Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

308

Participants

Timeline

Start Date

September 12, 2005

Primary Completion Date

November 1, 2006

Study Completion Date

November 23, 2006

Conditions
Hepatitis B
Interventions
BIOLOGICAL

Tritanrix™-HepB

GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.

BIOLOGICAL

Rotarix™

GSK Biologicals' live attenuated human rotavirus vaccine

BIOLOGICAL

Zilbrix™

GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine

BIOLOGICAL

Triple Antigen™

Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.

BIOLOGICAL

Engerix™-B

GSK Biologicals' hepatitis B vaccine

DRUG

Placebo

Placebo for the Rotarix™ vaccine

Trial Locations (9)

119991

GSK Investigational Site, Moscow

129347

GSK Investigational Site, Moscow

141280

GSK Investigational Site, Ivanteevka Moscow Region

197022

GSK Investigational Site, Saint Petersburg

443021

GSK Investigational Site, Samara

620003

GSK Investigational Site, Yekaterinburg

656049

GSK Investigational Site, Barnaul

660027

GSK Investigational Site, Krasnoyarsk

634 050

GSK Investigational Site, Tomsk

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY