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OpenTrials
Completed

NCT Number: NCT01335412

Safety Surveillance After Immunization With IXIARO

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.

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Key information

Conditions

Japanese Encephalitis Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Japanese Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Mosquito-Borne Diseases Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Military Vaccine Agency

Alexandria, Virginia, 22312, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Japanese Encephalitis Virus vaccine, inactivated, adsorbed

Biological

2 x 6mcg / 0.5mL intramuscular injection, Day 0 and 28 (Primary series) or 1x 6mcg / 0.5mL intramuscular injection (Booster)

Other names: IXIARO

Primary outcomes

  1. Incidence of pre-defined, serious adverse events

    Time frame: 42 days after each dose of IXIARO

Secondary outcomes

  1. Detection of non-predefined Adverse Events overrepresented after IXIARO

    Time frame: 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

    Time frame: Up to delivery

    Detect and describe pregnancy complications following inadvertent vaccination in pregnant women

  3. Occurrance of infant health complications

    Time frame: up to 3 months after birth

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

Sponsors and collaborators

Lead sponsor

Valneva Austria GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 14, 2011
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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