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Safety Surveillance After Immunization With IXIARO

NCT01335412 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2015-03-10

No results posted yet for this study

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.

Conditions

  • Japanese Encephalitis

Interventions

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)

Sponsors & Collaborators

  • Valneva Austria GmbH

    lead INDUSTRY

Principal Investigators

  • Katrin L Dubischar-Kastner, MSc · Valneva Austria GmbH

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01335412 on ClinicalTrials.gov