Safety Surveillance After Immunization With IXIARO

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT01335412
First received: April 13, 2011
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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 Intervention
Japanese Encephalitis
Biological: Japanese Encephalitis Virus vaccine, inactivated, adsorbed

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Active Surveillance for Adverse Events After Immunization With IXIARO(R) Among U.S. Military Service Personnel

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • Incidence of pre-defined, serious adverse events [ Time Frame: 42 days after each dose of IXIARO ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Detection of non-predefined Adverse Events overrepresented after IXIARO [ Time Frame: 42 days after each dose of IXIARO ] [ Designated as safety issue: Yes ]
    Data-mining for overrepresented Adverse events in the IXIARO exposed group compared to comparison group

  • Occurrence of complications during pregnancy [ Time Frame: Up to delivery ] [ Designated as safety issue: Yes ]
    Detect and describe pregnancy complications following inadvertent vaccination in pregnant women

  • Occurrance of infant health complications [ Time Frame: up to 3 months after birth ] [ Designated as safety issue: Yes ]
    Detect and describe infant health complications following inadvertent vaccination in pregnant women


Estimated Enrollment: 20000
Study Start Date: March 2011
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335412

Locations
United States, Virginia
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
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT01335412     History of Changes
Other Study ID Numbers: IC51-401
Study First Received: April 13, 2011
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 29, 2014