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/NCT00489554
NCT00489554Phase 3Completed
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Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Infanrix Hexa and Rotarix

GlaxoSmithKline·interventional·Posted Jun 21, 2007·Updated Jan 13, 2020

In Brief

A Phase 3 clinical trial evaluating Synflorix, Infanrix hexa, and 1 other intervention for Infections, Streptococcal and Streptococcus Pneumoniae Vaccines. Completed, enrolled 230 participants across 2 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 Mexican infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine (Infanrix hexa) and rotavirus vaccine (Rotarix) in children during the first 6 months of age.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 21, 2007
Enrollment StartJul 3, 2007
Primary CompletionMar 31, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 19.0 years ago

Interventions

Synflorixbiological

Intramuscular injection, 3 doses.

Infanrix hexabiological

Intramuscular injection, 3 doses.

Rotarixbiological

Oral, 2 doses.