NCT00586612

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

Immunogenicity & Safety Study in Preterm & Full-term Infants of GSK Biologicals' Hib-MenC Vaccine, Menitorix™ Co-administered With Infanrix™ Penta & Prevenar™ at 2, 4, 6 Months & as a Booster With Infanrix™ IPV & Prevenar™ at 16-18 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 8 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this Phase IIIb study is to evaluate the immunogenicity, reactogenicity \& safety of GSK Biologicals' Hib-MenC vaccine (Menitorix™) when co-administered with GSK Biologicals' DTPa-HBV-IPV vaccine (Infanrix™ penta) \& Wyeth's 7-valent pneumococcal conjugate vaccine (Prevenar™) in preterm infants as a 3-dose primary vaccination course during the first 6 months of life (at 2, 4, 6 months of age) and of a booster dose of Menitorix™ when co-administered with GSK Biologicals' DTPa-IPV vaccine (Infanrix IPV) and Wyeth's Prevenar in the second year of life (16-18 months of age). The control is a group of full-term infants receiving the same vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

This multicenter study is open \& consists of a primary \& a booster phase. The study has 2 treatment groups (Preterm \& Full-term) that will receive the same vaccinations; the Full-term group will be the active control. Four blood samples will be collected from all subjects for immunogenicity analyses; 2 in the primary phase at prior to the first vaccination and one month after the third vaccination and 2 in the booster phase at prior to booster dose and one month after booster dose.

Conditions

• Haemophilus Influenzae Type b
• Neisseria Meningitidis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-12-30
• Completion: 2008-12-30
• First posted: 2008-01-04
• Last updated: 2018-08-27
• Results posted: 2010-01-22

Locations

8 sites across 1 country: Spain