Immunogenicity and Safety of a Single Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) in Comparison With a Single Dose of SA14-14-2 Vaccine (CD.JEVAX™, Chengdu Institute of Biological Products, China) Administered in Healthy Toddlers in South-Korea

Sanofi Pasteur, a Sanofi Company0 sites274 target enrollmentJuly 2011

ConditionsJapanese Encephalitis Japanese Encephalitis Virus Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Japanese Encephalitis
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 274
Primary Endpoint: Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine [CD.JEVAX™]) after a single dose vaccination to support product registration.

Primary Objective:

To demonstrate the non-inferiority of the antibody response 28 days after administration of one dose of IMOJEV™ compared to the antibody response 28 days after administration of one dose of the CD.JEVAX™ control vaccine.

Secondary Objectives:

To describe the immune response to Japanese encephalitis (JE) in both vaccine groups using 50% plaque reduction neutralization assay (PRNT50) assays before and after a single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine.
To describe the safety of vaccination in all subjects up to 28 days and all serious adverse events up to 6-month after vaccination.

Detailed Description

All participants will receive a single dose of their assigned vaccination at Visit 1 (Day 0) and undergo immunogenicity assessment at Day 28 post-vaccination. Safety will be assessed from day of vaccination and up to 6 months post-vaccination.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

June 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi Pasteur, a Sanofi Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 12 to 24 months on the day of inclusion
•In good general health, without significant medical history.
•Provision of informed consent form signed by at least one parent or other legally acceptable representative.
•Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.

Exclusion Criteria

•Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
•Planned participation in another clinical trial during the present trial period.
•Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
•Known systemic hypersensitivity to any of IMOJEV™ components or history of a life-threatening reaction to a vaccine containing any of the same substances and vaccination,known systemic hypersensitivity to CD.JEVAX® main components and the other components (including Gelatin, kanamycin, and gentamicin).
•Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
•Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
•Previous vaccination against flavivirus disease, including Japanese encephalitis (JE).
•Administration of any anti-viral within 2 months preceding Visit 01 and up to the 4 weeks following the trial vaccination.
•Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.
•Planned receipt of any vaccine from the inclusion up to the 4 weeks following the trial vaccination.

Outcomes

Primary Outcomes

Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine

Time Frame: Day 28 post-vaccination

Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (\<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.

Secondary Outcomes

Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine(Day 0 (pre-vaccination) and Day 28 post-vaccination)
Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine(Day 0 (pre-vaccination) and Day 28 post-vaccination)
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine(Day 0 up to Day 14 post-vaccination)