Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

Phase 3

Completed

• Conditions: Japanese Encephalitis
• Interventions: Biological: IC51

• 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.

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-04
• Study Completion: 2007-09
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-16
• Results First Submitted: 2013-12-05
• Results First Submitted QC: 2013-12-05
• Results First Posted: 2014-01-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

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

Arm && Interventions

Group	Intervention	Description
IC51 Group C	IC51	IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
IC51 Group A	IC51	IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
IC51 Group B	IC51	IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches

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