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Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines | Clinical Trials | Clareo Health

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Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

Lot-to-lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

NCT00735644•Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

Summary

This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months. Primary objective: To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur. Secondary objective: To describe the safety of vaccination in all subjects

Detailed Description

This is a Phase III trial in toddlers in Thailand and the Philippines.

Eligibility

Age

1 - 1 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Aged 12 to 18 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, and by at least one independent witness if required by local regulations.
•Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
•Completion of vaccinations according to the national immunization schedule.

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, 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 a vaccine containing any of the same substances.
•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.
•Administration of any anti-viral within 2 months preceding V01.
•History of central nervous system disorder or disease, including seizures.
•Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
•Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
+7 more criteria

Locations (8)

Alabang, Philippines

Bayanan, Philippines

Buli, Philippines

Cupang, Philippines

Sucat, Philippines

Bangkok, Thailand

Khon Kaen, Thailand

Key Dates

Start Date

August 1, 2008

Primary Completion Date

May 1, 2009

Completion Date

August 1, 2009

Last Updated

April 21, 2015

Enrollment

1,200

ACTUAL participants

Conditions

Japanese EncephalitisHepatitis A

Interventions

Japanese encephalitis vaccine

BIOLOGICAL

Japanese encephalitis vaccine

BIOLOGICAL

Japanese encephalitis vaccine

BIOLOGICAL

Japanese encephalitis vaccine (Acambis)

BIOLOGICAL

Hepatitis A vaccine

BIOLOGICAL

Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization

NCT06372665

Japanese Encephalitis

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NOT_YET_RECRUITING

Long-term Immunogenicity of L-HAV Vaccine Among Healthy Thai Children and Adolescents

NCT07032610

Hepatitis AHepatitis A Virus+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 21, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

Inclusion Criteria

Exclusion Criteria

Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization

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