manufactured by Sanofi Pasteur SA. MMR vaccine manufactured by Merck & Co., Inc.
Total Vaccinated Cohort = all vaccinated subjects for whom safety data were available.
N = number of children with evaluable data for the events listed.
*Within 4 days of vaccination defined as day of vaccination and the next 3 days.
Local reactions at the injection site for KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) or INFANRIX.
Statistically higher than comparator group (p < 0.05).
§Grade 2 defined as painful when the limb was moved; Grade 3 defined as preventing normal daily activities.
|| Grade 3 defined as preventing normal daily activities.
Grade 3 defined as not eating at all.

In Study 048, KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) was non-inferior to INFANRIX with regard to swelling that involved > 50% of the injected upper arm length and that was associated with a > 30 mm increase in mid-upper arm circumference within 4 days following vaccination (upper limit of two-sided 95% Confidence Interval for difference in percentage of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) [0.6%, n = 20] minus INFANRIX [1.0%, n = 11] ≤ 2%).

Serious Adverse Events: Within the 31-day period following study vaccination in 3 studies (Study 046, 047, and 048), in which all subjects received concomitant MMR vaccine (US licensed MMR vaccine [Merck & Co., Inc.] in Study 047 and 048; non-US licensed MMR vaccine in Study 046), 3 subjects (0.1% [3/3,537]) who received KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) reported serious adverse events (dehydration and hypernatremia; cerebrovascular accident; dehydration and gastroenteritis) and 4 subjects (0.3% [4/1,434]) who received INFANRIX and IPV (Sanofi Pasteur SA) reported serious adverse events (cellulitis; constipation; foreign body trauma; fever without identified etiology).

Postmarketing Experience

In addition to reports in clinical trials, the following adverse events, for which a causal relationship to components of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is plausible, have been reported since market introduction of DTaP-IPV manufactured by GlaxoSmithKline outside the U.S. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination.

General Disorders and Administration Site Conditions: Injection site vesicles.

Skin and Subcutaneous Tissue Disorders: Pruritus. Additional adverse events reported following postmarketing use of INFANRIX, for which a causal relationship to vaccination is plausible, are: Allergic reactions, including anaphylactoid reactions, anaphylaxis, angioedema, and urticaria, apnea, collapse or shock-like state (hypotonic-hyporesponsive episode), convulsions (with or without fever), lymphadenopathy, and thrombocytopenia.

Read the Kinrix (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Concomitant Vaccine Administration

In clinical trials, KINRIX was administered concomitantly with the second dose of MMR vaccine [see Clinical Studies].

Data are not available on concomitant use of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) and varicella vaccine.

When KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is administered concomitantly with other injectable vaccines, they should be given with separate syringes. KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) 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 KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) .

Last reviewed on RxList: 7/23/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Guillain-Barre Syndrome

If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) , should be based on careful consideration of the potential benefits and possible risks. When a decision is made to withhold tetanus toxoid, other available vaccines should be given, as indicated.

Latex

The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals. The vial stopper is latex-free.

Adverse Events Following Prior Pertussis Vaccination

If any of the following events occur in temporal relation to receipt of a pertussis­containing vaccine, the decision to give any pertussis-containing vaccine, including KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) ,

should be based on careful consideration of the potential benefits and possible risks:

  • Temperature of ≥ 40.5°C (105°F) within 48 hours not due to another identifiable cause;
  • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours;
  • Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours;
  • Seizures with or without fever occurring within 3 days.

When a decision is made to withhold pertussis vaccination, other available vaccines should be given, as indicated.

Children at Risk for Seizures

For children at higher risk for seizures than the general population, an appropriate antipyretic may be administered at the time of vaccination with a pertussis-containing vaccine, including KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) , and for the ensuing 24 hours to reduce the possibility of post-vaccination fever.

Preventing and Managing Allergic Vaccine Reactions

Prior to administration, the healthcare provider should review the 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

KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) 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 KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) . It is also not known whether KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Pediatric Use

Safety and effectiveness of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) in children younger than 4 years of age and children 7 to 16 years of age have not been evaluated. KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is not approved for use in persons in these age groups.

Last reviewed on RxList: 7/23/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

Hypersensitivity

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid, tetanus toxoid, pertussis or poliovirus-containing vaccine, or to any component of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) , including neomycin and polymyxin B, is a contraindication to administration of KINRIX [see DESCRIPTION]. Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. 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-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis­containing vaccine, including KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) .

Progressive Neurologic Disorder

Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy is a contraindication to administration of any pertussis-containing vaccine, including KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) . Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized.

Last reviewed on RxList: 7/23/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

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 is the lowest level giving some degree of protection; a level of 0.1 IU/mL is regarded as protective.1

Tetanus: Tetanus is an acute toxin-mediated disease 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 IU/mL, measured by neutralization assays, is considered the minimum protective level.2,3 A level of ≥ 0.1 IU/mL is considered protective.4

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. There is no well established serological correlate of protection for pertussis. The efficacy of the pertussis component of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) was determined in clinical trials of INFANRIX administered as a 3-dose series in infants (see INFANRIX prescribing information).

Poliomyelitis: Poliovirus is an enterovirus that belongs to the picornavirus family. Three serotypes of poliovirus have been identified (Types 1, 2, and 3). Neutralizing antibodies against the 3 poliovirus serotypes are recognized as conferring protection against poliomyelitis disease.5

Clinical Studies

Immunological Evaluation

In a US multicenter study (Study 048), 4,209 children were randomized in a 3:1 ratio to receive either KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) or INFANRIX and IPV (Sanofi Pasteur SA) administered concomitantly at separate sites. Subjects also received MMR vaccine (Merck & Co., Inc.) administered concomitantly at a separate site. Subjects were children 4 through 6 years of age who previously received 4 doses of INFANRIX, 3 doses of IPV, and 1 dose of MMR vaccine. Among subjects in both vaccine groups combined, 49.6% were female; 45.6% of subjects were White, 18.8% Hispanic, 13.6% Asian, 7.0% Black, and 15.0% were of other racial/ethnic groups.

Levels of antibodies to the diphtheria, tetanus, pertussis (PT, FHA, and pertactin), and poliovirus antigens were measured in sera obtained immediately prior to vaccination and 1 month (range 31 to 48 days) after vaccination (Table 2). The co-primary immunogenicity endpoints were anti-diphtheria toxoid, anti-tetanus toxoid, anti-PT, anti-FHA, and anti-pertactin booster responses, and anti-poliovirus Type 1, Type 2, and Type 3 geometric mean antibody titers (GMTs) 1 month after vaccination. KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) was shown to be non-inferior to INFANRIX and IPV administered separately, in terms of booster responses to DTaP antigens and post­vaccination GMTs for anti-poliovirus antibodies (Table 2).

Table 2. Pre-vaccination Antibody Levels and Post-vaccination* Antibody Responses Following KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) Compared With Separate Concomitant Administration of INFANRIX and IPV in Children 4 to 6 Years of Age When Coadministered With MMR Vaccine (Study 048) (ATP Cohort for Immunogenicity)

