Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

NCT ID: NCT00594958

Last Updated: 2024-03-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

639 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Japanese Encephalitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IC51 Group A

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

Group Type ACTIVE_COMPARATOR

IC51

Intervention Type BIOLOGICAL

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

IC51 Group B

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

Group Type ACTIVE_COMPARATOR

IC51

Intervention Type BIOLOGICAL

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

IC51 Group C

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

Group Type ACTIVE_COMPARATOR

IC51

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IC51

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

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Japanese Encephalitis purified inactivated vaccine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test

Exclusion Criteria

* History of immunodeficiency or immunosuppressive therapy, known HIV, drug addiction including alcohol dependence
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Valneva Austria GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susanne Eder, Mag.

Role: STUDY_DIRECTOR

Valneva Austria GmbH

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IC51-309

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.