Safety Surveillance After Immunization With IXIARO

Completed

Conditions studied: Japanese Encephalitis

In brief

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.

Key facts

Study ID

NCT01335412

Run by

Valneva Austria GmbH

People needed

20000

Starts

2011-03-01

Expected to finish

2013-06-01

Last updated by the study team

2015-03-10

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Military Vaccine Agency — Alexandria, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.