CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 282 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/NCT01030822
NCT01030822Phase 3Completed

Booster Vaccination With Pneumococcal Vaccine GSK1024850A in Primed Children and Catch-up Vaccination in Unprimed Children

GlaxoSmithKline·interventional·Posted Dec 14, 2009·Updated Sep 20, 2018

In Brief

A Phase 3 clinical trial evaluating Pneumococcal vaccine GSK1024850A for Infections, Streptococcal. Completed, enrolled 282 participants across 4 sites.

Detailed Summary

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of pneumococcal vaccine GSK1024850A administered either at 9-18 months or 15-18 months of age in children primed in primary study NCT00814710. This study also aims to assess the persistence of antibodies induced following primary vaccination with pneumococcal vaccine GSK1024850A in primary study NCT00814710 prior to booster vaccination and following vaccination in the present study at approximately 24 months of age. The study is also designed to evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A when administered as a catch-up vaccination (2+1) in the second year of life in children unprimed with vaccine GSK1024850A in study NCT00814710.

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 14, 2009
Enrollment StartApr 2, 2010
Primary CompletionAug 19, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.6 years ago

Interventions

Pneumococcal vaccine GSK1024850Abiological

Intramuscular injection, administered as a single dose

Pneumococcal vaccine GSK1024850Abiological

Intramuscular injection, 3 doses