CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 365 enrolled
Drug / intervention
GSK Biologicals' Synflorix™ +2 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/NCT00678301
NCT00678301Phase 3Completed

Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Zilbrix™ Hib and Polio Sabin™

GlaxoSmithKline·interventional·Posted May 15, 2008·Updated Nov 15, 2019

In Brief

A Phase 3 clinical trial evaluating GSK Biologicals' Synflorix™, GSK Biologicals' Polio Sabin™, and 1 other intervention for Infections, Streptococcal. Completed, enrolled 365 participants across 2 sites in 2 countries.

Detailed Summary

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMali, Nigeria
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 15, 2008
Enrollment StartJun 18, 2008
Primary CompletionNov 9, 2009
Study CompletionDec 10, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.1 years ago

Interventions

GSK Biologicals' Synflorix™biological

3 IM doses.

GSK Biologicals' Polio Sabin™biological

3 oral doses

GSK Biologicals' Zilbrix™ Hibbiological

3 IM doses.