CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 218 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/NCT00985465
NCT00985465Phase 3Completed
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Safety, Reactogenicity and Immunogenicity Study of GSK Biologicals' Pneumococcal Vaccine GSK1024850A, Given Either as a Booster Dose or as a 2-dose Catch-up Immunization in Healthy Malian Children

GlaxoSmithKline·interventional·Posted Sep 28, 2009·Updated Dec 14, 2018

In Brief

A Phase 3 clinical trial evaluating Pneumococcal vaccine GSK1024850A for Infections, Streptococcal. Completed, enrolled 218 participants across 1 site.

Detailed Summary

The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects previously enrolled in the primary vaccination study NCT00678301. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00678301).

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2009
Enrollment StartNov 12, 2009
Primary CompletionJun 26, 2010
Study CompletionJul 26, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.8 years ago

Interventions

Pneumococcal vaccine GSK1024850Abiological

Intramuscular injection, 1 or 2 doses