CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 41,188 enrolled
Drug / intervention
Pneumococcal conjugate vaccine GSK1024850A +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/NCT00861380
NCT00861380Phase 3Completed
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Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease

GlaxoSmithKline·interventional·Posted Mar 13, 2009·Updated Dec 17, 2020

In Brief

A Phase 3 clinical trial evaluating Pneumococcal conjugate vaccine GSK1024850A, GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine), and 1 other intervention for Infections, Streptococcal and Streptococcus Pneumoniae. Completed, enrolled 41,188 participants across 1 site.

Detailed Summary

The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), administered according to different vaccination schedules, against invasive disease caused by S. pneumoniae or H. influenzae as well as vaccine impact on the occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions. This study will also explore vaccine impact on occurrence of respiratory tract infections (RTIs), including acute otitis media (AOM) in a subset of children in Turku area.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Streptococcal, Streptococcus Pneumoniae
CountriesFinland
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 13, 2009
Enrollment StartMay 4, 2009
Primary CompletionJan 31, 2012
Study CompletionOct 5, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.3 years ago

Interventions

Pneumococcal conjugate vaccine GSK1024850Abiological

2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination

GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)biological

3 or 4 Intramuscular injections, depending on the age at the time of first vaccination. Control 3+1 and Control 2+1 groups, only for children \< 12 months of age at the time of first study vaccination.

GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)biological

2 Intramuscular injections. Control 3+1 and Control 2+1 groups, only for children \>= 12 months of age at the time of first study vaccination.