CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,437 enrolled
Drug / intervention
Pneumococcal conjugate vaccine GSK1024850A +8 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/NCT00463437
NCT00463437Phase 3Completed
CompareCT.gov

Booster Vaccination With Pneumococcal Vaccine GSK1024850A, a DTPa-Combined and MenC or Hib-MenC Vaccines

GlaxoSmithKline·interventional·Posted Apr 20, 2007·Updated Jan 2, 2020

In Brief

A Phase 3 clinical trial evaluating Pneumococcal conjugate vaccine GSK1024850A, Prevenar, and 7 other interventions for Hepatitis B and 5 related conditions. Completed, enrolled 1,437 participants across 63 sites in 3 countries.

Detailed Summary

The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus influenzae type b (Hib-MenC) vaccine. 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 = NCT00334334).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Acellular Pertussis, Tetanus, Poliomyelitis, Diphtheria, Streptococcus Pneumoniae Vaccines
CountriesGermany, Poland, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 20, 2007
Enrollment StartApr 25, 2007
Primary CompletionJan 21, 2008
Study CompletionJun 14, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 19.2 years ago

Interventions

Pneumococcal conjugate vaccine GSK1024850Abiological

Intramuscular injection, 1 dose.

Prevenarbiological

Intramuscular injection, 1 dose.

Infanrix hexabiological

Intramuscular injection, 1 dose. In Germany and Poland.

Infanrix IPV Hibbiological

Intramuscular injection, 1 dose. In Spain.

Infanrix pentabiological

Intramuscular injection, 1 dose. In Germany and Poland.

Infanrix IPVbiological

Intramuscular injection, 1 dose. In Spain.

Meningitecbiological

Intramuscular injection, 1 dose.

NeisVac-Cbiological

Intramuscular injection, 1 dose.

Menitorixbiological

Intramuscular injection, 1 dose.