NCT00609492

Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.

Safety, Reactogenicity and Immunogenicity Following Booster Dose of GSK Biologicals´ Pneumococcal Conjugate Vaccine When Co-administered With a Booster Dose of Infanrix-IPV/Hib in Preterm Born Children at 16-18 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 16 Months – 18 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born children at the age of 16-18 months. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number =NCT00390910 ). Subjects participating in this study should have received three doses of pneumococcal vaccine in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Infections, Streptococcal
• Streptococcus Pneumoniae Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)	Single dose, intramuscular injection
BIOLOGICAL	Infanrix™-IPV/Hib	Single dose, intramuscular injection

Timeline

• Start date: 2008-01-03
• Primary completion: 2008-11-10
• Completion: 2009-03-30
• First posted: 2008-02-07
• Last updated: 2020-01-03
• Results posted: 2017-04-12

Locations

7 sites across 2 countries: Greece, Spain