Safety Surveillance After Immunization With IXIARO

Japanese Encephalitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335412
• Other study ID #: IC51-401
• Status: Completed
• Phase: N/A
• First received: April 13, 2011
• Last updated: March 9, 2015
• Start date: March 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2015
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20000
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

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)

Locations

Country	Name	City	State
United States	Military Vaccine Agency	Alexandria	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pre-defined, serious adverse events		42 days after each dose of IXIARO	Yes
Secondary	Detection of non-predefined Adverse Events overrepresented after IXIARO	Data-mining for overrepresented Adverse events in the IXIARO exposed group compared to comparison group	42 days after each dose of IXIARO	Yes
Secondary	Occurrence of complications during pregnancy	Detect and describe pregnancy complications following inadvertent vaccination in pregnant women	Up to delivery	Yes
Secondary	Occurrance of infant health complications	Detect and describe infant health complications following inadvertent vaccination in pregnant women	up to 3 months after birth	Yes