Clinical Study to assess the immune response and safety of Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Ltd. in healthy pediatric subjects aged 9-12 months
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2014/01/004343
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1.Healthy pediatric subjects of either sex aged 9 months to 12 months.
2.Informed consent of the parents/guardians and their willingness to be followed up for at least 6 weeks after vaccination of their child.
3.Parents/guardians with adequate literacy to fill the diary cards
1.Subjects with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to neomycin.
2.Subjects with a history of previous measles infection or measles vaccination or if they had been exposed to measles virus within 30 days of trial commencement.
3.A history of convulsions, epilepsy or other central nervous system diseases or an acute febrile illness at the time of planned vaccination.
4.Any other parenteral vaccine administration within 30 days of initiation of the study or during the study.
5.A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy).
6.Subjects who have received blood products or immunoglobulins parenterally during the preceding 3 months.
7.Subjects with any other clinically significant concurrent illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary immunogenicity criteria will be the <br/ ><br>seroconversion rate for measlesTimepoint: 42 days <br/ ><br>following <br/ ><br>vaccination
- Secondary Outcome Measures
Name Time Method The secondary immunogenicity criteria will be the postvaccination <br/ ><br>geometric mean titers (GMTs) of antibodies to <br/ ><br>measlesTimepoint: 42 days <br/ ><br>following <br/ ><br>vaccination