CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 105 enrolled
Drug / intervention
Pneumococcal vaccine GSK1024850A +1 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/NCT01153893
NCT01153893Phase 3Completed
CompareCT.gov

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 Nigerian Children

GlaxoSmithKline·interventional·Posted Jun 30, 2010·Updated Sep 20, 2018

In Brief

A Phase 3 clinical trial evaluating Pneumococcal vaccine GSK1024850A and InfanrixTM for Infections, Streptococcal. Completed, enrolled 105 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 Nigerian 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
CountriesNigeria
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 30, 2010
Enrollment StartOct 4, 2010
Primary CompletionFeb 16, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.0 years ago

Interventions

Pneumococcal vaccine GSK1024850Abiological

Intramuscular injection, 1 or 2 doses

InfanrixTMbiological

Intramuscular injection, 1dose