Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

Valneva Austria GmbH639 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

639

Conditions

Japanese Encephalitis

Interventions

IC51BIOLOGICAL

6 mcg, intramuscularly \[i.m.\], 0.5 mL

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: day 56

Secondary Outcomes

Safety

Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability

Time frame: study duration

SCR for Anti-JEC Neutralizing Antibody Titer

Time frame: day 56

Data from ClinicalTrials.gov

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