  KINRIX INFANRIX + IPV
  N = 787-851 N = 237-262
Anti-Diphtheria Toxoid
  Pre-vaccination % ≥ 0.1 IU/mL (95% CI) 87.7 (85.3, 89.9) 85.5 (80.6, 89.5)
  Post-vaccination % ≥ 0.1 IU/mL (95% CI) 100 (99.6, 100) 100 (98.6, 100)
  % Booster Response (95% CI) 99.5 (98.8, 99.9)§ 100 (98.6, 100)
Anti-Tetanus Toxoid
  Pre-vaccination % ≥ 0.1 IU/mL (95% CI) 87.8 (85.4, 90.0) 88.2 (83.6, 91.8)
  Post-vaccination % ≥ 0.1 IU/mL (95% CI) 100 (99.6, 100) 100 (98.6, 100)
  % Booster Response (95% CI) 96.7 (95.2, 97.8)§ 93.9 (90.2, 96.5)
Anti-PT
  % Booster Response (95% CI)|| 92.2 (90.2, 94.0)§ 92.6 (88.7, 95.5)
Anti-FHA
  % Booster Response (95% CI)|| 95.4 (93.7, 96.7)§ 96.2 (93.1, 98.1)
Anti-Pertactin
  % Booster Response (95% CI)|| 97.8 (96.5, 98.6)§ 96.9 (94.1, 98.7)
Anti-Poliovirus 1
  Pre-vaccination % ≥ 1:8 (95% CI) 88.3 (85.9, 90.4) 85.1 (80.1, 89.2)
  Post-vaccination % ≥ 1:8 (95% CI) 99.9 (99.3, 100) 100 (98.5, 100)
  Post-vaccination GMT (95% CI) 2,127 (1,976, 2,290) 1,685 (1,475, 1,925)
Anti-Poliovirus 2
  Pre-vaccination % ≥ 1:8 (95% CI) 91.8 (89.7, 93.6) 87.0 (82.3, 90.8)
  Post-vaccination % ≥ 1:8 (95% CI) 100 (99.6, 100) 100 (98.5, 100)
  Post-vaccination GMT (95% CI) 2,265 (2,114, 2,427) 1,818 (1,606, 2,057)
Anti-Poliovirus 3
  Pre-vaccination % ≥ 1:8 (95% CI) 84.7 (82.0, 87.0) 85.0 (80.1, 89.1)
  Post-vaccination % ≥ 1:8 (95% CI) 100 (99.5, 100) 100 (98.5, 100)
  Post-vaccination GMT (95% CI) 3,588 (3,345, 3,849) 3,365 (2,961, 3,824)
IPV manufactured by Sanofi Pasteur SA. MMR vaccine manufactured by Merck & Co., Inc.
ATP = according-to-protocol; CI = Confidence Interval; GMT = geometric mean antibody titer
N = number of subjects with available results.
*One month blood sampling, range 31 to 48 days.
Seroprotection defined as anti-diphtheria toxoid and anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL by ELISA and as anti-poliovirus Type 1, Type 2, and Type 3 antibody titer ≥ 1:8 by micro-neutralization assay for poliovirus.
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.
§KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) was non-inferior to INFANRIX + IPV based on booster response rates (upper limit of two-sided 95% CI on the difference of INFANRIX + IPV minus KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) ≤ 10%).
|| Booster response: In subjects with pre-vaccination < 5 EL.U./mL, post-vaccination concentration ≥ 20 EL.U./mL. In subjects with pre-vaccination ≥ 5 EL.U./mL and < 20 EL.U./mL, an increase of at least 4 times the pre-vaccination concentration. In subjects with pre-vaccination ≥ 20 EL.U./mL, an increase of at least 2 times the pre-vaccination concentration.
KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) was non-inferior to INFANRIX + IPV based on post-vaccination anti-poliovirus antibody GMTs adjusted for baseline titer (upper limit of two-sided 95% CI for the GMT ratio [INFANRIX + IPV:KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) ] ≤ 1.5).

Concomitant Vaccine Administration

In a US study (Study 047), among recipients of DTaP-IPV (same formulation as KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) but also containing 2-phenoxyethanol) and the second dose of MMR vaccine (Merck & Co., Inc.) who had pre-vaccination sera tested for antibodies to measles, mumps, and rubella (N = 175-181), 99% of subjects were seropositive for antibodies to measles, mumps, and rubella prior to vaccination.

REFERENCES

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

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. Department of Health and Human Services, Food and Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review; Proposed rule. Federal Register December 13, 1985;50(240):51002-51117.

4. Centers for Disease Control and Prevention. General Recommendations on Immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(RR-15):1-48.

