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

• Conditions: Japanese Encephalitis; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005193-38-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-17
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Provision of consent form signed by at least one parent or another legally acceptable representative, and by at least one independent witness.
2. Completion of vaccinations according to the national immunization schedule
3. Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
4. 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.
5. Aged 12 to 24 months on the day of inclusion and have not received any JE vaccine.
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
2. 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.
3. 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.
4. Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
5. Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
6. Receipt of hepatitis A vaccine.
7. History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
8. Administration of any anti-viral within 2 months preceding the screening visit.
9. History of central nervous system disorder or disease.
10. Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
11. Planned participation in another clinical trial during the present trial period.
12. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
13. Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
14. Personal human immunodeficiency virus, hepatitis B or hepatitis C seropositivity in the blood sample taken at screening.
15. Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination.
16. 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.
17. Febrile illness or any acute illness/infection on the day of vaccination, according to investigator judgment
History of seizures.
18. Previous vaccination against flavivirus disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified