A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine

PHASE2CompletedINTERVENTIONAL
Enrollment

1,025

Participants

Timeline

Start Date

December 4, 2018

Primary Completion Date

February 19, 2020

Study Completion Date

February 19, 2020

Conditions
Poliomyelitis
Interventions
BIOLOGICAL

nOPV2 (monovalent oral polio vaccine)

"Cohort A: 150 IPV and/or OPV vaccinated participants aged 1 to 5 years vaccinated with candidate 1 or 2; two 10‸6 CCID50 (50% cell culture infective dose) doses separated by 28 days.~Cohort B: 972 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 10‸5 CCID50 dose of candidate 1 or 2."

Trial Locations (2)

Unknown

Cevaxin Vaccination Center, David

Cevaxin Vaccination Center, Panama City

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

lead

Fidec Corporation

OTHER

NCT03554798 - A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine | Biotech Hunter | Biotech Hunter