Immune response and safety of a mixed regimen of rotavirus vaccines (Rotavac and Rotasiil)
- Registration Number
- CTRI/2018/08/015317
- Lead Sponsor
- Ministry of Health and Family Welfare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy infants, as established by medical history and clinical examination before entering the study.
2.Age: 6-8 weeks at the time of enrollment.
3.Parental ability and willingness to provide informed consent.
4.Parent who intends to remain in the area with the child during the study period.
1.Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
2.Presence of fever on the day of enrollment (temporary exclusion).
3.Acute disease at the time of enrollment (temporary exclusion).
4.Concurrent participation in another clinical trial throughout the entire timeframe for this study.
5.Presence of significant malnutrition (weight-for-height z-score <-3SD median) or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the subjectâ??s health or is likely to result in nonconformance to the protocol.
6.History of congenital abdominal disorders, intussusception or abdominal surgery
7.Known or suspected impairment of immunological function based on medical history and physical examination.
8.Prior receipt of rotavirus vaccine.
9.History of persistent diarrhea (defined as diarrhea more than 14 days).
10.Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
11.History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
12.Any medical condition in the parents/infant which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participantâ??s parents ability to give informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method