Multicentric, Phase II/III clinical trial study for evaluation of safety and immunogenicity of Live Varicella vaccine (Oka Strain) versus reference vaccine in Indian children. - PROTOCOL STUDY NO BM/BIOPOX/CT/01

Biomed Private Limited0 个研究点目标入组 252 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Subject should be a healthy child as assessed by history, physical examination and clinical judgment of the investigator.
•2.Age of subject should be between one to twelve years.
•3.Subject should be of Indian origin and will remain in the study area for the length of the trial.
•4.Subject should give written inform consent.
•5.Subject should be aware of full information regarding the vaccine and clinical trial.

•1.History of chicken pox disease.
•2.Subject is suffering from fever, diarrhoea and sign of acute infection.
•3.Subject is having a history of vaccination with chicken pox vaccine.
•4.Subject is having a history of disease, drug intake (like anti-malarial, steroids, phenytoin, anti-inflammatory drugs or immunosuppressive drugs) in the past two weeks of proposed vaccination date.
•5.Subject is having a history of allergy or hypersensitivity to any component of the vaccine.
•6.Subject is having immunodeficiency or an auto-immune disease.
•7.Subject is having a history of adverse reactions during previous vaccination.
•8.Subject is participating in any other study at the same time or during the past three months.
•9.Subject is planning surgery during the study period.
•10.Subject is likely to move out of station during the study period.

发起方

Biomed Private Limited