CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 780 enrolled
Drug / intervention
GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™) +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00652951
NCT00652951Phase 3Completed
CompareCT.gov

Non-inferiority of Co-administration of GSK Biologicals'Pneumococcal Conjugate Vaccine GSK1024850A With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib.

GlaxoSmithKline·interventional·Posted Apr 4, 2008·Updated Jun 26, 2019

In Brief

A Phase 3 clinical trial evaluating GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™), Infanrix™ hexa., and 2 other interventions for Infections, Streptococcal. Completed, enrolled 780 participants across 1 site.

Detailed Summary

The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a three-dose primary immunisation course during the first 6 months of life and as a booster dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two years of life will also be assessed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Streptococcal
CountriesNetherlands
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 4, 2008
Enrollment StartApr 1, 2008
Primary CompletionMay 12, 2009
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.2 years ago

Interventions

GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)biological

Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination

Infanrix™ hexa.biological

Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination

Pediacel™biological

Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination

Prevenar™biological

Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination