Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

765

Participants

Timeline

Start Date

June 19, 2007

Primary Completion Date

March 31, 2009

Study Completion Date

November 21, 2009

Conditions
Infections, RotavirusRotavirus Vaccines
Interventions
BIOLOGICAL

Rotarix

Two-dose oral vaccination.

BIOLOGICAL

Placebo

Two-dose oral administration.

Trial Locations (20)

451-0052

GSK Investigational Site, Aichi

275-8580

GSK Investigational Site, Chiba

802-8533

GSK Investigational Site, Fukuoka

720-8520

GSK Investigational Site, Hiroshima

730-8518

GSK Investigational Site, Hiroshima

730-8798

GSK Investigational Site, Hiroshima

734-8530

GSK Investigational Site, Hiroshima

737-0811

GSK Investigational Site, Hiroshima

003-0021

GSK Investigational Site, Hokkaido

065-0033

GSK Investigational Site, Hokkaido

765-8501

GSK Investigational Site, Kagawa

247-8533

GSK Investigational Site, Kanagawa

981-3203

GSK Investigational Site, Miyagi

983-8520

GSK Investigational Site, Miyagi

386-8610

GSK Investigational Site, Nagano

856-8562

GSK Investigational Site, Nagasaki

957-8588

GSK Investigational Site, Niigata

701-0204

GSK Investigational Site, Okayama

701-1192

GSK Investigational Site, Okayama

591-8025

GSK Investigational Site, Osaka

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY