A Phase IV, Open Label, Randomized, Parallel Group, Multicentre Clinical Study To Determine And Compare Reactogenicity Of Pentavac Vaccine (DTP-HB+Hib) of SIIL with Tritanrix-HB-HIB of GSK in Indian infants.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- Occurrence of solicited adverse reaction within 3 days of each vaccine dose.
研究概览
简要总结
1500 subjects will be screened for eligibility criteria after written informed consent from their parents/guardian. Eligible subjects will be randomized (2:1) to receive either 0.5 ml of Pentavac vaccine of SIIL or Tritanrix-HB-Hib of GSK. Study vaccine will be administered deep intramuscularly in the right anterolateral thigh. At first 3 visits (6, 10, and 14 weeks of age), the study vaccines will be administered. The parents/Legal Guardian will be informed to visit the study centre on 28th day (2nd visit), 56th day (3rd visit) and 84th day (4th visit). At each visit, the subjects will be physically examined and parents will be asked for adverse events and concomitant medication. Diaries will be collected and transcribed into Case Record Form. The study is planned in Indian Infants only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
入选标准
- •Normal healthy infants of age 6-8 weeks at the time of the first vaccination2)Parents/Legal Guardian of subject willing to give written informed consent 3)Parents/Legal Guardian willing to comply with study protocol.4)Free of obvious health problems as established by medical history and screening evaluation including clinical examination.5)The participant should be the resident of study area.
排除标准
- •Infant subject participating in other clinical trial or planned participation in another clinical trial 2) Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy 3)Infant with history of allergy or systemic hypersensitivity to any of the vaccine component 4)Infant with chronic illness.
- •Infant who receive blood or blood?derived products in the past.
- •Known history of a bleeding disorder.
- •History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.
结局指标
主要结局
Occurrence of solicited adverse reaction within 3 days of each vaccine dose.
时间窗: within 3 days of each vaccine dose.
次要结局
- 1)Occurrence of unsolicited adverse events(within 28 days following the administration of each vaccine dose.)