Japanese Encephalitis Vaccine (Ixiaro)
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Japanese Encephalitis Vaccine (Ixiaro)

IXIARO
(japanese encephalitis vaccine, inactivated, adsorbed) Suspension for Intramuscular Injection

DRUG DESCRIPTION

IXIARO, Japanese Encephalitis Vaccine, Inactivated, Adsorbed is a sterile suspension for intramuscular injection. Each dose of vaccine contains approximately 6 mcg of purified, inactivated JEV proteins and 250 mcg of aluminum hydroxide. The appearance of the liquid is a white, opaque, non-uniform suspension which becomes homogeneous upon shaking. As IXIARO (japanese encephalitis vaccine) is inactivated, it cannot cause Japanese Encephalitis.

IXIARO (japanese encephalitis vaccine) is a vaccine prepared by propagating JEV strain SA14-14-2 in Vero cells. Multiple viral harvests are performed, which are pooled, clarified and concentrated. The virus suspension is treated with protamine sulfate to remove contaminating DNA and proteins. The resulting partially purified virus is processed through a sucrose density gradient centrifugation step and fractionated. Each fraction is analyzed for the presence of virus, and fractions with the highest virus activity are pooled to give a purified virus suspension. The purified virus is then inactivated by treatment with formaldehyde. The preparation is adjusted to a specified protein concentration and formulated by addition of aluminum hydroxide.

The formulated bulk vaccine is filled into syringes, at a volume of 0.5 mL per syringe. From the manufacturing process, IXIARO (japanese encephalitis vaccine) also contains: formaldehyde (not more than 200 ppm), bovine serum albumin (not more than 100 ng/mL), host cell DNA (not more than 200 pg/mL), sodium metabisulphite (not more than 200 ppm), host cell proteins (not more than 300 ng/mL), and protamine sulfate (not more than 1μg/mL). No preservatives, stabilizers, or antibiotics are added to the formulation.

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

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 shots caused any side effects.

Becoming infected with Japanese encephalitis is much more dangerous to your health than receiving the vaccine to protect against it. 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...

Read All Potential Side Effects and See Pictures of Ixiaro »

Last reviewed on RxList: 3/11/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

IXIARO (japanese encephalitis vaccine) is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus (JEV) in persons 17 years of age and older.

DOSAGE AND ADMINISTRATION

Immunization Series

Immunization with IXIARO (japanese encephalitis vaccine) consists of 2 doses administered 28 days apart. Immunization series should be completed at least 1 week prior to potential exposure to JEV.

Administration

Before administration, shake the syringe well to obtain a white, opaque, homogeneous suspension. Do not administer if particulate matter remains following shaking or if discoloration is observed.

Each 0.5 mL dose of IXIARO (japanese encephalitis vaccine) is administered intramuscularly into the deltoid muscle. Do not administer intravenously, intradermally, or subcutaneously.

HOW SUPPLIED

Dosage Forms And Strengths

IXIARO (japanese encephalitis vaccine) is a suspension for injection supplied in 0.5 mL single dose syringes. [See DESCRIPTION]

Storage And Handling

IXIARO (japanese encephalitis vaccine) is supplied as a sterile 0.5 mL suspension in a pre-filled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer) in a pack size of 1 syringe with or without a separate needle. NDC 42515-001-01.

None of the syringe or packaging materials contain latex.

Storage Conditions

Store in a refrigerator at 2° to 8° C (35° to 46° F). Do not freeze.

Do not use the vaccine after the expiration date shown on the label. Store in the original package in order to protect from light. During storage, a clear liquid with a white precipitate can be observed.

Handling

Prior to agitation, IXIARO (japanese encephalitis vaccine) may appear as a clear liquid with a white precipitate. After thorough agitation, it forms a white, cloudy liquid/suspension. The vaccine should be visually inspected for coarse particulate matter and discoloration prior to administration. Discard the product if particulates are present or if it appears discolored or if the syringe appears to be physically damaged.

Any unused product or waste material should be disposed of in accordance with local requirements.

Issued January 2009. Manufactured by: Intercell Biomedical, Oakbank Park Road, EH51 0TG, Livingston, UK. T: +44.1506.446.600. F: +44.1506.446.601. www.intercell.com. Distributed by: Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue Cambridge, Massachusetts 02139, US.

Last reviewed on RxList: 3/11/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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.

Overall Adverse Events

The most common ( ≥ 10%) systemic adverse events observed in clinical trials with IXIARO (japanese encephalitis vaccine) were headache and myalgia. The most common ( ≥ 10%) local reactions after IXIARO (japanese encephalitis vaccine) administration were pain and tenderness.

In five clinical studies1, 2, 3, 4, 5 conducted in North America, Europe, Australia and New Zealand, a total of 3,558 adults aged 18 to 86 years received at least one dose of IXIARO (japanese encephalitis vaccine) (92% completed the 2 dose series) and were followed-up for safety for at least 6 months after the first dose. In this pooled dataset of subjects who received IXIARO (japanese encephalitis vaccine) , one death occurred in a subject with metastatic lung adenocarcinoma four months after completing the two-dose regimen. Approximately 1% of subjects who received IXIARO (japanese encephalitis vaccine) experienced a serious adverse event, including one case of multiple sclerosis. Approximately 1% of subjects who received IXIARO (japanese encephalitis vaccine) discontinued due to adverse events.

Clinical Trials Experience

Adverse Events in a Clinical Trial Comparing IXIARO (japanese encephalitis vaccine) to a Control

The safety of IXIARO (japanese encephalitis vaccine) was evaluated in a randomized, controlled, double-blind clinical trial in healthy male and female subjects1. IXIARO (japanese encephalitis vaccine) was compared to a control: Phosphate Buffered Saline containing 0.1% aluminum hydroxide [PBS + Al(OH)3]. A total of 2,675 subjects were randomized in a 3:1 ratio to receive either an intramuscular injection of IXIARO (japanese encephalitis vaccine) (0.5 mL) each on Day 0 and Day 28, or an intramuscular injection of PBS + Al(OH)3 (0.5 mL) each on Day 0 and Day 28. Analysis of safety was carried out using the safety population including 1,993 subjects receiving at least one dose of IXIARO (japanese encephalitis vaccine) and 657 subjects receiving at least one dose of PBS + Al(OH)3 (mean age: 33.8 years, range 18 to 86 years; 55.3% female; race: White: 91.7%, Asian: 1.8%, Black: 3.4%, Other: 3.0%). The IXIARO (japanese encephalitis vaccine) and control groups were similar with regard to demographics. Subjects recorded adverse events on a diary card for the first seven days after each vaccination. In addition, the study investigator took a medical history and performed a physical exam to evaluate for adverse events on the day of each vaccination and at a visit 4 weeks after the second vaccination.

Serious Adverse Events

No deaths occurred during this trial. Sixteen serious adverse events (SAE) were reported during the study period. Ten subjects (0.5%) who received IXIARO (japanese encephalitis vaccine) and 6 subjects (0.9%) who received PBS + Al(OH)3 experienced a SAE. The serious adverse events occurring in the IXIARO (japanese encephalitis vaccine) group were as follows: dermatomyositis, appendicitis, rectal hemorrhage, limb abscess (contralateral to the injected arm), chest pain, ovarian torsion, ruptured corpus luteal cyst, and three orthopedic injuries.

Systemic Adverse Events

Overall, the percentage of subjects who experienced at least one adverse event during the study period was 58.9% in the IXIARO (japanese encephalitis vaccine) group compared to 56.6% in the PBS + Al(OH)3 group. The severity of adverse events was as follows: mild in 33.7% of subjects receiving IXIARO (japanese encephalitis vaccine) compared to 34.1% of subjects receiving PBS + Al(OH)3, moderate in 20.1% of subjects receiving IXIARO (japanese encephalitis vaccine) compared to 17.4% of subjects receiving PBS + Al(OH)3, and severe in 5.1% of subjects receiving IXIARO (japanese encephalitis vaccine) compared to 5.2% of subjects receiving PBS + Al(OH)3. Severity was defined as follows: Mild, awareness of signs or symptoms, but easily tolerated; Moderate, discomfort enough to interfere with usual activity; and Severe, incapable of work or usual activity. Adverse events of any severity grade occurring with an incidence of ≥ 1% of subjects are shown in Table 1.

Table 1: Common Systemic Adverse Events* After IXIARO (japanese encephalitis vaccine) or Control [PBS + Al(OH)3], Safety Population

Adverse Event Incidence (% of subjects) in the First Vaccination Period
(Day 0 to Day 28)
Incidence (% of subjects) in the
Second Vaccination Period
(Day 28 to Day 56)
Incidence (% of subjects) in the Total Vaccination Period
(Day 0 to Day 56)
IXIARO
N‡=1993
PBS + Al(OH)3
N‡=657
IXIARO
N‡=1968
PBS + Al(OH)3
N‡=645
IXIARO
N‡=1993
PBS + Al(OH)3
N‡=657
Headache† 21.6 20.2 13.4 13.0 27.9 26.2
Myalgia† 13.3 12.9 5.6 5.3 15.6 15.5
Fatigue† 8.6 8.7 5.2 5.9 11.3 11.7
Influenza-like Illness† 8.2 8.5 5.8 4.3 12.3 11.7
Nausea† 4.7 5.3 2.6 3.7 6.6 7.5
Nasopharyngitis 2.3 1.8 2.6 2.3 4.7 4.0
Pyrexia† 1.9 2.1 1.5 1.7 3.2 3.0
Rhinitis 1.0 0.8 0.5 0.6 1.4 1.4
Upper Respiratory Tract Infection 0.9 0.9 0.8 0.9 1.7 2.0
Back Pain 0.8 0.9 0.6 0.2 1.3 1.1
Pharyngolaryngeal Pain 0.8 0.9 1.0 0.5 1.6 1.4
Rash† 0.8 0.9 0.7 0.8 1.3 1.5
Diarrhea 0.8 0.8 0.7 0.3 1.5 1.1
Cough 0.8 0.8 0.6 0.6 1.2 1.2
Vomiting† 0.6 0.8 0.8 0.9 1.4 1.7
*The adverse events in this table are those observed at an incidence of ≥ 1% in the IXIARO (japanese encephalitis vaccine) or PBS + Al(OH)3 groups.
† These symptoms were solicited in a subject diary card. Percentages include unsolicited events that occurred after the 7 day period covered by the diary card.
‡N=number of subjects in the safety population (subjects treated with at least one dose) who received the respective dose

Injection Site Reactions

Injection site reactions after IXIARO (japanese encephalitis vaccine) were compared to reactions after PBS + Al(OH)3. Symptoms were recorded into a subject diary for the first seven days after each injection, and the injection site was assessed by the investigator at each visit. Pain, tenderness, and pruritis severity was assessed subjectively as absent, mild, moderate or severe by the subject. The amount of erythema, induration and edema was measured by the subject and/or the investigator and rated as absent, mild ( ≤ 1cm), moderate ( > 1 to < 3cm), or severe ( ≥ 3cm). The severity of injection site reactions observed after either dose was as follows: mild in 41.6% of subjects receiving IXIARO (japanese encephalitis vaccine) compared to 44.2% of subjects receiving PBS + Al(OH)3, moderate in 9.5% of subjects receiving IXIARO (japanese encephalitis vaccine) compared to 7.7% of subjects receiving PBS + Al(OH)3, and severe in 3.2% of subjects receiving IXIARO (japanese encephalitis vaccine) compared to 3.1% of subjects receiving PBS + Al(OH)3. The frequency of injection site reactions of any severity grade is shown in Table 2.

Table 2: Injection Site Solicited Adverse Reactions* After IXIARO (japanese encephalitis vaccine) or Control [PBS + Al(OH)3], Subjects in the Safety Population With Evaluable Diary Cards

Adverse Reaction Incidence Post Dose 1
(% of subjects†)
Incidence Post Dose 2
(% of subjects†)
Incidence Post Dose 1 or Dose 2 (% of subjects†)
IXIARO
N‡=1963
PBS +Al(OH)3
N‡=645
IXIARO
N‡=1951
PBS +Al(OH)3
N‡=638
IXIARO
N‡=1963
PBS +Al(OH)3
N‡=645
Any Reaction 48.5 47.7 32.6 32.2 55.4 56.2
Pain 27.7 28.2 17.7 18.2 33.0 35.8
Tenderness 28.8 26.9 22.5 18.1 35.9 32.6
Erythema 6.8 5.4 4.6 4.1 9.6 7.4
Induration 4.8 5.3 4.0 3.0 7.5 7.4
Edema 2.4 3.3 2.3 1.6 4.2 4.6
Pruritis 2.6 3.3 1.6 1.9 3.8 4.5
* Injection site reactions were assessed for 7 days after each dose.
† Denominators used to calculate percentages are based on the number of evaluable diary card entries (defined as documented presence on any day [i.e., entry of “yes”] or absence on all days [i.e., entry of “no”]) for each individual symptom and observation period.
‡N=number of subjects who returned diary cards after each dose

Adverse Events in a Clinical Trial Comparing IXIARO (japanese encephalitis vaccine) to JE-VAX

The safety of IXIARO (japanese encephalitis vaccine) compared to another inactivated JE vaccine (JE-VAX) was evaluated in a randomized, double-blind clinical trial2.

No deaths occurred during this trial. One serious adverse event occurred in this trial in a subject with a history of myocardial infarction (MI) who experienced a MI three weeks after receiving the 2nd dose of IXIARO (japanese encephalitis vaccine) . The most common adverse events after immunization occurring in ≥ 1% of subjects were headache, myalgia, fatigue, influenza-like illness, nausea, nasopharyngitis, pyrexia, pharyngolaryngeal pain, cough, rash, diarrhea, sinusitis, upper respiratory tract infection, back pain, migraine, vomiting and influenza, which occurred with similar frequency in both treatment groups. Local injection site reactions solicited in diary cards were observed at a rate of 54% in the IXIARO (japanese encephalitis vaccine) group (N=428) compared to a rate of 69.1% in the JE-VAX group (N=435).

Safety in Concomitant Use with the Hepatitis A Vaccine, HAVRIX3

The safety of IXIARO (japanese encephalitis vaccine) when administered concomitantly with inactivated Hepatitis A Virus vaccine (HAVRIX) was evaluated in a controlled trial in which subjects were assigned randomly to one of three treatment groups: Group A (N=62) received IXIARO (japanese encephalitis vaccine) + HAVRIX; Group B (N=65) received IXIARO (japanese encephalitis vaccine) + control [PBS + Al(OH)3]; Group C (N=65) received HAVRIX + control [PBS + Al(OH)3]. One serious adverse event occurred in this trial in a subject with a history of alcoholism and seizure disorder who experienced a seizure three weeks after receiving the 2nd dose of IXIARO (japanese encephalitis vaccine) + control.

The percentage of subjects who experienced at least one adverse event was as follows: Group A: 38.7%; Group B: 41.5%; Group C: 47.7%. The most frequently reported injection site reaction on the day of the first vaccination in all three groups was injection site pain in 59.0% of subjects in Group A, in 48.4% of subjects in Group B and in 48.4% of subjects in Group C.

Read the Ixiaro (japanese encephalitis vaccine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Use with HAVRIX

In one clinical trial3, IXIARO (japanese encephalitis vaccine) was administered concomitantly with HAVRIX (Hepatitis A Vaccine) [See ADVERSE REACTIONS and Clinical Studies]. In this trial, there was no evidence for interference with the immune response to IXIARO (japanese encephalitis vaccine) or to HAVRIX when HAVRIX was administered concomitantly with dose 1 of IXIARO [See Clinical Studies]. Data are not available on concomitant administration of IXIARO (japanese encephalitis vaccine) with other US-licensed vaccines.

When IXIARO (japanese encephalitis vaccine) is administered concomitantly with injectable vaccines, they should be given with separate syringes at different injection sites. IXIARO (japanese encephalitis vaccine) should not be mixed with any other vaccine in the same syringe or vial.

Use with Immunosuppressive Therapies

There are no data regarding the use of IXIARO (japanese encephalitis vaccine) concomitantly with immunosuppressive therapies, e.g., irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses) [See WARNING AND PRECAUTIONS].

REFERENCES

1. Clinical study referred to as NCT00605085 in the National Library of Medicine clinical trial database, also referred to as study IC51-302 in the Biologics License Application.

2. Clinical study referred to as NCT00604708 in the National Library of Medicine clinical trial database, also referred to as study IC51-301 in the Biologics License Application.

3. Clinical study referred to as NCT00596271 in the National Library of Medicine clinical trial database, also referred to as study IC51-308 in the Biologics License Application.

4. Clinical study referred to as NCT00595790 in the National Library of Medicine clinical trial database, also referred to as study IC51-304 in the Biologics License Application.

5. Clinical study referred to as NCT00594958 in the National Library of Medicine clinical trial database, also referred to as study IC51-309 in the Biologics License Application.

Last reviewed on RxList: 3/11/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Preventing and Managing Allergic Vaccine Reactions

IXIARO (japanese encephalitis vaccine) contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals [See DESCRIPTION]. Appropriate medical care should be readily available in case of anaphylactic reaction.

Limitations of Vaccine Effectiveness

Vaccinees who receive only one dose of IXIARO (japanese encephalitis vaccine) may have a suboptimal response and may therefore incur higher risk if exposed to JEV compared to vaccinees who receive both doses. Vaccination with IXIARO (japanese encephalitis vaccine) may not result in protection in all cases. IXIARO (japanese encephalitis vaccine) will not protect against encephalitis caused by viruses/pathogens other than JEV.

The full duration of protection following immunization is not known [See Clinical Studies]. There are no data regarding timing or efficacy of booster immunization.

Altered Immunocompetence

There are no safety or efficacy data regarding the use of IXIARO (japanese encephalitis vaccine) in immunocompromised individuals. Immunocompromised individuals may have a diminished immune response to IXIARO (japanese encephalitis vaccine) .

Patient Counseling Information

Counseling by the Health Care Provider

Question the vaccine recipient about reactions to previous vaccines, and inform the vaccine recipient of the benefits and risks of IXIARO (japanese encephalitis vaccine) .

Current U.S. and international advisories should be consulted regarding prevalence of Japanese encephalitis in specific locations. Counsel persons traveling to epidemic and endemic areas that IXIARO (japanese encephalitis vaccine) may not fully protect everyone who gets the vaccine and that personal precautions should be taken to reduce exposure to mosquito bites (adequate clothing, use of repellents, mosquito nets). When educating vaccine recipients regarding the potential side effects, explain that IXIARO (japanese encephalitis vaccine) contains formalin-inactivated JEV particles and is, therefore, non-infectious.

Give the required vaccination information to the vaccine recipient, and provide an opportunity to discuss any questions or concerns.

Instruct the vaccine recipient to report any adverse reactions to their health care provider.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

IXIARO (japanese encephalitis vaccine) has not been evaluated for carcinogenic or mutagenic potential. IXIARO (japanese encephalitis vaccine) was found to have no effect on fertility of female rats at intramuscular doses of up to 300-fold excess relative to the projected human dose (on a mg/kg basis) administered prior to and after mating [See Use in Specific Populations]. The effect of IXIARO (japanese encephalitis vaccine) on male fertility has not been evaluated.

Use In Specific Populations

Pregnancy

Pregnancy category B. Reproduction studies have been performed in female rats at doses approximately 300-fold excess relative to the projected human dose (on a mg/kg basis) and have revealed no evidence of impaired fertility or harm to the fetus due to IXIARO (japanese encephalitis vaccine) . There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, IXIARO (japanese encephalitis vaccine) should be used during pregnancy only if clearly needed.

The effect of IXIARO (japanese encephalitis vaccine) vaccine on embryo-fetal and pre-weaning development was evaluated in a developmental toxicity study using pregnant rats. One group of rats was administered IXIARO (japanese encephalitis vaccine) twice prior to gestation and once during the period of organogenesis (gestation Day 6). A second group of pregnant rats was administered IXIARO (japanese encephalitis vaccine) once prior to gestation and once during the period of organogenesis (gestation Day 6). IXIARO (japanese encephalitis vaccine) was administered at 0.5 mL/rat/occasion (approximately 300-fold excess relative to the projected human dose on a mg/kg basis), by intramuscular injection. No adverse effects on mating, fertility, pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There was a statistically significant finding of incomplete ossification in a few fetuses derived from the second group of pregnant rats. However, there are no data to suggest that this finding is vaccine related. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted in this study.

Nursing Mothers

It is not known whether this vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if IXIARO (japanese encephalitis vaccine) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of IXIARO (japanese encephalitis vaccine) in a pediatric population ( < 17 years of age) has not been established.

Geriatric Use

Clinical studies of IXIARO (japanese encephalitis vaccine) did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. The limited dataset from the pivotal efficacy study2 is as follows: in subjects ≥ 65 years of age who received IXIARO (japanese encephalitis vaccine) per protocol (N=24), seroconversion rate was 95.8% and geometric mean titer was 255.2.

In subjects ≥ 65 years of age who had been vaccinated in any of five trials1, 2, 3, 4, 5 included in a pooled dataset (N=161), adverse events were reported in 61.9 % (73/118) of subjects in the IXIARO (japanese encephalitis vaccine) group, 57.7% (15/26) in the JE-VAX group, and 70.6% (12/17) in the control [PBS + Al(OH)3] group. Five serious adverse events (SAE) were reported. Four subjects (3.4%) who received IXIARO (japanese encephalitis vaccine) , no subjects who received JE-VAX, and one subject (5.9%) who received the control [PBS + Al(OH)3] experienced a SAE. The serious adverse events occurring in the IXIARO (japanese encephalitis vaccine) group were as follows: one case each of rectal hemorrhage, pancreatic adenocarcinoma, breast cancer, and one death in a subject with metastatic lung adenocarcinoma, which occurred four months after the subject completed the two-dose regimen.

REFERENCES

1. Clinical study referred to as NCT00605085 in the National Library of Medicine clinical trial database, also referred to as study IC51-302 in the Biologics License Application.

2. Clinical study referred to as NCT00604708 in the National Library of Medicine clinical trial database, also referred to as study IC51-301 in the Biologics License Application.

3. Clinical study referred to as NCT00596271 in the National Library of Medicine clinical trial database, also referred to as study IC51-308 in the Biologics License Application.

4. Clinical study referred to as NCT00595790 in the National Library of Medicine clinical trial database, also referred to as study IC51-304 in the Biologics License Application.

5. Clinical study referred to as NCT00594958 in the National Library of Medicine clinical trial database, also referred to as study IC51-309 in the Biologics License Application.

Last reviewed on RxList: 3/11/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO (japanese encephalitis vaccine) is a contraindication to administration of IXIARO [See DESCRIPTION].

Last reviewed on RxList: 3/11/2010
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Japanese encephalitis is a disease caused by the mosquito-borne Japanese encephalitis virus (JEV). IXIARO (japanese encephalitis vaccine) acts by inducing antibodies that neutralize live JEV.

Clinical Studies

Clinical efficacy trials of JE vaccines have found that neutralizing antibody, as measured by a Plaque Reduction Neutralization Test (PRNT) is protective against JEV infection6. Therefore, the evaluation of the efficacy of IXIARO (japanese encephalitis vaccine) was based on immunogenicity using PRNT as a serological correlate of protection. The World Health Organization consultation group recognizes a PRNT titer of ≥ 1:10 as being a reasonable correlate for protection7.

Clinical Trial2 of Immunogenicity of IXIARO (japanese encephalitis vaccine) – Non-inferiority of IXIARO (japanese encephalitis vaccine) Compared to U.S.-Licensed JE Vaccine, JE-VAX

Immunogenicity of the vaccine was evaluated in a randomized, active-controlled, observer-blinded clinical trial conducted in the U.S., Germany and Austria in 867 healthy male and female subjects 18 to 80 years of age (mean age: 41.3 years; 60.8% female; race: White 80.8%, Asian 0.8%, Black 13.1%, Other 5.3%). Subjects in the IXIARO (japanese encephalitis vaccine) treatment arm received the following schedule of three intramuscular doses: Day 0, 0.5 mL of IXIARO (japanese encephalitis vaccine) , Day 7, PBS + Al(OH)3 (0.5 mL phosphate buffered saline with 0.1% aluminum hydroxide), and on Day 28, 0.5 mL of IXIARO (japanese encephalitis vaccine) . Subjects in the comparator arm received a subcutaneous dose of 1.0 mL of the US-licensed JEV vaccine, JE-VAX, on Days 0, 7 and 28.

The co-primary endpoints were seroconversion rate (SCR), defined as anti-JEV antibody titer ≥ 1:10, and geometric mean titer (GMT) at Day 56 in the per protocol population. The immune responses elicited by IXIARO (japanese encephalitis vaccine) met predefined statistical criteria for non-inferiority compared to those induced by JE-VAX. See Table 3.

