Safety Surveillance After Immunization With IXIARO

• Sponsor: Valneva Austria GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01335412
• Collaborator: (none)
• Enrollment: 20,000
• Location: 1
• Duration (Months): 27
• Patients Per Site Per Month: 739.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Japanese Encephalitis	Biological: Japanese Encephalitis Virus vaccine, inactivated, adsorbed

Study Design

• Study Type: Observational
• Actual Enrollment: 20000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Active Surveillance for Adverse Events After Immunization With IXIARO(R) Among U.S. Military Service Personnel
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Incidence of pre-defined, serious adverse events [42 days after each dose of IXIARO]

Secondary Outcome Measures

1. 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

2. Occurrence of complications during pregnancy [Up to delivery]

   Detect and describe pregnancy complications following inadvertent vaccination in pregnant women

3. Occurrance of infant health complications [up to 3 months after birth]

   Detect and describe infant health complications following inadvertent vaccination in pregnant women

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Military Vaccine Agency	Alexandria	Virginia	United States	22312

Sponsors and Collaborators

• Valneva Austria GmbH

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Valneva Austria GmbH
• ClinicalTrials.gov Identifier: NCT01335412
• Other Study ID Numbers: IC51-401
• First Posted: Apr 14, 2011
• Last Update Posted: Mar 10, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Encephalitis, Japanese; Encephalitis

Study Results

No Results Posted as of Mar 10, 2015