CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 23,802 enrolled
Drug / intervention
Pneumococcal conjugate vaccine GSK1024850A +4 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/NCT00466947
NCT00466947Phase 3Completed
CompareCT.gov

COMPAS: A Phase III Study to Demonstrate Efficacy of GSK Biologicals' 10-valent Pneumococcal Vaccine (GSK1024850A) Against Community Acquired Pneumonia and Acute Otitis Media

GlaxoSmithKline·interventional·Posted Apr 27, 2007·Updated Jul 16, 2019

In Brief

A Phase 3 clinical trial evaluating Pneumococcal conjugate vaccine GSK1024850A, Havrix, and 3 other interventions for Infections, Streptococcal. Completed, enrolled 23,802 participants across 22 sites in 3 countries.

Detailed Summary

This is a study in a large number of healthy children less than 3 years old to measure the efficacy of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate candidate vaccine (Synflorix vaccine, or GSK1024850A) to prevent cases of pneumonia (lung infection) likely caused by bacteria (Streptococcus pneumoniae and Haemophilus influenzae) or cases of otitis media (ear infection) in children under 3 years old.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Streptococcal
CountriesArgentina, Colombia, Panama
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 27, 2007
Enrollment StartJun 28, 2007
Primary CompletionAug 31, 2010
Study CompletionJul 28, 2011
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 19.2 years ago

Interventions

Pneumococcal conjugate vaccine GSK1024850Abiological

Intramuscular injection, 4 doses

Havrixbiological

Intramuscular injection, 2 doses in Synflorix group and 3 doses in Control group

Engerix-Bbiological

Intramuscular injection, 3 doses

Infanrix hexabiological

Intramuscular injection,3 doses

GSK Biologicals' DTPa-IPV/Hib vaccinebiological

Intramuscular injection, 1 dose in Synflorix group and 4 doses in Control group