3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age

PHASE2CompletedINTERVENTIONAL
Enrollment

388

Participants

Timeline

Start Date

March 1, 2003

Primary Completion Date

December 1, 2003

Study Completion Date

December 16, 2003

Conditions
Haemophilus Influenzae Type bNeisseria Meningitidis
Interventions
BIOLOGICAL

Hib-MenCY-TT vaccine

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

BIOLOGICAL

Hib-MenC-TT vaccine

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

BIOLOGICAL

Menjugate ®

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

BIOLOGICAL

Infanrix penta ®

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

BIOLOGICAL

Infanrix hexa ®

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

Trial Locations (26)

1730

GSK Investigational Site, Asse

9000

GSK Investigational Site, Ghent

9031

GSK Investigational Site, Drongen

9040

GSK Investigational Site, Sint-Amandsberg

9700

GSK Investigational Site, Oudenaarde

9820

GSK Investigational Site, Merelbeke

9990

GSK Investigational Site, Maldegem

10315

GSK Investigational Site, Berlin

12627

GSK Investigational Site, Berlin

13355

GSK Investigational Site, Berlin

14197

GSK Investigational Site, Berlin

22307

GSK Investigational Site, Hamburg

24937

GSK Investigational Site, Flensburg

24943

GSK Investigational Site, Flensburg

25821

GSK Investigational Site, Bredstedt

32278

GSK Investigational Site, Kirchlengern

32584

GSK Investigational Site, Löhne

32756

GSK Investigational Site, Detmold

65527

GSK Investigational Site, Niedernhausen

80939

GSK Investigational Site, Munich

81675

GSK Investigational Site, Munich

82140

GSK Investigational Site, Olching

86720

GSK Investigational Site, Nördlingen

86916

GSK Investigational Site, Kaufering

93413

GSK Investigational Site, Cham

04178

GSK Investigational Site, Leipzig

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY