NCT00652951

Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib

Non-inferiority of Co-administration of GSK Biologicals'Pneumococcal Conjugate Vaccine GSK1024850A With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 780 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a three-dose primary immunisation course during the first 6 months of life and as a booster dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two years of life will also be assessed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)	Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination
BIOLOGICAL	Infanrix™ hexa.	Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
BIOLOGICAL	Pediacel™	Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
BIOLOGICAL	Prevenar™	Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-05-12
• Completion: 2010-12-01
• First posted: 2008-04-04
• Last updated: 2019-06-26
• Results posted: 2018-12-14

Locations

1 site across 1 country: Netherlands