NCT00871338

Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants

Study in Healthy Children of GSK Biologicals' DTPa-IPV/Hib-MenC-TT Vaccine, GSK2197870A, Co-administered With Prevenar™ as a Three-dose Primary Vaccination Course in Infancy Followed by a Booster Dose of Menitorix™ at 12 Months of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.

Detailed description

This protocol posting has been updated following Protocol amendment 1, 11-February-2010; The Study design section is impacted by this amendment.

Conditions

• Neisseria Meningitidis
• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	GSK2197870A	3 doses given at 2, 3 and 4 months of age
BIOLOGICAL	Prevenar™	3 co-administered doses, intramuscular into right thigh
BIOLOGICAL	Menitorix™	1 booster dose at 12 months of age
BIOLOGICAL	Pediacel™	3 doses given at 2, 3 and 4 months of age
BIOLOGICAL	Menjugate™	2 doses given at 3 and 4 months of age

Timeline

• Start date: 2009-06-24
• Primary completion: 2010-03-31
• Completion: 2010-12-09
• First posted: 2009-03-30
• Last updated: 2018-06-06
• Results posted: 2014-07-28

Locations

5 sites across 1 country: United Kingdom