A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Japanese Encephalitis
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Enrollment
- 300
- Primary Endpoint
- Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Safety:
To describe the safety profiles following vaccination.
Immunogenicity:
To describe the immune response after a single dose of vaccine.
Detailed 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection
Time Frame: Day 0 up to Day 14 post-vaccination
12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, \>39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, \>3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, \>39˚C; Headache, Malaise, and Myalgia, Prevents activities.
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection
Time Frame: Day 0 up to Day 14 post-vaccination
12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, \>39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, \>3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, \>39˚C; Headache, Malaise, and Myalgia, Prevents activities.
Secondary Outcomes
- Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination(Day 0 (pre-vaccination) and Day 28 after final vaccination)
- Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination(Day 0 (pre-vaccination) and Day 28 after final vaccination)