A Phase III study to Evaluate the Non-interference in the Immune Response of Rotavac to Childhood Vaccines and to Assess the Clinical Lot Consistency.
Phase 3
Completed
- Registration Number
- CTRI/2014/05/004592
- Lead Sponsor
- Bharat Biotech International Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. At least one parent(s) consent for participation and are able to understand study procedures
2. Subjects aged 6 to 7 weeks (42 to 55 days) at recruitment
3. No plans to move in the next 4-6 months
Exclusion Criteria
1. Has already received the 6-7 week dose of the childhood vaccines
2. Administration of rotavirus vaccine in the past
3. Presence of any illness requiring hospital referral (temporary exclusion)
4. Known case of immunodeficiency disease, known HIV positive
5. Known case of chronic gastroenteritis disease
6. Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no
exclusion criteria but seems â??illâ??, investigators suspects neglect)
7. Diarrhea in the previous 24 hours
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method