Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine

PHASE3CompletedINTERVENTIONAL
Enrollment

854

Participants

Timeline

Start Date

August 31, 2003

Primary Completion Date

January 31, 2004

Study Completion Date

January 31, 2004

Conditions
Infections, Rotavirus
Interventions
BIOLOGICAL

Rotarix

Two oral doses.

BIOLOGICAL

Placebo

Two oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles.

Trial Locations (4)

14050

GSK Investigational Site, Mexico City

Unknown

GSK Investigational Site, Cali Colombia

GSK Investigational Site

Lima

GSK Investigational Site, Lima

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY