NCT00877357Unknown4 期
Open Label Multicentric Randomized Phase IV Post Marketing Safety, Immunogenicity and Lot-to-Lot Consistency Analysis of Shan 5 [DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine] in Indian Infants
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Solicited and unsolicited local and systemic adverse events following vaccination
研究概览
简要总结
A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.
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
- 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 (hepatitis B surface antigen) assured negative.
- •Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
排除标准
- •Administration of immunoglobulin or any blood products since birth.
- •Use of any investigational, un-registered drug, or vaccine other than the study vaccine (with the exception of oral polio vaccination 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 or Hib.
- •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 born to mothers known to be HIV positive.
- •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- •Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.40C, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy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
结局指标
主要结局
Solicited and unsolicited local and systemic adverse events following vaccination
时间窗: 4 Months
次要结局
- Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine(12 Months)
- Lot Consistency based on safety and Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine from each of the three lots(4 months)
研究者
研究点 (2)
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