NCT00586612View on ClinicalTrials.gov

Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

313

Participants

Timeline

Start Date

December 1, 2007

Primary Completion Date

December 30, 2008

Study Completion Date

December 30, 2008

Conditions
Haemophilus Influenzae Type bNeisseria Meningitidis
Interventions
BIOLOGICAL

Menitorix™

Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.

BIOLOGICAL

Infanrix™ penta

Intramuscular injection, 3 doses in the primary study

BIOLOGICAL

Prevenar™

Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.

BIOLOGICAL

Infanrix™ IPV

Intramuscular injection, 1 dose in the Booster study.

Trial Locations (8)

28041

GSK Investigational Site, Madrid

28047

GSK Investigational Site, Madrid

28905

GSK Investigational Site, Getafe

28935

GSK Investigational Site, Móstoles/Madrid

29010

GSK Investigational Site, Málaga

48013

GSK Investigational Site, Bilbao

08035

GSK Investigational Site, Barcelona

09005

GSK Investigational Site, Burgos

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00586612 - Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants | Biotech Hunter | Biotech Hunter