CTRI/2017/01/007706已完成3 期
A Phase-III multicentric randomized open label, active Controlled study to evaluate the Immunogenicity and Safety of BBILs combination of DTwPHib (Comvac4) vaccine in comparison with Reference Vaccine Comvac3â?¢ BioHib in healthy infants of 6 to 7 weeks age - Comvac4
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Parent/guardian of subject willing to give written informed consent and to comply with all study related procedures and visits
- •2.Healthy male or female infants aged 6 â?? 7 weeks at the time of screening/enrolment.
- •3.Subjects who are healthy without any history of DTP and Hib vaccination
- •4.Infants received EPI vaccines at birth (i.e., OPV, BCG and/or Hep B) as well IPV
- •5.Subjects should have been born after 36-week term and are not less than >=4.00kg, at the time of inclusion
排除标准
- •1.Infants aged less than 6 weeks or more than 7 weeks at the time of screening/enrolment.
- •2.Fever of any origin of duration more than 3 days prior to/at screening visit.
- •3.Past history of DTP &Hib vaccination.
- •4.History of acute or chronic auto immune disease
- •5.Any confirmed or suspected immunosuppressive condition.
- •6.Any treatment with immunosuppressive or immunostimulant therapy
- •7.Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for DTP and Hib.
- •8.Known hypersensitivity reactions to any of the components of the vaccine.
- •9.Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
研究者
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