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Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea

Sponsored by Sanofi Pasteur, a Sanofi Company

About this trial

Last updated 3 years ago

Study ID

JEC22

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
2 to 4 Years
All
All

Trial Timing

Ended 11 years ago

What is this trial about?

The aim of this study was to document the immunogenicity and safety of a booster dose of IMOJEV administered at least 12 months after the primary dose. Primary objective: - To describe the immune response to Japanese Encephalitis (JE) before and 28 days after a booster dose of IMOJEV administered at least 12 months after primary vaccination with IMOJEV. Exploratory objectives: - To describe the safety profile of a booster dose of IMOJEV® .

What are the participation requirements?

Yes

Inclusion Criteria

- Must have participated in study JEC12 and received 1 dose of IMOJEV at least 12 months before booster vaccination

- Age 2 to 4 years on the day of inclusion

- In good general health at the time of inclusion

- Informed Concent Form signed and dated by parent(s) or another legally acceptable representative(s)

- Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and comply with all study procedures.

No

Exclusion Criteria

- Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the study vaccination

- 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 the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances

- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

- Receipt of immune globulins, 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 JE, with another vaccine, except with IMOJEV® while participating in JEC12

- Administration of any anti-viral within 2 months preceding Visit 1 and up to the 4 weeks following the study vaccination

- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination, except for inactivated influenza vaccination, which may be received at least 2 weeks before the study vaccine

- 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 2 consecutive weeks within the 4 weeks preceding vaccination

- Thrombocytopenia, contraindicating vaccination

- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating 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. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided

- In an emergency setting or hospitalized involuntarily

- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.

Locations

Location

Status