CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 466 enrolled
Drug / intervention
Pneumococcal vaccine GSK1024850Abiological
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/NCT00950833
NCT00950833Phase 3Completed

Vaccination Course in Children Primed and Boosted With Pneumococcal Vaccine GSK 1024850A and in Age-matched Unprimed Children

GlaxoSmithKline·interventional·Posted Aug 3, 2009·Updated Sep 20, 2018

In Brief

A Phase 3 clinical trial evaluating Pneumococcal vaccine GSK1024850A for Infections, Streptococcal. Completed, enrolled 466 participants across 10 sites.

Detailed Summary

The objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H. influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A in previous primary and booster studies. For subjects that did not receive the investigational vaccine during the primary and booster study, the objective is to evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A. This protocol posting deals with objectives \& outcome measures of the extension phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00370318). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT00496015).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 3, 2009
Enrollment StartAug 10, 2009
Primary CompletionSep 16, 2010
Study CompletionOct 27, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.9 years ago

Interventions

Pneumococcal vaccine GSK1024850Abiological

1 or 2 intramuscular injections