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Enhancing Gut Mucosal Immune Response to oral poliovirus vaccine using inactivated poliovirus vaccines

Effect of Inactivated Poliovirus Vaccine on Gut Immunity against Poliovirus in children who have received Oral Polio Vaccine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/09/003005
Enrollment
450
Registered
2012-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Inactivated Poliovirus Vaccine: IPV given intramuscularly (0.5 ml) in children who are previously immunized with trivalent OPV six or more months in the past Control Intervention1: Biva

Sponsors

Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
proportion of children shedding type 1 polio virus.Timepoint: 7 days after bOPV challenge

Secondary

MeasureTime frame
geometric mean titre of poliovirus-specific IgA in 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

Countries

India

Contacts

Public ContactJacob John

Christian Medical College

jacob@cmcsph.org04162284207

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 20, 2026