Safety Surveillance After Immunization With IXIARO

Study Overview
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Brief Summary
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This is an active electronic surveillance using data from the Defense Medical Surveillance System (DMSS) to detect and characterize serious, rare adverse events occurring within 42 days after vaccination with the Japanese Encephalitis Vaccine IXIARO within the US Military, to detect adverse events that occur more frequently after IXIARO and to electronically follow up pregnancies during or shortly before which IXIARO was administered. There will be no intervention and no individuals contacted.

Official Title
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Active Surveillance for Adverse Events After Immunization With IXIARO(R) Among U.S. Military Service Personnel

Conditions
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Japanese Encephalitis

Intervention / Treatment
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* Biological: Japanese Encephalitis Virus vaccine, inactivated, adsorbed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of IXIARO (IXIARO exposed group) or at least one dose of JE-VAX (comparison group). Exclusion Criteria: Individuals who have an ICD-9-CM code suggestive of one of the predefined adverse events screened for in IC51-401 prior to vaccination with IXIARO cannot with certainty be classified as being disease free at study entry and will be excluded for that adverse event.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IXIARO exposed group<br>Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of IXIARO | Biological: Japanese Encephalitis Virus vaccine, inactivated, adsorbed<br>* 2 x 6mcg / 0.5mL intramuscular injection, Day 0 and 28 (Primary series) or 1x 6mcg / 0.5mL intramuscular injection (Booster)<br>* Other names: IXIARO;|
| Comparison group<br>Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of JE-VAX | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pre-defined, serious adverse events |  | 42 days after each dose of IXIARO | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of non-predefined Adverse Events overrepresented after IXIARO | Data-mining for overrepresented Adverse events in the IXIARO exposed group compared to comparison group | 42 days after each dose of IXIARO | 
| Occurrence of complications during pregnancy | Detect and describe pregnancy complications following inadvertent vaccination in pregnant women | Up to delivery | 
| Occurrance of infant health complications | Detect and describe infant health complications following inadvertent vaccination in pregnant women | up to 3 months after birth |