CTRI/2013/05/003611已完成3 期
An Open label, Phase III, Multicentric Randomized controlled study to evaluate the safety and immunogenicity of Single dose Live Attenuated Varicella Vaccine (VR 795 varicella Oka strain) versus Varilrix Vaccine in healthy Indian children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 254
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
- •Healthy children aged 12 months to 12 years of either sex who are baseline VZV IgG antibody negative
- •Parent/guardian of subject willing to give written informed consent and to comply to all study related procedures
排除标准
- •Clinical history of varicella (chicken pox) and herpes zoster natural infection in the past.
- •History of Varicalla vaccination in the past.
- •History of household, playmate, school or daycare center exposure to varicella or herpes zoster in the previous 4 weeks prior to vaccination
- •Presence of any person in close vicinity of the vaccine who is at high risk of developing varicella (like immunocompromised sibling)
- •Any established or clinically suspected immunosuppressive or immunocompromised disorder / state (congenital or acquired- drug induced, neoplastic, tuberculosis etc)
- •Any subject who had received parenteral immunoglobulin or any immunosuppressive drugs in the last three months.
- •Any major congenital abnormality â?? cardiac, renal, neurological
- •Any acute dermatological disease such as, allergy and bacterial/viral/ fungal infection
- •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.
- •History of any allergic diatheses and those with known hypersensitivity to vaccine or any of its components like gelatin, gentamicin / neomycin/ kanamycin etc.
- •Febrile (axillary temperature > 37°C) or any systemic illness at the time of vaccination.
- •History of administration of varicella zoster immune globulin or any blood products in the previous 4 weeks
- •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.
- •Subject scheduled to be administered a live vaccine in the next 4 weeks or any killed vaccine in the next 4 weeks.
研究者
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