A Study to Evaluate Safety and Immunogenicity of tOPV in 1 to 5 Years and at 6 Weeks of Age

PHASE4CompletedINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

July 31, 2016

Study Completion Date

August 11, 2016

Conditions
Poliomyelitis
Interventions
BIOLOGICAL

Oral Polio Vaccine

"Opvero™ (oral) is a trivalent, live attenuated poliomyelitis virus vaccine containing at least 6.0 log 50% cell culture infective dose (CCID50) of LS c2ab strain of live attenuated polio virus type 1, 5.0 log CCID50 of P712, Ch, 2ab strain of live attenuated polio virus type 2, 5.8 log CCID50 Leon I2aIb strain of polio virus type 3. Excipients: human albumin, HEPES buffer solution, magnesium chloride solution (containing polysorbate 80 and phenol red), hydrochloric acid or sodium hydroxide for pH adjustment.~The vaccine is presented as a suspension for oral administration. One dose of vaccine (0.1 ml) is contained in two drops which are delivered from the dropper supplied with the multidose container."

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

lead

Fidec Corporation

OTHER