NCT00617812已完成4 期
An Open Label Multicentric Study to Evaluate the Immunogenicity and Safety of Indigenously Developed DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine (Shan 5) in Indian Infants.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine.
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) combination vaccine in healthy Indian infants as a part of the routine immunization in accordance with the EPI schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children in the age group six to eight weeks
- •Born after a normal gestational period (36 - 42 weeks)
- •Mother's HBsAg assured negative.
- •Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
- •Parents willing to fill the Diary Card
排除标准
- •Administration of immunoglobulin or any blood products since birth.
- •Use of any investigational, on-registered drug, or vaccine other than the study vaccine (with the exception of OPV & BCG vaccine) during the study period or within 30 days preceding the first dose of the study vaccine.
- •Previous vaccination or evidence of infection with DTP.
- •History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics.
- •Major congenital or hereditary immunodeficiency.
- •Infants having evidence of disease or fever, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination.
- •Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy and hypersensitivity reaction.
- •Parent/s or guardian of subject unable to maintain diary card
- •Simultaneous participation in any other clinical study
研究组 & 干预措施
Shan5
Experimental
干预措施: Shan5 (Biological)
结局指标
主要结局
Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine.
时间窗: 4 months
次要结局
- Solicited and unsolicited local and systemic adverse events following vaccination(4 months)
研究者
研究点 (4)
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