NCT01335412

Safety Surveillance After Immunization With IXIARO

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	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)

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-04-14
• Last updated: 2015-03-10

Locations

1 site across 1 country: United States