NCT02766816 - A Clinical Study Comparing Safety and Immunogenicity of bOPV of Bilthoven Biologicals | Biotech Hunter

Enrollment

1,120

Participants

Timeline

Start Date

June 8, 2016

Primary Completion Date

February 14, 2018

Study Completion Date

February 14, 2018

Conditions

Immune Response to Oral Polio Vaccine

Interventions

BIOLOGICAL

Part 1 study - BBio bOPV

A single dose of 2 drops (0.1 ml) orally of BBio bOPV to 20 children 60 to 83 months of age.

BIOLOGICAL

Part 2 study - BBio bOPV Lot 1

Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 1 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.

BIOLOGICAL

Part 2 study - BBio bOPV Lot 2

Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 2 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.

BIOLOGICAL

Part 2 study - BBio bOPV Lot 3

Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 3 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.

BIOLOGICAL

Part 2 study - Licensed bOPV

Three doses of 2 drops (0.1 ml) orally of a licensed bOPV to 270 infants at 6-8, 10-12 and 14-16 weeks of age.

BIOLOGICAL

Part 1 study - Licensed bOPV

A single dose of 2 drops (0.1 ml) orally of a licensed bOPV to 20 children 60 to 83 months of age.

Trial Locations (1)

Matlab Hospital Research Centre, International Center for Diarrheal Disease Research, Matlab, Matlab South, Chandpur District