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Clinical Trials/NCT00596102
NCT00596102
Completed
Not Applicable

Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51. An Uncontrolled Phase 3 Follow-up Study

Valneva Austria GmbH0 sites3,258 target enrollmentOctober 2005
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ConditionsJapanese Encephalitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Japanese Encephalitis
Sponsor
Valneva Austria GmbH
Enrollment
3258
Primary Endpoint
Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
March 2011
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Healthy subjects at least 18 years of age
  • •Written informed consent obtained prior to study entry
  • •Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination

Exclusion Criteria

  • •Inability or unwillingness to provide informed consent and to abide the requirements of the study

Outcomes

Primary Outcomes

Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)

Time Frame: 24 months after the first vaccination

first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302

Secondary Outcomes

  • Geometric Mean Titers(6, 12, 36, 48 and 60 months)
  • Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)(6, 12, 36, 48 and 60 months after 1st vaccination)
  • Adverse Events(6, 12, 24, 36, 48 and 60 months after 1st vaccination)

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