CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 163 enrolled
Drug / intervention
Synflorix +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/NCT00513409
NCT00513409Phase 2Completed
CompareCT.gov

Phase II, Observer-blind Follow-up Study to Assess reacto-and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine (GSK1024850A), When Given as Booster in Primed Children or as 2-dose Catch-up in Unprimed Children.

GlaxoSmithKline·interventional·Posted Aug 8, 2007·Updated Dec 19, 2018

In Brief

A Phase 2 clinical trial evaluating Synflorix, Infanrix Hexa, and 1 other intervention for Infections, Streptococcal. Completed, enrolled 163 participants across 1 site.

Detailed Summary

This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination. This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2007
Enrollment StartAug 22, 2007
Primary CompletionFeb 20, 2008
Study CompletionAug 28, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.9 years ago

Interventions

Synflorixbiological

Intramuscular injection, 1 or 2 doses

Infanrix Hexabiological

1 Intramuscular injection

Havrixbiological

1 Intramuscular injection