Serosurvey to assess Rubella IgG antibodies in teenaged girls in Maharashtra and to assess immunogenicity and reactogenicity of Rubella vaccine (R-Vac).

Serum Institute of India Research Foundation0 个研究点目标入组 1,200 人开始时间: 待定最近更新: 2021年11月24日

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•Healthy Schoolgirls aged 12 ? 15 years at the time of enrollment. Free of obvious health problems as established by medical history & clinical examination before entering into the study. Written, Explained, Signed informed consent of the parents / guardian. No evidence of any acute severe infection or moderate to severe Fever. Available for an study related procedures i.e. prevaccination blood sample, vaccination and post vaccination blood sample.

•Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the study vaccine. History of receipt of Rubella containing vaccine/ History of confirmed rubella infection. Administration of immunoglobulin or any blood products in last 3 months. History of significant and persistent hematological, hepatic, renal, cardiac, respiratory, neurological disorders or seizure. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including allergy to NEOMYCIN or POLYMYXIN-B. Confirmed immunosuppression including HIV infection. Simultaneous participation in any other clinical study.

发起方

Serum Institute of India Research Foundation