Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine

PHASE2CompletedINTERVENTIONAL
Enrollment

409

Participants

Timeline

Start Date

March 1, 2003

Primary Completion Date

February 1, 2004

Study Completion Date

February 12, 2004

Conditions
Haemophilus Influenzae Type bNeisseria Meningitidis
Interventions
BIOLOGICAL

Hib-MenCY-TT vaccine (MenHibrix)

Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively

BIOLOGICAL

Meningitec®

Three doses were administered IM in right lower thigh at Months 0,2 and 4.

BIOLOGICAL

ActHIB®

Three doses were administered IM in left thigh at Months 0,2 and 4.

BIOLOGICAL

Infanrix® Penta

Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.

BIOLOGICAL

Prevenar®

Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.

BIOLOGICAL

Mencevax® ACWY

One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.

BIOLOGICAL

PRP (Polyribosyl Ribitol Phosphate)

One dose was administered IM in deltoid region of left arm at Month 10 as booster.

Trial Locations (3)

3053

GSK Investigational Site, Carlton

5006

GSK Investigational Site, North Adelaide

6018

GSK Investigational Site, Subiaco

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY