Enhancing Gut Mucosal Immune Response to oral poliovirus vaccine using inactivated poliovirus vaccines
Not Applicable
Completed
- Registration Number
- CTRI/2012/09/003005
- Lead Sponsor
- Christian Medical College Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 450
Inclusion Criteria
Children who have received trivalent OPV vaccines in primary series and the last dose of any oral poliovirus vaccine 6 months or more
remote in the past.
Exclusion Criteria
Child has a known digestive system defect.
Child has history of chronic diarrhea (lasting more than 14 days).
Child has major congenital anomalies.
Child has known immunodeficiency
Child has received a prior dose of IPV
Child has received a dose of OPV in the last 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method proportion of children shedding type 1 polio virus.Timepoint: 7 days after bOPV challenge
- Secondary Outcome Measures
Name Time Method geometric mean titre of poliovirus-specific IgA in <br/ ><br>saliva samplesTimepoint: 28 days after intervention;proportion of children shedding type 1 vaccine virus.Timepoint: 14 and 21 days after bOPV challenge;serum neutralizing antibody titre against poliovirusTimepoint: 28 days after intervention;viral copies per gram of stool estimated by RTPCRTimepoint: baseline, day 7, day 14, day 21 and day 28 post bOPV challenge