A Phase IV, Non-Inferiority, Observer Blind Randomized Clinical Study Comparing Safety And Immunogenicity Of MMR Subcutaneous Vaccination By Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe For The Administration In Healthy Children In India Aged 15 To 18 Months
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 341
- 试验地点
- 12
- 主要终点
- Seropositivity of individual child for measles, mumps and rubella
研究概览
简要总结
This is a study planned to determine and compare immunogenicity and reactogenicity of MMR vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 15 to 18 months.
详细描述
This is a randomized, observer blind, non-inferior, parallel group, multi-centre clinical study to determine and compare immunogenicity and reactogenicity of MMR vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 15 to 18 months. Sera samples will be analyzed by ELISA for seroconversion / seropositivity for each individual component of vaccine i.e. measles, mumps and rubella at 35 days after administration of a single dose of MMR vaccine of Serum Institute of India.
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
- 15 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal healthy infants of age 15-18 months at the time of the screening and have not received their first dose of MMR vaccine.
- •Previously received a measles monovalent vaccine at 9 months, as confirmed by the childhood vaccination record.
- •Parents or legal guardians of subject willing to give written informed consent and willing to comply with study protocol.
- •Free of obvious health problems as established by medical history and screening evaluation including clinical examination.
排除标准
- •Infant subject participating in other clinical trial or planned participation in another clinical trial during the present trial period
- •Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy.
- •Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or to a vaccine containing the same substances.
- •Infant with history of epilepsy or a seizure disorder or neurodevelopmental disorders.
- •Clinical history of measles, mumps, or rubella infection.
- •Infants with leukemia, lymphoma, or any other cancer or neoplasm.
- •Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, neurological, cardiovascular, metabolic, hepatic or renal functional abnormality, as determined by medical history, and physical examination tests, which in the opinion of the investigator, might interfere with the study objectives
- •Infant with any other condition, which, in the opinion of the investigator would jeopardize the safety or rights of the infant participating in the study or making it unlikely the subject could complete the protocol.
研究组 & 干预措施
Disposable syringe jet injector
Subjects in this arm will be given a single subcutaneous 0.5 mL dose of Serum Institute of India Ltd.'s MMR vaccine (Brand name: Tresivac) via Disposable Syringe Jet Injector (Brand Name:Stratis) of Pharmajet Inc.
干预措施: MMR vaccine (Biological)
Needle-Syringe
Subjects in this arm will be given a single subcutaneous 0.5 mL dose of Serum Institute of India Ltd.'s MMR vaccine (Brand name: Tresivac) via conventional needle and Syringe
干预措施: MMR vaccine (Biological)
结局指标
主要结局
Seropositivity of individual child for measles, mumps and rubella
时间窗: 35 days after administration of the study vaccines
Seropositivity of the individual child for particular vaccine component will be defined according to the levels given in the kit literature.
次要结局
- Comparison of Geometric Mean titers (GMTs) for anti-measles, anti-mumps and anti-rubella antibodies(Day 35)
- Serious adverse events (SAEs)(Day 35)
- Solicited adverse reactions(Day 14)
- Unsolicited adverse events(Day 35)