5. Sutter RW, Pallansch MA, Sawyer LA, et al. Defining surrogate serologic tests with respect to predicting protective vaccine efficacy: Poliovirus vaccination. In: Williams JC, Goldenthal KL, Burns DL, Lewis Jr BP, eds. Combined vaccines and simultaneous administration. Current issues and perspectives. New York, NY: The New York Academy of Sciences; 1995:289-299.

Last reviewed on RxList: 7/23/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

  • Parents or guardians should be informed by the healthcare provider of the potential benefits and risks of immunization with KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) .
  • The healthcare provider should inform the parents or guardians about the potential for adverse reactions that have been temporally associated with administration of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) or other vaccines containing similar components.
  • The parent or guardian accompanying the recipient should be instructed to report any adverse events to their healthcare provider where the vaccine was administered.
  • The parent or guardian should be 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).

KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is a trademark and INFANRIX, PEDIARIX, and TIP-LOK are registered trademarks of GlaxoSmithKline. IPOL is a registered trademark of Sanofi Pasteur Limited.

Last reviewed on RxList: 7/23/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

  • Parents or guardians should be informed by the healthcare provider of the potential benefits and risks of immunization with KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) .
  • The healthcare provider should inform the parents or guardians about the potential for adverse reactions that have been temporally associated with administration of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) or other vaccines containing similar components.
  • The parent or guardian accompanying the recipient should be instructed to report any adverse events to their healthcare provider where the vaccine was administered.
  • The parent or guardian should be 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).

KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is a trademark and INFANRIX, PEDIARIX, and TIP-LOK are registered trademarks of GlaxoSmithKline. IPOL is a registered trademark of Sanofi Pasteur Limited.

Last reviewed on RxList: 7/23/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Kinrix 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/PERTUSSIS/POLIO VACCINE - INJECTION

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

COMMON BRAND NAME(S): Kinrix

USES: This medication is a combination of vaccines against diphtheria, tetanus (lockjaw), pertussis (whooping cough), and polio. Vaccination is the best way to protect against these life-threatening infections. Vaccines work by causing the body to produce its own protection (antibodies).

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

Vaccines are usually given in a series of doses to provide the best protection. Closely follow the vaccination schedule provided by the doctor. Keep all scheduled medical appointments. It may be helpful to mark a calendar as a reminder. There are various combinations of vaccines available. Discuss the risks and benefits of vaccination with the health care professional.

Disclaimer

Kinrix Consumer (continued)

SIDE EFFECTS: Pain/swelling/redness at the injection site may occur. Mild fever, drowsiness, tiredness, headache, nausea, and loss of appetite may also occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly. Consult the doctor or pharmacist about the temporary use of acetaminophen to treat pain and fever due to this vaccine.

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 any of these rare but serious side effects occur: high fever (105 degrees F/40 degrees C or higher), numbness/tingling, muscle weakness, difficulty breathing, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 the 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 Kinrix (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before receiving the vaccine, tell the doctor or pharmacist if you are allergic to it; or to any other vaccine; or to neomycin or polymyxin B; 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 vaccination, tell the doctor or pharmacist your medical history, especially of: current fever/illness, bleeding/blood clotting problems (such as hemophilia, low platelets), immune system problems (such as HIV infection), cancer, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Kinrix 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 drug include: corticosteroids taken by mouth or given by injection (such as dexamethasone), drugs that weaken the immune system (such as azathioprine, cyclosporine, cancer chemotherapy).

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. Canada residents can call a provincial poison control center.

NOTES: Keep vaccine records for yourself and all of your children, and after your children are grown provide their records to them and their doctors. This will prevent unnecessary re-vaccinations.

MISSED DOSE: It is important that you or your child receives each vaccination as scheduled. Be sure to make a note of when you or your child received the last vaccination.

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.

Kinrix Patient Information Including Side Effects

Brand Names: Kinrix

Generic Name: diphtheria, pertussis acellular, tetanus, and polio (Pronunciation: dif THEER ee a, per TUS is a SEL yoo lar, TET a nus, POE lee oh)

What is diphtheria, pertussis acellular, tetanus, and polio vaccine (Kinrix)?

