CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 503 enrolled
Drug / intervention
Pneumococcal vaccine GSK1024850A (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/NCT00680914
NCT00680914Phase 3Completed

Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A or Prevenar™ Co-administered With Hiberix™

GlaxoSmithKline·interventional·Posted May 20, 2008·Updated Jun 8, 2018

In Brief

A Phase 3 clinical trial evaluating Pneumococcal vaccine GSK1024850A (Synflorix), Prevenar, and 1 other intervention for Infections, Streptococcal. Completed, enrolled 503 participants across 14 sites.

Detailed Summary

The purposes of this study are: To demonstrate the immunogenicity in terms of antibody response following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™ when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during the first 6 months of life. To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 20, 2008
Enrollment StartJun 10, 2008
Primary CompletionMay 8, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.1 years ago

Interventions

Pneumococcal vaccine GSK1024850A (Synflorix)biological

3 doses administered intramuscularly.

Prevenarbiological

3 doses administered intramuscularly.

GSK Biologicals' Hiberix™biological

3 doses administered intramuscularly.