Japanese Encephalitis
Conditions
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.
Interventions
BIOLOGICALJapanese 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)
Sponsors
Valneva Austria GmbH
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of pre-defined, serious adverse events | 42 days after each dose of IXIARO |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of non-predefined Adverse Events overrepresented after IXIARO | 42 days after each dose of IXIARO | Data-mining for overrepresented Adverse events in the IXIARO exposed group compared to comparison group |
| Occurrence of complications during pregnancy | Up to delivery | Detect and describe pregnancy complications following inadvertent vaccination in pregnant women |
| Occurrance of infant health complications | up to 3 months after birth | Detect and describe infant health complications following inadvertent vaccination in pregnant women |
Countries
United States
Outcome results
None listed