Sero-surveillance to assess rubella susceptibility including assessment of immunogenicity and safety of Rubella vaccine in females aged 18-24 years.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2011/091/000099
- Lead Sponsor
- Serum Institute of India Research Foundation Pune Hadapsar Pune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
1. Female students aged 18-24 years at the time of enrollment.
2. Free of obvious health problems as established by medical history & clinical examination
before entering into the study.
3. Written, Explained, Signed informed consent.
1. Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period.
2. Administration of immunoglobulin or any blood products in last 3 months.
3. History of significant and persistent hematological, hepatic, renal, cardiac, respiratory,
neurological disorders or seizure.
4. Axillary temperature ≥ 38.5 ° C.
5. Confirmed immunosuppression including HIV infection.
6. Major congenital or hereditary immunodeficiency.
7. Simultaneous participation in any other clinical study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the proportion of females not having protective <br/ ><br>serum antibody titres against Rubella. <br/ ><br>Timepoint: Blood Sample to be drawn at the time of enrollment (pre-immunization).
- Secondary Outcome Measures
Name Time Method 1. Rubella antibody titre 4-6 weeks after vaccination. <br/ ><br>2. Clinical tolerability of the vaccine.Timepoint: 1. Blood Sample to be drawn 4-6 weeks after vaccination (post-immunization). <br/ ><br>2. Safety asessment done until 4- 6 weeks following vaccination.