Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

Sanofi

Status and phase: Completed; Phase 2

Conditions: Japanese Encephalitis; Hepatitis A

Treatments: Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28); Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00621764

JEC01

Details and patient eligibility

About

Safety:

To describe the safety profiles following vaccination.

Immunogenicity:

To describe the immune response after a single dose of vaccine.

Full description

This is a randomized, cross-over, open, active controlled, multi-center trial in toddlers and children in Thailand. Stepwise enrollment of children in 2 age cohorts. Subjects will be followed for 5 years.

Enrollment: 300 patients

Sex: All

Ages: 12 months to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of consent form signed by at least one parent or another legally acceptable representative, and by at least one independent witness.
• Completion of vaccinations according to the national immunization schedule
• Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
• Previous receipt of two doses of a mouse-brain-derived JE vaccine at 12 to 15 months of age according to the national immunization schedule and aged 2 to 5 years on the day of inclusion.
• Aged 12 to 24 months on the day of inclusion and have not received any JE vaccine.

Exclusion criteria

• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
• 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 the trial vaccine or 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.
• Receipt of hepatitis A vaccine.
• History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
• Administration of any anti-viral within 2 months preceding the screening visit.
• History of central nervous system disorder or disease.
• Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
• Planned participation in another clinical trial during the present trial period.
• 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, hepatitis B or hepatitis C seropositivity in the blood sample taken at screening.
• Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination.
• Previous vaccination against flavivirus disease at any time before the trial other than a mouse-brain-derived JE vaccine given in a two-dose regimen at 12 to 15 months of age in accordance with the national immunization schedule.
• Febrile illness or any acute illness/infection on the day of vaccination, according to investigator judgment
• History of seizures.
• Previous vaccination against flavivirus disease.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

JE-CV/Hepatitis A (Group 1)

Experimental group

Description:

Participants aged 2 to 5 years at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28)

Treatment:

Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)

Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)

Hepatitis A/JE-CV (Group 2)

Experimental group

Description:

Participants aged 2 to 5 years at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28)

Treatment:

Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)

Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)

JE-CV/Hepatitis A (Group 3)

Experimental group

Description:

Participants aged 12 to 24 months at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28)

Treatment:

Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)

Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)

Hepatitis A/JE-CV (Group 4)

Experimental group

Description:

Participants aged 12 to 24 months at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28)

Treatment:

Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)

Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)