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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Japanese Encephalitis

Japanese Encephalitis Virus Disease

Treatments

Biological: Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)

Biological: Live attenuated Japanese encephalitis chimeric virus vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01396512

JEC12

U1111-1117-7378 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

274 patients

Sex

All

Ages

12 to 24 months old

Volunteers

Accepts Healthy Volunteers

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.