CTRI/2016/07/007109已完成2 期
A Phase II/III randomised, comparative, multicentre Study to Evaluate the Safety and Immunogenicity of Biological Eâ??s Live, Attenuated Measles-Rubella Vaccine (MR) in 9-12 month old Healthy Infants. - None
Biological ELimited0 个研究点目标入组 600 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
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.Healthy male or female infants between 9-12 months of age at the time of first vaccination;
- •2.Infants free of obvious health problems as established by medical history and physical examination before entering the study.
- •3.Parent or LAR willing to provide written informed consent.
- •4.Willing to strictly follow the study protocol requirements.
排除标准
- •1.Serious adverse event to any earlier vaccinations, as respiratory difficulty, angioedema and anaphylaxis;
- •2.Family history of any hypersensitivity reactions to Measles, MR or MMR vaccination(s) or allergy to any of their components.
- •3.Acute or chronic illness or major congenital defects;
- •4.Exposure to measles and rubella <=30 days before study start;
- •5.Use of blood products within 3 months before the vaccination;
- •6.Use of any vaccine type within 30 days before the vaccination of the study;
- •7.Any confirmed or suspected condition wherein the child is immunocompromised or receiving immunosuppressive medication;
- •8.Use of any kind of investigational medication within 3 months before the study vaccination;
- •9.Coagulopathies diagnosed by a physician or report of capillary fragility (ex: bruises or bleedings without justifiable cause);
- •10.A history of neurologic disorders or seizures;
- •11.Any confirmed or suspected Infection with HIV, HCV and Hepatitis B (HBsAg).
- •12.Any criteria, which in the opinion of the Investigator, suggests that the child would not be compliant with the requirements of the study protocol.
研究者
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