NCT02141204View on ClinicalTrials.gov

Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

451

Participants

Timeline

Start Date

February 20, 2019

Primary Completion Date

December 28, 2019

Study Completion Date

December 28, 2019

Conditions
Rotavirus
Interventions
BIOLOGICAL

HRV Liquid

Two doses administered orally according to a 0, 1-month schedule.

BIOLOGICAL

HRV Lyophilized

Two doses administered orally according to a 0, 1-month schedule.

Trial Locations (8)

400012

GSK Investigational Site, Mumbai

560002

GSK Investigational Site, Bangalore

632002

GSK Investigational Site, Vellore

632004

GSK Investigational Site, Vellore

700017

GSK Investigational Site, Kolkata

141 008

GSK Investigational Site, Ludhiana

411 011

GSK Investigational Site, Pune

Unknown

GSK Investigational Site, Pune

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02141204 - Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants | Biotech Hunter | Biotech Hunter