Safety Surveillance After Immunization With IXIARO

Valneva Austria GmbH20,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

20,000

Conditions

Japanese Encephalitis

Interventions

Japanese Encephalitis Virus vaccine, inactivated, adsorbedBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Military Vaccine Agency

Alexandria, Virginia, United States

Outcomes

Primary Outcomes

Incidence of pre-defined, serious adverse events

Time frame: 42 days after each dose of IXIARO

Secondary Outcomes

Detection of non-predefined Adverse Events overrepresented after IXIARO

Data-mining for overrepresented Adverse events in the IXIARO exposed group compared to comparison group

Time frame: 42 days after each dose of IXIARO

Occurrence of complications during pregnancy

Detect and describe pregnancy complications following inadvertent vaccination in pregnant women

Time frame: Up to delivery

Occurrance of infant health complications

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

Time frame: up to 3 months after birth

Data from ClinicalTrials.gov

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