NCT01641133

Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™

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™

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 457 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

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.

Detailed description

This study is partially blinded as the primary phase will be conducted in an observer-blind method and booster phase will be open method.

Conditions

• Infections, Streptococcal
• Streptococcus Pneumoniae Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Synflorix (3-Dose)	3 doses administered intramuscularly
BIOLOGICAL	Synflorix (2-Dose)	2 doses administered intramuscularly
BIOLOGICAL	Synflorix (Single Dose)	1 dose administered intramuscularly
BIOLOGICAL	Prevenar 13 (Single Dose)	1 dose administered intramuscularly
BIOLOGICAL	Prevenar 13 (2-Dose)	2 doses administered intramuscularly

Timeline

• Start date: 2012-09-04
• Primary completion: 2013-07-15
• Completion: 2014-05-07
• First posted: 2012-07-16
• Last updated: 2021-03-02
• Results posted: 2017-02-27

Locations

3 sites across 1 country: Mexico