To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination

CompletedOBSERVATIONAL
Enrollment

1,439

Participants

Timeline

Start Date

November 16, 2006

Primary Completion Date

March 31, 2010

Study Completion Date

July 17, 2010

Conditions
Infections, RotavirusRotavirus Vaccines
Interventions
BIOLOGICAL

Rotarix

Two doses of the oral vaccine

OTHER

Data collection

Safety evaluation: recording of adverse events by using diary cards and by non-leading questioning.

Trial Locations (18)

1000

GSK Investigational Site, Manila

1102

GSK Investigational Site, Quezon City

1113

GSK Investigational Site, Quezon City

1600

GSK Investigational Site, Pasig City, Metro Manila

1780

GSK Investigational Site, Alabang, Muntinlupa City

GSK Investigational Site, City of Muntinlupa

4027

GSK Investigational Site, Los Banos, Laguna

Unknown

GSK Investigational Site, Binangonan, Rizal

GSK Investigational Site, Cainta, Rizal

GSK Investigational Site, Gen. Trias, Cavite

GSK Investigational Site, Imus, Cavite

GSK Investigational Site, Makati City

GSK Investigational Site, Manila

GSK Investigational Site, Maybunga, Pasig City

GSK Investigational Site, Pasay

GSK Investigational Site, Quezon City

GSK Investigational Site, Talaba IV, Bacoor, Cavite

GSK Investigational Site, Taytay, Rizal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00353366 - To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination | Biotech Hunter | Biotech Hunter