Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants

CompletedOBSERVATIONAL
Enrollment

332

Participants

Timeline

Start Date

August 3, 2009

Primary Completion Date

February 20, 2010

Study Completion Date

April 23, 2010

Conditions
Infections, Rotavirus
Interventions
BIOLOGICAL

Rotarix™

Two doses of oral vaccine.

Trial Locations (12)

110085

GSK Investigational Site, Delhi

110087

GSK Investigational Site, New Delhi

110088

GSK Investigational Site, Delhi

400081

GSK Investigational Site, Mumbai

411044

GSK Investigational Site, Pune

700064

GSK Investigational Site, Kolkata

560 011

GSK Investigational Site, Bangalore

560 095

GSK Investigational Site, Bangalore

600 033

GSK Investigational Site, Chennai

Unknown

GSK Investigational Site, Kolkata

GSK Investigational Site, Mumbai

400 053

GSK Investigational Site, Mumbai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00938327 - Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants | Biotech Hunter | Biotech Hunter