Safety Surveillance After Immunization With IXIARO

Completed

• Conditions: Japanese Encephalitis
• Interventions: Biological: Japanese Encephalitis Virus vaccine, inactivated, adsorbed

• Registration Number: NCT01335412
• Lead Sponsor: Valneva Austria GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-13
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IXIARO exposed group	Japanese Encephalitis Virus vaccine, inactivated, adsorbed	Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of IXIARO

Primary Outcome Measures

Name	Time	Method
Incidence of pre-defined, serious adverse events	42 days after each dose of IXIARO

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Military Vaccine Agency; 🇺🇸 Alexandria, Virginia, United States