Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
Phase 3
Completed
- Conditions
- Japanese Encephalitis
- Registration Number
- NCT00594958
- Lead Sponsor
- Valneva Austria GmbH
- Brief Summary
The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 639
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method GMT for Anti-JEV Neutralizing Antibody day 56 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.
- Secondary Outcome Measures
Name Time Method SCR for Anti-JEC Neutralizing Antibody Titer day 56 Safety study duration Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability