CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 457 enrolled
Drug / intervention
Synflorix (3-Dose) +4 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/NCT01641133
NCT01641133Phase 3Completed

Two-dose Primary Vaccination With Either GSK Biologicals' 10-valent Pneumococcal Vaccine (Synflorix™) or Pfizer's Prevenar 13™ or Both Vaccines Followed by a Booster Dose of Synflorix™

GlaxoSmithKline·interventional·Posted Jul 16, 2012·Updated Mar 2, 2021

In Brief

A Phase 3 clinical trial evaluating Synflorix (3-Dose), Synflorix (2-Dose), and 3 other interventions for Infections, Streptococcal and Streptococcus Pneumoniae Vaccines. Completed, enrolled 457 participants across 3 sites.

Detailed Summary

The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix respectively.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2012
Enrollment StartSep 4, 2012
Primary CompletionJul 15, 2013
Study CompletionMay 7, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.0 years ago

Interventions

Synflorix (3-Dose)biological

3 doses administered intramuscularly

Synflorix (2-Dose)biological

2 doses administered intramuscularly

Synflorix (Single Dose)biological

1 dose administered intramuscularly

Prevenar 13 (Single Dose)biological

1 dose administered intramuscularly

Prevenar 13 (2-Dose)biological

2 doses administered intramuscularly