CTRI/2016/11/007452尚未招募4 期
Evaluation of Immunogenicity, safety and breakthrough infection of 2-doses of Live Attenuated Varicella Vaccine in Indian Children: 12 months follow up study
Wockhardt Ltd0 个研究点目标入组 305 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 305
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.Subjects aged >= 12 months but <=12 years of either sex.
- •2.No clinical history of varicella (chicken pox) and herpes zoster natural infection in the past.
- •3.With an axillary temperature <=37.5°C at the time of vaccination
- •4.No varicella vaccination history previously.
- •5.Parent or the legal guardian of the subject should provide written informed consent.
- •6.Parent or the legal guardian of the subject should agree to comply with all trial related instructions (maintain diary card, attend follow up visits)
排除标准
- •1.Clinical history of varicella (chicken pox) and herpes zoster natural infection in the past.
- •2.History of household, playmate, school or daycare center exposure to varicella or herpes zoster in the previous 4 weeks prior to vaccination.
- •3.Presence of any person in close vicinity of the subject who is at high risk of developing varicella (like immunocompromised sibling)
- •4.Any established or clinically suspected immunosuppressive or immunocompromised disorder / state (congenital or acquired- drug induced, neoplastic, tuberculosis etc.)
- •5.Any subject who had received parenteral immunoglobulin or any immunosuppressive drugs in the last three months.
- •6.Any major congenital abnormality â?? cardiac, renal, neurological.
- •7.Any acute dermatological disease such as, allergy and bacterial/viral/ fungal infection.
- •8.History of encephalopathy, epilepsy and other nervous system disorders.
- •9.Participant on any dose of oral/parenteral steroids or inhalational steroids >800 mcg of beclomethasone (or its equivalent) in the last 3 months prior to vaccination.
- •10.History of any allergic diatheses and those with known hypersensitivity to vaccine or any of its components like gelatin, gentamicin / neomycin/ kanamycin etc.
- •11.Febrile (axillary temperature > 37.5°C) or any systemic illness at the time of vaccination.
- •12.History of administration of Varicella zoster immune globulin or any blood products in the previous 4 weeks.
- •13.Subject has received any live vaccine in the last 4 weeks or any killed vaccine in the last 4 weeks prior to this scheduled vaccination.
- •14.Subject scheduled to be administered a live vaccine in the next 4 weeks or any killed vaccine in the next 4 weeks.
- •15.Participation in any other interventional clinical trial.
- •16.Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.
研究者
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