To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

1,009

Participants

Timeline

Start Date

January 25, 2007

Primary Completion Date

March 1, 2008

Study Completion Date

March 25, 2008

Conditions
Infections, Rotavirus
Interventions
BIOLOGICAL

Rotarix™

Two-dose oral vaccination.

BIOLOGICAL

Placebo

Two-dose oral administration

Trial Locations (31)

13915

GSK Investigational Site, Marseille

14033

GSK Investigational Site, Caen

28041

GSK Investigational Site, Madrid

28047

GSK Investigational Site, Madrid

28935

GSK Investigational Site, Móstoles/Madrid

28942

GSK Investigational Site, Fuenlabrada (Madrid)

29010

GSK Investigational Site, Málaga

33076

GSK Investigational Site, Bordeaux

47010

GSK Investigational Site, Valladolid

48013

GSK Investigational Site, Bilbao

50345

GSK Investigational Site, Wroclaw

59037

GSK Investigational Site, Lille

63058

GSK Investigational Site, Clermont-Ferrand

69437

GSK Investigational Site, Lyon

75014

GSK Investigational Site, Paris

93140

GSK Investigational Site, Bondy

85-021

GSK Investigational Site, Bydgoszcz

39-200

GSK Investigational Site, Dębica

31-503

GSK Investigational Site, Krakow

91-347

GSK Investigational Site, Lodz

39-300

GSK Investigational Site, Mielec

61-709

GSK Investigational Site, Poznan

41-103

GSK Investigational Site, Siemianowice Śląskie

2720-276 Amadora

GSK Investigational Site, Amadora

1069-089

GSK Investigational Site, Lisbon

1169-045 Lisboa

GSK Investigational Site, Lisbon

1449-005 Lisboa

GSK Investigational Site, Lisbon

4050-371 PORTO

GSK Investigational Site, Porto

04009

GSK Investigational Site, Almería

08036

GSK Investigational Site, Barcelona

09005

GSK Investigational Site, Burgos

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY