Safety Surveillance After Immunization With IXIARO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-06-30

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.

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Detailed Description

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Conditions

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Japanese Encephalitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IXIARO exposed group

Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of IXIARO

Japanese Encephalitis Virus vaccine, inactivated, adsorbed

Intervention Type BIOLOGICAL

2 x 6mcg / 0.5mL intramuscular injection, Day 0 and 28 (Primary series) or 1x 6mcg / 0.5mL intramuscular injection (Booster)

Comparison group

Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of JE-VAX

No interventions assigned to this group

Interventions

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Japanese Encephalitis Virus vaccine, inactivated, adsorbed

2 x 6mcg / 0.5mL intramuscular injection, Day 0 and 28 (Primary series) or 1x 6mcg / 0.5mL intramuscular injection (Booster)

Intervention Type BIOLOGICAL

Other Intervention Names

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IXIARO

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.

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No