CTRI/2009/091/000616已完成4 期
A Phase IV, Open label, Randomised, Comparative, Parallel group, Clinical Study to Evaluate the immunogenicity and Safety of two different formulations of Haemophilus Influenzae Type-B Vaccine (SII HibPRO) of Serum Institute of India Limited in Indian Infants.
Serum Institute of India Ltd3 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2009年2月23日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 3
- 主要终点
- Immunogenicity- Long term seroprotection
研究概览
简要总结
The study is initiated after ethics committee approval from the respective study centers. Eligible subjects receive 0.5 ml of SII HibPRO vaccine of either formulation at 6, 10 and 14 weeks of age. The parents/legal guardians are informed to visit the study centre 1 month after each dose of study vaccine. At each visit, the subjects are physically examined and history is asked for adverse events (AE) and concomitants medications. 3 ml of blood is collected at baseline and at 1 month after the third dose. Serum samples will be tested for anti-PRP antibodies.
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
- 年龄范围
- 42.00 Day(s) 至 56.00 Day(s)（—）
- 性别
- All
入选标准
- •Normal healthy infants of age 6-8 weeks at the time of first vaccination 2) Parents of subject willing to give written informed consent 3) Free of obvious health problems as established by medical history and physical examination.
排除标准
- •Infant subject participating in other clinical trial.
- •Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy.
- •Infant with history of allergy or systemic hypersensitivity.
- •Infant with any chronic illness.
- •Infant who received blood or blood derived products in the past.
- •Known history of a bleeding disorder 7) Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the subject participating in the study or making it unlikely the subject could complete the protocol 8) History of febrile illness is a temporary exclusion criterion.
结局指标
主要结局
Immunogenicity- Long term seroprotection
时间窗: On day 0 and 84.
次要结局
- Safety: Occurrence of any solicited adverse reaction, unsolicited adverse event or any serious adverse event.Immunogenicity: Short term Seroprotection(Safety assessment on day 0, 28, 56 and 84.Immunogenicity assessment on day 0 and 84.)
研究者
研究点 (3)
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