A phase III randomized, single-blind, controlled study to demonstrate the non-inferiority of co-administration of GSK Biologicals' 10-valent pneumococcal conjugate vaccine with Pediacel™ versus co-administration with Infanrix hexa™, when administered to infants as a three-dose primary vaccination course during the first six months of life and as a booster dose at 11-13 months of age.
Phase of Trial: Phase III
Latest Information Update: 17 Oct 2016
At a glance
- Drugs Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa) (Primary) ; Pneumococcal 10-valent vaccine conjugate (Primary) ; Hib-DTaP-poliovirus vaccine; Pneumococcal 7-valent CRM197 vaccine conjugate
- Indications Diphtheria; Haemophilus infections; Hepatitis B; Otitis media; Pertussis; Pneumococcal infections; Poliomyelitis; Tetanus
- Focus Pharmacodynamics; Registrational
- Sponsors GlaxoSmithKline
- 28 Oct 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
- 17 Dec 2010 Planned End Date changed from 1 Nov 2010 to 1 Dec 2010 as reported by ClinicalTrials.gov.
- 13 Jan 2010 Planned end date changed from 1 May 2010 to 1 Nov 2010 as reported by ClinicalTrials.gov.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History