Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC

PHASE3CompletedINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

July 31, 2006

Study Completion Date

September 30, 2010

Conditions
Haemophilus Influenzae Type bNeisseria Meningitidis
Interventions
BIOLOGICAL

Haemophilus influenzae type b- and meningococcal (vaccine)

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

BIOLOGICAL

Infanrix™ penta

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

BIOLOGICAL

Infanrix™ hexa

Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

BIOLOGICAL

Engerix-B

Intramuscular injection into the thigh as a birth dose

BIOLOGICAL

NeisVac-C™

Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.

BIOLOGICAL

Infanrix™ IPV/HIB

Intramuscular injection into the thigh as primary vaccination at 4 months of age

BIOLOGICAL

Meningitec™

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

Trial Locations (12)

17002

GSK Investigational Site, Girona

28007

GSK Investigational Site, Madrid

28040

GSK Investigational Site, Marid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28905

GSK Investigational Site, Getafe/Madrid

28935

GSK Investigational Site, Móstoles/Madrid

29011

GSK Investigational Site, Málaga

29700

GSK Investigational Site, Vélez-Málaga / Málaga

47010

GSK Investigational Site, Valladolid

04009

GSK Investigational Site, Almería

09005

GSK Investigational Site, Burgos

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00322335 - Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC | Biotech Hunter | Biotech Hunter