Safety Surveillance After Immunization With IXIARO

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.

Study Overview

• Status: Completed
• Conditions: Japanese Encephalitis
• Intervention / Treatment: Biological: Japanese Encephalitis Virus vaccine, inactivated, adsorbed

• Study Type: Observational
• Enrollment (Actual): 20000

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Alexandria, Virginia, United States, 22312
      • Military Vaccine Agency

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Active duty military personnel (Army, Navy, Air Force, and Marines) who are ≥17 years of age and received at least one dose of Japanese encephalitis vaccine.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IXIARO exposed group; Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of IXIARO	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); Other Names: IXIARO
Comparison group; Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of JE-VAX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of pre-defined, serious adverse events	42 days after each dose of IXIARO

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Occurrence of complications during pregnancy	Detect and describe pregnancy complications following inadvertent vaccination in pregnant women	Up to delivery
Occurrance of infant health complications	Detect and describe infant health complications following inadvertent vaccination in pregnant women	up to 3 months after birth

Collaborators and Investigators

• Sponsor: Valneva Austria GmbH
• Investigators: Study Director: Katrin L Dubischar-Kastner, MSc, Valneva Austria GmbH

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 13, 2011
• First Submitted That Met QC Criteria: April 13, 2011
• First Posted (Estimate): April 14, 2011

Study Record Updates

• Last Update Posted (Estimate): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Encephalitis, Japanese; Encephalitis
• Other Study ID Numbers: IC51-401