Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule

PHASE3CompletedINTERVENTIONAL
Enrollment

351

Participants

Timeline

Start Date

January 1, 2006

Primary Completion Date

January 1, 2007

Study Completion Date

January 25, 2007

Conditions
Infections, Streptococcal
Interventions
BIOLOGICAL

GSK Biologicals' 10-valent pneumococcal conjugate vaccine.

Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule).

BIOLOGICAL

Infanrix hexa.

Intramuscular injection, 3 doses (2-4-11 months of age schedule).

BIOLOGICAL

Infanrix-IPV/Hib.

Intramuscular injection, 3 doses (2-4-11 months of age schedule).

Trial Locations (8)

2650

GSK Investigational Site, Hvidovre

5125

GSK Investigational Site, Morvik

0130

GSK Investigational Site, Oslo

026 01

GSK Investigational Site, Dolný Kubín

034 01

GSK Investigational Site, Ružomberok

SE-416 73

GSK Investigational Site, Gothenburg

SE-702 11

GSK Investigational Site, Örebro

SE-901 85

GSK Investigational Site, Umeå

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY