NCT01767402

Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine in Healthy Adults

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine Without or With Adjuvant, Administered at 2 Different Concentrations According to a 0-2 Month Schedule, in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the safety, reactogenicity and immunogenicity of the GlaxoSmithKline (GSK) Biologicals candidate pneumococcal vaccine containing PhtD in healthy elderly population aged 18-45 years of age.

Detailed description

The safety profile of the PhtD vaccine will be assessed in comparison to a comparator vaccine (Pneumovax 23TM). In order to further increase the immune response to vaccination, a novel adjuvant system will also be examined.

Conditions

• Pneumococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	PhtD vaccine with/without adjuvant	Two doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2.
BIOLOGICAL	Pneumovax 23TM	One dose of Pneumovax 23TM vaccine administered intramuscularly in the deltoid region of the right arm at month 0.
BIOLOGICAL	NaCl	One dose administered intramuscularly in the deltoid region of the right arm at month 2.

Timeline

• Start date: 2003-10-01
• Primary completion: 2004-11-01
• Completion: 2004-11-01
• First posted: 2013-01-14
• Last updated: 2013-01-14

Locations

1 site across 1 country: Belgium