Table 3: Seroconversion Rates and Geometric Mean Titers After IXIARO (japanese encephalitis vaccine) or JE-VAX, Per Protocol Population

Seroconversion Rates
Time Point IXIARO (japanese encephalitis vaccine)
SCR (n/N)
[95% CI]
JE-VAX
SCR (n/N)
[95% CI]
Rate difference
[95% CI]
Pre-Vaccination Screen 0 0  
Day 56 (28 days after vaccine dose #2) 96.4% (352/365)
[94.0, 97.9]
93.8% (347/370)
[90.9, 95.8]
2.6%
[-0.5,6.0]†
Geometric Mean Titers
Time Point IXIARO (japanese encephalitis vaccine)
N=365
n (GMT)
[95% CI's]
JE-VAX
N=370n (GMT) [95% CI's]
GMT ratio estimator
[95% CI]
Pre-Vaccination Screen 365 (5.0) 370 (5.0)  
Day 56 (28 days after vaccine dose #2) 361 (243.6)
[ 216.4, 274.1]
364 (102.0)
[90.3, 115.2 ]
2.33
[1.97, 2.75]‡
†Seroconversion Rates (SCRs): Non-inferiority of IXIARO (japanese encephalitis vaccine) compared to JE-VAX for SCRs was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the SCR difference (IXIARO (japanese encephalitis vaccine) minus JE-VAX) was > -10% at Day 56.
‡Geometric Mean Titers (GMTs): Non-inferiority of IXIARO (japanese encephalitis vaccine) compared to JE-VAX for GMTs was demonstrated if the lower bound of the 2-sided 95% CI for the GMT ratio (IXIARO (japanese encephalitis vaccine) /JE-VAX) was > 1/1.5 at Day 56.
◊Pre-Vaccination titers were negative by definition in the PP population and have been imputed to 5.

Follow-up Study of Long Term Immunogenicity (6 months and 12 months)

The persistence of JE-neutralizing antibody was evaluated in a subgroup of subjects recruited for follow-up after participation in one of two clinical trials1, 2. In the Intent-to-Treat (ITT) population of subjects randomized to vaccination with IXIARO (japanese encephalitis vaccine) (N=181), seroconversion rates (SCR) at 6 and 12 months after initiation of the two-dose series were 95% [95%CI 90.8,97.4] and 83.4% [95%CI 77.3,88.1], respectively. Geometric mean titers (GMT) at 6 and 12 months after initiation of the two-dose series were 83.5 [95%CI 70.9,98.4] and 41.2 [95%CI 34.4,49.3], respectively.

Temporal Evaluation of Immunogenicity of IXIARO (japanese encephalitis vaccine) During Vaccination Series

In a randomized, dosing regimen, observer-blinded clinical trial4 in 374 healthy male and female subjects, aged 18-76 years, the immunogenicity of IXIARO (japanese encephalitis vaccine) was evaluated on days 10, 28, 35, and 56 during the vaccination period. Seroconversion rates (SCR) at each time point for the subjects randomized to the standard dosing regimen (IXIARO (japanese encephalitis vaccine) on days 0 and 28) are displayed in Table 4.

Table 4: Seroconversion Rates (SCR) During the Vaccination Series (IXIARO (japanese encephalitis vaccine) on Days 0 and 28), Per Protocol Population

Day 0 (Dose #1 administered) Day 10
(10 days post dose #1)
SCR (n/N)
[95% CI]
Day 28
(28 days post dose #1)
SCR (n/N)
[95% CI]
Day 28 (Dose #2 administered) Day 35
(7 days post dose #2)
SCR (n/N)
[95% CI]
Day 56
(28 days post dose #2)
SCR (n/N)
[95% CI]
21.1% (24/114) 39.8% (45/113) 97.3% (110/113) 97.3% (110/113)
[13.6%; 28.5%] [30.8%; 48.8%] [94.4%; 100.0%] [94.4%, 100%]

Clinical Trial3 of Immunogenicity of IXIARO (japanese encephalitis vaccine) and the Hepatitis A Vaccine, HAVRIX, When Used Concomitantly

The concomitant use of IXIARO (japanese encephalitis vaccine) with inactivated Hepatitis A Virus vaccine (HAVRIX) was evaluated in a randomized, controlled, single-blind clinical trial including 192 healthy male and female subjects aged 18 to 61 years. Subjects were divided into three treatment groups: Group A (N=62) received IXIARO (japanese encephalitis vaccine) + HAVRIX; Group B (N=65) received IXIARO (japanese encephalitis vaccine) + control [PBS + Al(OH)3] (0.5mL phosphate buffered saline with 0.1% aluminum hydroxide by intramuscular injection); Group C (N=65) received HAVRIX + control [PBS + Al(OH)3]. Anti-JEV GMT at Day 56 in Group A met non-inferiority criteria compared to anti-JEV GMT at Day 56 in Group B. In addition, anti-HAV GMT at Day 28 in Group A met non-inferiority criteria compared to anti-HAV GMT at Day 28 in Group C. Therefore, concomitant administration of IXIARO (japanese encephalitis vaccine) and HAVRIX did not adversely affect immunogenicity compared to administration of either vaccine individually. Safety results regarding co-administration of IXIARO (japanese encephalitis vaccine) with HAVRIX are summarized in Section 6.2, Clinical Trials Experience.

REFERENCES

1. Clinical study referred to as NCT00605085 in the National Library of Medicine clinical trial database, also referred to as study IC51-302 in the Biologics License Application.

2. Clinical study referred to as NCT00604708 in the National Library of Medicine clinical trial database, also referred to as study IC51-301 in the Biologics License Application.

4. Clinical study referred to as NCT00595790 in the National Library of Medicine clinical trial database, also referred to as study IC51-304 in the Biologics License Application.

6. Hoke CH, Nisalak A, Sangawhipa N, Jatanasen S, Laorakapongse T, Innis BL, Kotchasenee S, Gingrich JB, Latendresse J, Fukai K, et al. Protection against Japanese encephalitis by inactivated vaccines. N Engl J Med. 1988 Sep 8;319(10):608-14.

7. Hombach J, Solomon T, Kurane I, Jacobson J, Wood D. Report on a WHO consultation on immunological endpoints for evaluation of new Japanese encephalitis vaccines, WHO, Geneva, 2-3 September, 2004. Vaccine. 2005;23:5205-11.

Last reviewed on RxList: 3/11/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

IXIARO (japanese encephalitis vaccine)
(pronounced “ik-se-ah-ro”)
Generic name: Japanese encephalitis vaccine, inactivated, adsorbed

Read this information about IXIARO (japanese encephalitis vaccine) before you are vaccinated. If you have any questions about IXIARO (japanese encephalitis vaccine) after reading this leaflet, ask your health care provider. This leaflet does not take the place of talking with your health care professional about IXIARO (japanese encephalitis vaccine) . Only your health care provider can decide if IXIARO (japanese encephalitis vaccine) is right for you.

What is IXIARO (japanese encephalitis vaccine) and how does it work?

  • IXIARO (japanese encephalitis vaccine) is a vaccine for use in persons 17 years of age and older to help protect against Japanese encephalitis (JE). You cannot get the disease from IXIARO (japanese encephalitis vaccine) .
  • You will need 2 doses of the vaccine.
  • You should still protect yourself from mosquito bites even if you have had the IXIARO (japanese encephalitis vaccine) vaccine.
  • IXIARO (japanese encephalitis vaccine) may not fully protect everyone who gets the vaccine.
  • IXIARO (japanese encephalitis vaccine) does not protect against encephalitis caused by other viruses/pathogens.
  • IXIARO (japanese encephalitis vaccine) does not protect against other diseases transmitted by mosquitoes.

What is Japanese encephalitis virus (JEV) and what is the disease caused by JEV?

Japanese encephalitis (JE) is caused by the Japanese encephalitis virus, JEV, which is mainly found in Asia. JEV is transmitted to humans by mosquitoes that have bitten an infected animal (like pigs). Many infected people develop mild symptoms or no symptoms at all. In people who develop severe disease, JE usually starts as a flu-like illness, with fever, chills, tiredness, headache, nausea, and vomiting. Confusion and agitation also occur in the early stage. JE causes death in one out of every three people with overt encephalitis. One out of two survivors develops permanent brain damage. JE acquired during pregnancy may cause intrauterine infection and miscarriage.

Who is at risk for Japanese encephalitis?

  • People who live in, or travel to, areas where JEV circulates.
  • Laboratory personnel who work with JEV.

Who should not get IXIARO (japanese encephalitis vaccine) ?

You should not get IXIARO (japanese encephalitis vaccine) if you:

  • are allergic to any of the ingredients in the vaccine. A list of ingredients can be found at the end of this leaflet.
  • had an allergic reaction after getting a dose of the vaccine.
  • IXIARO (japanese encephalitis vaccine) is not approved for use in children.

What should I tell my health care professional before I am vaccinated with IXIARO (japanese encephalitis vaccine) ?

It is very important to tell your health care provider if you:

  • have had an allergic reaction to a previous dose of IXIARO (japanese encephalitis vaccine) .
  • have a bleeding disorder or a reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia) and cannot receive injections in the arm.
  • have a weakened immune system, for example, due to a genetic defect or HIV infection.
  • are or may be pregnant, or are breast feeding. IXIARO (japanese encephalitis vaccine) has not been studied in pregnant women or nursing mothers.
  • currently have any illness with a fever of more than 100°F (37.8°C).
  • take any medicines, even those you can buy over the counter.

How is IXIARO (japanese encephalitis vaccine) given?

IXIARO (japanese encephalitis vaccine) is given as an injection in the upper arm muscle. You will get a total of 2 doses of the vaccine. Ideally, the doses are given as:

  • First dose: at a date you and your health care provider choose.
  • Second dose: 28 days after the first dose.

Make sure that you get both doses. If you miss the second dose, your health care provider will decide when to give the missed dose. Be aware that maximum protection may not be achieved until 1 week after you receive the second dose of IXIARO (japanese encephalitis vaccine) .

What are the possible side effects of IXIARO (japanese encephalitis vaccine) ?

The most common side effects are headache, muscle pain and injection site reactions (e.g., pain, swelling, tenderness, redness). Nausea, skin rash, fatigue, flu-like illness, and fever may also occur.

Contact your health care provider right away if you get any symptoms after receiving IXIARO (japanese encephalitis vaccine) that concern you.

Tell your health care provider if you have any of the following problems because these may be signs of an allergic reaction:

What are the ingredients of IXIARO (japanese encephalitis vaccine) ?

Active Ingredient: purified components of inactivated Japanese encephalitis virus (JEV).

Inactive Ingredients: aluminum hydroxide and phosphate buffered saline (sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate).

Minute amounts of other substances remain in the vaccine as a result of the manufacturing process. Refer to the package insert for a complete list.

What else should I know about IXIARO (japanese encephalitis vaccine) ?

This leaflet is a summary of information about IXIARO (japanese encephalitis vaccine) . If you would like more information, please talk to your health care professional. U.S. and international agencies (such as cdc.gov and who.int) also provide additional information about JEV and related travel advisories.

Last reviewed on RxList: 3/11/2010
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

IXIARO (japanese encephalitis vaccine)
(pronounced “ik-se-ah-ro”)
Generic name: Japanese encephalitis vaccine, inactivated, adsorbed

Read this information about IXIARO (japanese encephalitis vaccine) before you are vaccinated. If you have any questions about IXIARO (japanese encephalitis vaccine) after reading this leaflet, ask your health care provider. This leaflet does not take the place of talking with your health care professional about IXIARO (japanese encephalitis vaccine) . Only your health care provider can decide if IXIARO (japanese encephalitis vaccine) is right for you.

What is IXIARO (japanese encephalitis vaccine) and how does it work?

  • IXIARO (japanese encephalitis vaccine) is a vaccine for use in persons 17 years of age and older to help protect against Japanese encephalitis (JE). You cannot get the disease from IXIARO (japanese encephalitis vaccine) .
  • You will need 2 doses of the vaccine.
  • You should still protect yourself from mosquito bites even if you have had the IXIARO (japanese encephalitis vaccine) vaccine.
  • IXIARO (japanese encephalitis vaccine) may not fully protect everyone who gets the vaccine.
  • IXIARO (japanese encephalitis vaccine) does not protect against encephalitis caused by other viruses/pathogens.
  • IXIARO (japanese encephalitis vaccine) does not protect against other diseases transmitted by mosquitoes.

What is Japanese encephalitis virus (JEV) and what is the disease caused by JEV?

Japanese encephalitis (JE) is caused by the Japanese encephalitis virus, JEV, which is mainly found in Asia. JEV is transmitted to humans by mosquitoes that have bitten an infected animal (like pigs). Many infected people develop mild symptoms or no symptoms at all. In people who develop severe disease, JE usually starts as a flu-like illness, with fever, chills, tiredness, headache, nausea, and vomiting. Confusion and agitation also occur in the early stage. JE causes death in one out of every three people with overt encephalitis. One out of two survivors develops permanent brain damage. JE acquired during pregnancy may cause intrauterine infection and miscarriage.

Who is at risk for Japanese encephalitis?

  • People who live in, or travel to, areas where JEV circulates.
  • Laboratory personnel who work with JEV.

Who should not get IXIARO (japanese encephalitis vaccine) ?

You should not get IXIARO (japanese encephalitis vaccine) if you:

  • are allergic to any of the ingredients in the vaccine. A list of ingredients can be found at the end of this leaflet.
  • had an allergic reaction after getting a dose of the vaccine.
  • IXIARO (japanese encephalitis vaccine) is not approved for use in children.

What should I tell my health care professional before I am vaccinated with IXIARO (japanese encephalitis vaccine) ?

It is very important to tell your health care provider if you:

  • have had an allergic reaction to a previous dose of IXIARO (japanese encephalitis vaccine) .
  • have a bleeding disorder or a reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia) and cannot receive injections in the arm.
  • have a weakened immune system, for example, due to a genetic defect or HIV infection.
  • are or may be pregnant, or are breast feeding. IXIARO (japanese encephalitis vaccine) has not been studied in pregnant women or nursing mothers.
  • currently have any illness with a fever of more than 100°F (37.8°C).
  • take any medicines, even those you can buy over the counter.

How is IXIARO (japanese encephalitis vaccine) given?

IXIARO (japanese encephalitis vaccine) is given as an injection in the upper arm muscle. You will get a total of 2 doses of the vaccine. Ideally, the doses are given as:

  • First dose: at a date you and your health care provider choose.
  • Second dose: 28 days after the first dose.

Make sure that you get both doses. If you miss the second dose, your health care provider will decide when to give the missed dose. Be aware that maximum protection may not be achieved until 1 week after you receive the second dose of IXIARO (japanese encephalitis vaccine) .

What are the possible side effects of IXIARO (japanese encephalitis vaccine) ?

The most common side effects are headache, muscle pain and injection site reactions (e.g., pain, swelling, tenderness, redness). Nausea, skin rash, fatigue, flu-like illness, and fever may also occur.

Contact your health care provider right away if you get any symptoms after receiving IXIARO (japanese encephalitis vaccine) that concern you.

Tell your health care provider if you have any of the following problems because these may be signs of an allergic reaction:

What are the ingredients of IXIARO (japanese encephalitis vaccine) ?

Active Ingredient: purified components of inactivated Japanese encephalitis virus (JEV).

Inactive Ingredients: aluminum hydroxide and phosphate buffered saline (sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate).

Minute amounts of other substances remain in the vaccine as a result of the manufacturing process. Refer to the package insert for a complete list.

What else should I know about IXIARO (japanese encephalitis vaccine) ?

This leaflet is a summary of information about IXIARO (japanese encephalitis vaccine) . If you would like more information, please talk to your health care professional. U.S. and international agencies (such as cdc.gov and who.int) also provide additional information about JEV and related travel advisories.

Last reviewed on RxList: 3/11/2010
This monograph has been modified to include the generic and brand name in many instances.

IXIARO
(japanese encephalitis vaccine, inactivated, adsorbed) Suspension for Intramuscular Injection

DRUG DESCRIPTION

IXIARO, Japanese Encephalitis Vaccine, Inactivated, Adsorbed is a sterile suspension for intramuscular injection. Each dose of vaccine contains approximately 6 mcg of purified, inactivated JEV proteins and 250 mcg of aluminum hydroxide. The appearance of the liquid is a white, opaque, non-uniform suspension which becomes homogeneous upon shaking. As IXIARO (japanese encephalitis vaccine) is inactivated, it cannot cause Japanese Encephalitis.

IXIARO (japanese encephalitis vaccine) is a vaccine prepared by propagating JEV strain SA14-14-2 in Vero cells. Multiple viral harvests are performed, which are pooled, clarified and concentrated. The virus suspension is treated with protamine sulfate to remove contaminating DNA and proteins. The resulting partially purified virus is processed through a sucrose density gradient centrifugation step and fractionated. Each fraction is analyzed for the presence of virus, and fractions with the highest virus activity are pooled to give a purified virus suspension. The purified virus is then inactivated by treatment with formaldehyde. The preparation is adjusted to a specified protein concentration and formulated by addition of aluminum hydroxide.

The formulated bulk vaccine is filled into syringes, at a volume of 0.5 mL per syringe. From the manufacturing process, IXIARO (japanese encephalitis vaccine) also contains: formaldehyde (not more than 200 ppm), bovine serum albumin (not more than 100 ng/mL), host cell DNA (not more than 200 pg/mL), sodium metabisulphite (not more than 200 ppm), host cell proteins (not more than 300 ng/mL), and protamine sulfate (not more than 1μg/mL). No preservatives, stabilizers, or antibiotics are added to the formulation.

Last reviewed on RxList: 3/11/2010
This monograph has been modified to include the generic and brand name in many instances.

IXIARO
(japanese encephalitis vaccine, inactivated, adsorbed) Suspension for Intramuscular Injection

DRUG DESCRIPTION

IXIARO, Japanese Encephalitis Vaccine, Inactivated, Adsorbed is a sterile suspension for intramuscular injection. Each dose of vaccine contains approximately 6 mcg of purified, inactivated JEV proteins and 250 mcg of aluminum hydroxide. The appearance of the liquid is a white, opaque, non-uniform suspension which becomes homogeneous upon shaking. As IXIARO (japanese encephalitis vaccine) is inactivated, it cannot cause Japanese Encephalitis.

IXIARO (japanese encephalitis vaccine) is a vaccine prepared by propagating JEV strain SA14-14-2 in Vero cells. Multiple viral harvests are performed, which are pooled, clarified and concentrated. The virus suspension is treated with protamine sulfate to remove contaminating DNA and proteins. The resulting partially purified virus is processed through a sucrose density gradient centrifugation step and fractionated. Each fraction is analyzed for the presence of virus, and fractions with the highest virus activity are pooled to give a purified virus suspension. The purified virus is then inactivated by treatment with formaldehyde. The preparation is adjusted to a specified protein concentration and formulated by addition of aluminum hydroxide.

The formulated bulk vaccine is filled into syringes, at a volume of 0.5 mL per syringe. From the manufacturing process, IXIARO (japanese encephalitis vaccine) also contains: formaldehyde (not more than 200 ppm), bovine serum albumin (not more than 100 ng/mL), host cell DNA (not more than 200 pg/mL), sodium metabisulphite (not more than 200 ppm), host cell proteins (not more than 300 ng/mL), and protamine sulfate (not more than 1μg/mL). No preservatives, stabilizers, or antibiotics are added to the formulation.

Last reviewed on RxList: 3/11/2010
This monograph has been modified to include the generic and brand name in many instances.

IXIARO
(japanese encephalitis vaccine, inactivated, adsorbed) Suspension for Intramuscular Injection

DRUG DESCRIPTION

IXIARO, Japanese Encephalitis Vaccine, Inactivated, Adsorbed is a sterile suspension for intramuscular injection. Each dose of vaccine contains approximately 6 mcg of purified, inactivated JEV proteins and 250 mcg of aluminum hydroxide. The appearance of the liquid is a white, opaque, non-uniform suspension which becomes homogeneous upon shaking. As IXIARO (japanese encephalitis vaccine) is inactivated, it cannot cause Japanese Encephalitis.

IXIARO (japanese encephalitis vaccine) is a vaccine prepared by propagating JEV strain SA14-14-2 in Vero cells. Multiple viral harvests are performed, which are pooled, clarified and concentrated. The virus suspension is treated with protamine sulfate to remove contaminating DNA and proteins. The resulting partially purified virus is processed through a sucrose density gradient centrifugation step and fractionated. Each fraction is analyzed for the presence of virus, and fractions with the highest virus activity are pooled to give a purified virus suspension. The purified virus is then inactivated by treatment with formaldehyde. The preparation is adjusted to a specified protein concentration and formulated by addition of aluminum hydroxide.

The formulated bulk vaccine is filled into syringes, at a volume of 0.5 mL per syringe. From the manufacturing process, IXIARO (japanese encephalitis vaccine) also contains: formaldehyde (not more than 200 ppm), bovine serum albumin (not more than 100 ng/mL), host cell DNA (not more than 200 pg/mL), sodium metabisulphite (not more than 200 ppm), host cell proteins (not more than 300 ng/mL), and protamine sulfate (not more than 1μg/mL). No preservatives, stabilizers, or antibiotics are added to the formulation.

Last reviewed on RxList: 3/11/2010
This monograph has been modified to include the generic and brand name in many instances.

Ixiaro Patient Information Including Side Effects

Brand Names: Ixiaro

Generic Name: Japanese encephalitis virus vaccine (SA14-14-2) (Pronunciation: Ixiaro)

What is Japanese encephalitis virus vaccine (SA14-14-2) (Ixiaro)?

Japanese encephalitis is a serious disease caused by a virus. It is the leading cause of viral encephalitis (inflammation of the brain) in Asia. Encephalitis is an infection of the membrane around the brain and spinal cord. This infection often causes only mild symptoms, but prolonged swelling of the brain can cause permanent brain damage or death.

Japanese encephalitis virus is carried and spread by mosquitos.

The Japanese encephalitis SA14-14-2 vaccine is used to help prevent this disease in adults and adolescents who are at least 17 years old.

This vaccine works by exposing you to a small dose of the virus, 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.

This vaccine is recommended for people who live in or travel to areas where Japanese encephalitis is known to exist, or where an epidemic has recently occurred.

You should receive the vaccine and booster dose at least 1 week prior to your arrival in an area where you may be exposed to the virus.

Not everyone who travels to Asia needs to receive a Japanese encephalitis vaccine. Follow your doctor instructions or the recommendations of the Centers for Disease Control and Prevention (CDC).

This vaccine is also recommended for people who work in a research laboratory and may be exposed to Japanese encephalitis virus through needle-stick accidents or inhalation of viral droplets in the air.

Like any vaccine, the Japanese encephalitis SA14-14-2 vaccine may not provide protection from disease in every person.

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

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 shots caused any side effects.

Becoming infected with Japanese encephalitis is much more dangerous to your health than receiving the vaccine to protect against it. 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; dizziness, weakness, fast heart rate; swelling of your face, lips, tongue, or throat.

Less serious side may include:

  • headache, tired feeling;
  • muscle pain, back pain;
  • low fever, chills, flu symptoms;
  • cold symptoms such as stuffy nose, sneezing, sore throat, cough;
  • mild itching or skin rash.
  • nausea, diarrhea; or
  • pain, redness, tenderness, or a hard lump where the shot was given.

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 side effects to FDA at 1-800-FDA-1088.

Read the Ixiaro (japanese encephalitis vaccine) Side Effects Center for a complete guide to possible side effects »

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

The Japanese encephalitis SA14-14-2 vaccine is given in a series of 2 shots. The shots are usually 28 days apart. Your individual booster 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.

Japanese encephalitis SA14-14-2 vaccine is for use in adults and adolescents who are at least 17 years old.

This vaccine is recommended for people who live in or travel to areas where Japanese encephalitis is known to exist, or where an epidemic has recently occurred.

You should receive the vaccine and booster dose at least 1 week prior to your arrival in an area where you may be exposed to the virus.

This vaccine is also recommended for people who work in a research laboratory and may be exposed to Japanese encephalitis virus through needle-stick accidents or inhalation of viral droplets in the air.

Becoming infected with Japanese encephalitis is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Side Effects Centers

Ixiaro Patient Information including How Should I Take

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

You should not receive this vaccine if you have ever had a life-threatening allergic reaction to a Japanese encephalitis vaccine.

Before receiving this vaccine, tell the doctor if you are allergic to any foods or drugs, or if you have:

  • a bleeding or blood clotting disorder;
  • a weak immune system caused by disease such as HIV or AIDS, bone marrow transplant, or by using certain medicines or receiving cancer treatments.

You can still receive a vaccine if you have a cold or low fever. In the case of a more severe illness with a high fever (more than 100 degrees) or any type of infection, wait until you get better before receiving this vaccine.

Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with the Japanese encephalitis virus.

It is not known whether Japanese encephalitis 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.

How is this vaccine given (Ixiaro)?

This vaccine is given as an injection (shot) into a muscle of your upper arm. You will receive this injection in a doctor's office or other clinic setting.

The Japanese encephalitis SA14-14-2 vaccine is given in a series of 2 shots. The shots are usually 28 days apart. Your individual booster 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.

In addition to receiving the Japanese encephalitis vaccine, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could infect you with the Japanese encephalitis virus.

Side Effects Centers

Ixiaro Patient Information including If I Miss a Dose

What happens if I miss a dose (Ixiaro)?

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 you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

What happens if I overdose (Ixiaro)?

An overdose of this vaccine is unlikely to occur.

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

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

What other drugs will affect Japanese encephalitis virus vaccine (SA14-14-2) (Ixiaro)?

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), 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).

This list is not complete and there may be other drugs that can affect Japanese encephalitis vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using 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.

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Side Effects Centers

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