A clinical study to assess protection against Rubella and also to assess the safety and immunogenicity of rubella vaccine in teenaged girls in Maharashtra
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2008/091/000100
- Lead Sponsor
- Serum Institute of India Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1200
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serosurveillance of IgG Rubella antibodies in teenaged girls.Timepoint: Antibody level assessment done at pre-vaccination.
- Secondary Outcome Measures
Name Time Method Immunogenicity and reactogenicity assessment of Rubella vaccine.Timepoint: Immunogenicity assessment at pre-vaccination and six weeks post-vaccination. Reactogenicity assessment upto six weeks post-vaccination.