Zinc and probiotics to enhance immunogenicity of oral vaccines
- Registration Number
- CTRI/2012/05/002677
- Lead Sponsor
- Department of Biotechnology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 560
•Infants 35-41 days old.
•Live in area under surveillance.
•Current weight >=3.2 kg.
•No syndromic evidence of immunocompromise.
•No prior illness requiring hospitalization.
•No current medical condition as determined by medical doctor which precludes study involvement.
•Available for follow up for duration of study (through approximately 14 weeks of age).
•Parents/guardians of infant are able to understand and follow study procedures and agree to participate in the study by providing signed informed consent.
•Child has history of atopic symptoms.
•Child has a known digestive system defect.
•Child has history of chronic diarrhea.
•Child has major congenital anomalies.
•Child has received a prior dose of rotavirus vaccine.
•Child has received a prior dose of polio vaccine (beyond the birth dose).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢To evaluate the serologic immune response to rotavirus vaccine among Indian infants receiving zinc supplementation or a probiotic given daily for a week prior to the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a zinc or probiotic placebo <br/ ><br>Timepoint: 4 weeks after the second dose of immunization <br/ ><br>
- Secondary Outcome Measures
Name Time Method â?¢To evaluate the serologic immune response to oral polio vaccine among Indian infants receiving zinc or probiotic supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral polio vaccine compared to those receiving a zinc or probiotic placeboTimepoint: 4 weeks after the second dose of immunization