Phase 3
Completed N=1,200
Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
Source: ClinicalTrials.gov NCT00735644 ↗Enrolled (actual)
1,200
Serious AEs
4.5%
Results posted
Aug 2014
Primary outcomePrimary: Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots — 0; 0; 0; 0 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots |
0; 0; 0; 0; NA; 282 | — |
| SECONDARY Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV |
5.17; 5.08; 5.19; 5.09; 212; 167 | — |
| SECONDARY Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV |
10; 4; 8; 2; NA; 297 | — |
| SECONDARY Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine |
41.1; 32.9; 36.6; 42.2; NA | — |
| SECONDARY Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. |
58; 59; 67; 59; 18; 0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00735644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.