CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 450 enrolled
Drug / intervention
GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A) +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/NCT00911144
NCT00911144Phase 3Completed
CompareCT.gov

Booster Vaccination With Pneumococcal Vaccine GSK1024850A or Prevenar™ Co-administered With Hiberix™ in Children Primed With the Same Vaccines

GlaxoSmithKline·interventional·Posted Jun 1, 2009·Updated Sep 20, 2018

In Brief

A Phase 3 clinical trial evaluating GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A), Wyeth-Lederle's Prevenar™, and 1 other intervention for Infections, Streptococcal. Completed, enrolled 450 participants across 14 sites.

Detailed Summary

The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Streptococcal
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 1, 2009
Enrollment StartJun 11, 2009
Primary CompletionJan 11, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.1 years ago

Interventions

GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)biological

Intramuscular injection, administered as a single dose

Wyeth-Lederle's Prevenar™biological

Intramuscular injection, administered as a single dose

GSK Biologicals' Hiberix™biological

Intramuscular injection, administered as a single dose