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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Japanese Encephalitis

Hepatitis A

Treatments

Biological: Japanese encephalitis vaccine (Acambis)

Biological: Japanese encephalitis vaccine

Biological: Hepatitis A vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00735644

JEC02

Details and patient eligibility

About

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

Full description

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

Enrollment

1,200 patients

Sex

All

Ages

12 to 18 months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.
Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
Personal human immunodeficiency virus seropositivity in the blood sample taken at screening.
Receipt of any JE vaccine or hepatitis A vaccine.
Previous vaccination against flavivirus disease.
History of flavivirus infection (confirmed either clinically, serologically or microbiologically)
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination.
Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,200 participants in 5 patient groups

JE-CV GPO MBP (Lot 1)

Experimental group

Description:

Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1.

Treatment:

Biological: Japanese encephalitis vaccine

JE-CV GPO MBP (Lot 2)

Experimental group

Description:

Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 2.

Treatment:

Biological: Japanese encephalitis vaccine

JE-CV GPO MBP (Lot 3)

Experimental group

Description:

Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 3.

Treatment:

Biological: Japanese encephalitis vaccine

JE-CV WRAIR (Group 4)

Active Comparator group

Description:

Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)

Treatment:

Biological: Japanese encephalitis vaccine (Acambis)

Hepatitis A (Group 5)

Sham Comparator group

Description:

Participants 12 to 18 months of age randomized to receive Hepatitis A vaccine