Immunogenicity and Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE CV) Concomitantly Administered With Measles, Mumps, and Rubella (MMR) Vaccine in Toddlers in Taiwan.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 542
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination
研究概览
简要总结
This study is designed to compare the immunogenicity of Japanese encephalitis chimeric virus vaccine (JE-CV) and measles-mumps-rubella (MMR)vaccine when given together or when given at separate visits 6 weeks apart in toddlers aged 12 to 18 months.
Primary objective:
- To demonstrate the non-inferiority of the antibody responses in terms of seroconversion of the concomitant administration of JE-CV and MMR compared to the antibody responses after the single administration of JE-CV and MMR vaccine.
Secondary objectives:
- To describe the immune response to JE CV and MMR before and after one dose of JE CV and MMR vaccine, respectively.
- To describe the safety of a single dose of JE-CV and MMR vaccine (given separately at a 6-week interval and the safety of the concomitant administration of JE-CV and MMR vaccine in all subjects up to 6 months after last vaccination.
详细描述
All participants will receive Japanese encephalitis chimeric virus vaccine and measles-mumps-rubella vaccine and will be monitored for safety throughout the study.
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
- None
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 .
- •Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg.
- •Subject in good health based on medical history and physical examination.
- •Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by an independent witness if the parents or legally acceptable representative cannot read.
- •Subject and parent/legally acceptable representative or delegate able to attend all scheduled visits and comply with all trial procedures.
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 first trial vaccination.
- •Planned participation in another clinical trial during the present trial period.
- •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination except for pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.
- •Planned receipt of any vaccine up to the 6 weeks following the last trial vaccination except for pandemic influenza vaccine. In the event of a local or national immunization program with a pandemic influenza vaccine, participants who receive a pandemic influenza vaccine at any time during the trial will not be withdrawn from the trial.
- •Previous vaccination against measles, measles-mumps-rubella (MMR), or flavivirus disease, including Japanese encephalitis (JE).
- •Receipt of blood in the past 6 months that might interfere with the assessment of the immune response
- •Receipt of intravenous injection of plasma, platelet product, or high dose of intravenous immunoglobulin in the past 11 months
- •Receipt of intramuscular treatment of immunoglobulin or Hepatitis B immunoglobulin in the past 3 months
- •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 history of human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C seropositivity.
- •History of measles, mumps, rubella, or flavivirus infection confirmed either clinically, serologically, or microbiologically.
- •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 .
- •Known systemic hypersensitivity to gelatin, eggs, or anaphylactic/anaphylactoid reaction to neomycin.
- •Known history of thrombocytopenia.
- •Administration of any anti-viral within 2 months preceding first vaccination and up to the 6 weeks following the last trial vaccination.
- •History of central nervous system disorder or disease, including seizures and febrile seizures.
- •Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
研究组 & 干预措施
Group 1
Participants will receive the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 0 and Measles, mumps, and rubella live attenuated virus vaccine (MMR) on Day 42
干预措施: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus (Biological)
Group 2
Participants will receive Measles, mumps, and rubella live attenuated virus vaccine (MMR) on Day 0, and the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 42.
干预措施: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus (Biological)
Group 3
Participants will receive the Measles, mumps, and rubella live attenuated virus vaccine (MMR) and the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 0
干预措施: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus (Biological)
结局指标
主要结局
Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination
时间窗: Day 0 (pre-vaccination) and Day 42 post-vaccination
JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer \<1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is \<120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is \<10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is \<10 U/ml.
次要结局
- Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine(Pre-vaccination and up to Month 12 post-vaccination)
- Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine(Pre-vaccination and Day 42 post-vaccination)
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine(Day 0 up to Day 14 post-vaccination)
- Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine(Pre-vaccination and Day 42 post-vaccination)
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine(Day 0 up to Day14 post-vaccination)