NCT01335412
Completed
Not Applicable
Active Surveillance for Adverse Events After Immunization With IXIARO(R) Among U.S. Military Service Personnel
ConditionsJapanese Encephalitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Japanese Encephalitis
- Sponsor
- Valneva Austria GmbH
- Enrollment
- 20000
- Locations
- 1
- Primary Endpoint
- Incidence of pre-defined, serious adverse events
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Incidence of pre-defined, serious adverse events
Time Frame: 42 days after each dose of IXIARO
Secondary Outcomes
- Detection of non-predefined Adverse Events overrepresented after IXIARO(42 days after each dose of IXIARO)
- Occurrence of complications during pregnancy(Up to delivery)
- Occurrance of infant health complications(up to 3 months after birth)
Study Sites (1)
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