Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

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

389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-06-30

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 commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

NCT00594958

Japanese Encephalitis

COMPLETED PHASE3

Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

NCT00604708

Japanese Encephalitis

COMPLETED PHASE3

Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling

NCT00776230

Japanese Encephalitis

COMPLETED PHASE3

Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

NCT00605085

Japanese Encephalitis

COMPLETED PHASE3

Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51

NCT00596102

Japanese Encephalitis

COMPLETED

Detailed Description

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

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 Batch A

Group Type ACTIVE_COMPARATOR

Japanese Encephalitis purified inactivated vaccine

Intervention Type BIOLOGICAL

IC51 6 mcg i.m. injection on Day 0 and Day 28

IC51 Batch B

Group Type ACTIVE_COMPARATOR

Japanese Encephalitis purified inactivated vaccine

Intervention Type BIOLOGICAL

IC51 6 mcg i.m. injection on Day 0 and Day 28

IC51 Batch C

Group Type ACTIVE_COMPARATOR

Japanese Encephalitis purified inactivated vaccine

Intervention Type BIOLOGICAL

IC51 6 mcg i.m. injection on Day 0 and Day 28

Interventions

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

Japanese Encephalitis purified inactivated vaccine

IC51 6 mcg i.m. injection on Day 0 and Day 28

Intervention Type BIOLOGICAL

Eligibility Criteria

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

Inclusion Criteria

* Male and female healthy adults 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 Human Immunodeficiency Virus (HIV); OR
* Drug addiction including alcohol dependence

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes