Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.

PHASE3CompletedINTERVENTIONAL
Enrollment

1,613

Participants

Timeline

Start Date

February 12, 2007

Primary Completion Date

August 8, 2007

Study Completion Date

August 8, 2007

Conditions
Infections, Rotavirus
Interventions
BIOLOGICAL

Rotarix (primary vaccination study)

GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.

BIOLOGICAL

Placebo (primary vaccination study)

Two liquid oral doses of placebo

Trial Locations (15)

15140

GSK Investigational Site, Lahti

20520

GSK Investigational Site, Turku

28120

GSK Investigational Site, Pori

33100

GSK Investigational Site, Tampere

33520

GSK Investigational Site, Tampere

48600

GSK Investigational Site, Kotka

60100

GSK Investigational Site, Seinäjoki

70100

GSK Investigational Site, Kuopio

90100

GSK Investigational Site, Oulu

02100

GSK Investigational Site, Espoo

00100

GSK Investigational Site, Helsinki

00930

GSK Investigational Site, Helsinki

04400

GSK Investigational Site, Järvenpää

01300

GSK Investigational Site, Vantaa

01600

GSK Investigational Site, Vantaa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY