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NCT00594958 Clinical Trial

Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

Japanese Encephalitis Clinical Trial

Official title:
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00594958
Other study ID # IC51-309
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2006
Est. completion date September 2007

Study information
Verified date March 2024
Source Valneva Austria GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.

Description:

This is a randomized, controlled, multi-center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years. 624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.

Recruitment information / eligibility
Status Completed
Enrollment 639
Est. completion date September 2007
Est. primary completion date April 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Main Inclusion Criteria: - Male and female subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test Main Exclusion Criteria: - History of immunodeficiency or immunosuppressive therapy, known HIV, drug addiction including alcohol dependence

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• IC51
6 mcg, intramuscularly [i.m.], 0.5 mL

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Valneva Austria GmbH

Outcome
Type Measure Description Time frame Safety issue
Primary GMT for Anti-JEV Neutralizing Antibody Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2. day 56
Secondary Safety Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability study duration
Secondary SCR for Anti-JEC Neutralizing Antibody Titer day 56
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