Lot-to-lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 8
- 主要终点
- Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots
研究概览
简要总结
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
详细描述
This is a Phase III trial in toddlers in Thailand and the Philippines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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 V
- •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.
研究组 & 干预措施
JE-CV WRAIR (Group 4)
Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
干预措施: Japanese encephalitis vaccine (Acambis) (Biological)
Hepatitis A (Group 5)
Participants 12 to 18 months of age randomized to receive Hepatitis A vaccine
干预措施: Hepatitis A vaccine (Biological)
JE-CV GPO MBP (Lot 3)
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.
干预措施: Japanese encephalitis vaccine (Biological)
JE-CV GPO MBP (Lot 2)
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.
干预措施: Japanese encephalitis vaccine (Biological)
JE-CV GPO MBP (Lot 1)
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.
干预措施: Japanese encephalitis vaccine (Biological)
结局指标
主要结局
Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots
时间窗: Day 0 (pre-vaccination) and Day 28 post-vaccination
Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer \<10 1/dil and post-vaccination titer ≥ 10 1/dil, or participants with pre-vaccination titer ≥ 10 1/dil and 4-fold increase from pre- to post-vaccination.
次要结局
- 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(Day 0 (pre-vaccination) and Day 28 post-vaccination)
- 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(Day 0 (pre-vaccination) and Day 28 post-vaccination)
- 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(Day 0 (pre-vaccination) and Day 28 post-vaccination)
- 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.(Day 0 up to Day 14 post-vaccination)