CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 230 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/NCT00533507
NCT00533507Phase 3Completed
CompareCT.gov

Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Infanrix Hexa and Rotarix

GlaxoSmithKline·interventional·Posted Sep 21, 2007·Updated Jun 8, 2018

In Brief

A Phase 3 clinical trial evaluating Synflorix, Infanrix hexa, and 1 other intervention for Infections, Rotavirus. Completed, enrolled 230 participants across 3 sites.

Detailed Summary

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Taiwanese infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine and rotavirus vaccine in children during the first 6 months of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Rotavirus
CountriesTaiwan
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2007
Enrollment StartSep 18, 2007
Primary CompletionJun 1, 2008
Study CompletionJun 6, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.8 years ago

Interventions

Synflorixbiological

Intramuscular injection, 3 doses.

Infanrix hexabiological

Intramuscular injection, 3 doses.

Rotarixbiological

Oral, 2 doses.