Diphtheria, pertussis acellular, tetanus, and polio are serious diseases caused by bacteria.

Diphtheria causes a thick coating in the nose, throat, and airway. 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.

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.

Polio affects the central nervous system and spinal cord. It can cause muscle weakness and paralysis. Polio is a life-threatening condition because it can paralyze the muscles that help you breathe.

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

The diphtheria, pertussis acellular, tetanus, and polio vaccine is used to help prevent these diseases in children who are ages 4 through 6 years (before the 7th birthday) who have received prior vaccination with a DTaP and IPV series.

This vaccine works by exposing your child 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 diphtheria, pertussis acellular, tetanus, and polio vaccine may not provide protection from disease in every person.

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

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

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

Becoming infected with diphtheria, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. 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 the child has any of these serious side effects:

  • extreme drowsiness, fainting;
  • fussiness, irritability, crying for an hour or longer;
  • seizure (black-out or convulsions); or
  • high fever.

Less serious side effects may include:

  • redness, pain, tenderness, or swelling where the shot was given;
  • drowsiness;
  • mild fussiness or crying;
  • low fever; or
  • loss of appetite.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Kinrix (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) Side Effects Center for a complete guide to possible side effects »

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

The diphtheria, pertussis acellular, tetanus, and polio vaccine is given as the 5th dose in a series of DTaP immunizations and the 4th dose in a series of IPV immunizations. The shot is usually given to a child who is at least 4 years old or has not yet reached his or her 7th birthday. Your child's individual dose schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Be sure your child receives all recommended doses in the DTaP and IPV series. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive this vaccine if he or she had a life-threatening allergic reaction to a vaccine containing diphtheria, pertussis, tetanus, or polio.

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

Becoming infected with diphtheria, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Side Effects Centers

Kinrix Patient Information including How Should I Take

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

Your child should not receive this vaccine if he or she had a life-threatening allergic reaction to a vaccine containing diphtheria, pertussis, tetanus, or polio.

Your child should not receive this vaccine if the child has had a decreased level of consciousness within the past 7 days, or if the child has a neurologic disorder or disease affecting the brain.

Your child may not be able to receive this vaccine if he or she has ever received a similar vaccine that caused any of the following within 48 hours:

  • a very high fever (over 104 degrees);
  • excessive crying for 3 hours or longer;
  • fainting or going into shock;
  • seizure (convulsions); or
  • Guillain-Barré syndrome (within 6 weeks after receiving a vaccine containing tetanus).

Before receiving this vaccine, tell the doctor if your child has:

  • a history of seizures;
  • an allergy to latex rubber;
  • if the child is using steroid medication or receiving cancer chemotherapy or radiation treatment; or
  • a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

How is this vaccine given (Kinrix)?

This vaccine is given as an injection into a muscle. Your child will receive this injection in a doctor's office or other clinic setting.

The diphtheria, pertussis acellular, tetanus, and polio vaccine is given as the 5th dose in a series of DTaP immunizations and the 4th dose in a series of IPV immunizations. The shot is usually given to a child who is at least 4 years old or has not yet reached his or her 7th birthday. Your child's individual dose schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

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 give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

Side Effects Centers

Kinrix Patient Information including If I Miss a Dose

What happens if I miss a dose (Kinrix)?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure your child receives all recommended doses in the DTaP and IPV series. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

What happens if I overdose (Kinrix)?

An overdose of this vaccine is unlikely to occur.

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

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

What other drugs will affect diphtheria, pertussis acellular, tetanus, and polio vaccine (Kinrix)?

Before receiving this vaccine, tell the doctor about all other vaccines your child has recently received.

Also tell the doctor if your child has received drugs or treatments in the past 2 weeks 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), efalizumab (Raptiva), 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).

If your child is using any of these drugs, this vaccine may not work as well.

This list is not complete and there may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications your child has received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your child's 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: 1.03. Revision date: 12/15/2010.

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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Side Effects Centers

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