Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Japanese Encephalitis Japanese Encephalitis Virus Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IMOJEV™ Vaccine Group

Participants will receive a single dose of the Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV™) on Day 0.

Group Type EXPERIMENTAL

Live attenuated Japanese encephalitis chimeric virus vaccine

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous

CD.JEVAX ™ Vaccine Group

Participants will receive a single dose of the Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine), CD.JEVAX™ on Day 0

Group Type ACTIVE_COMPARATOR

Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous

Interventions

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Live attenuated Japanese encephalitis chimeric virus vaccine

0.5 mL, Subcutaneous

Intervention Type BIOLOGICAL

Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)

0.5 mL, Subcutaneous

Intervention Type BIOLOGICAL

Other Intervention Names

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IMOJEV™ CD.JEVAX™

Eligibility Criteria

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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.
* History of central nervous system disorder or disease, including seizures.
* Planned receipt of any JE vaccine during the course of the study.
* History of flavivirus infection (confirmed either clinically, serologically or virologically).
* Administration of systemic corticosteroids for more than two consecutive weeks within the 4 weeks preceding vaccination.
* Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection 3 days before vaccination as well as the day of vaccination, according to Investigator judgment.
* Thrombocytopenia or bleeding disorder contraindicated for vaccination with same administration route, or receipt of anticoagulants in the 3 weeks preceding inclusion.

Minimum Eligible Age

12 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes