Safety Surveillance After Immunization With IXIARO
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 17 - Any |
| Updated: | 11/30/2013 |
| Start Date: | March 2011 |
| Contact: | Katrin L Dubischar-Kastner, MSc |
| Email: | kdubischar-kastner@intercell.at |
| Phone: | +43 1 20620 |
Active Surveillance for Adverse Events After Immunization With IXIARO(R) Among U.S. Military Service Personnel
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.
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.
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