NCT01678677

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Current and Former Smokers

An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Current and Former Smokers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of 8 different formulations of investigational NTHI vaccine in current and former smokers, 50-70 years of age.

Detailed description

This Protocol Posting has been updated following Protocol Amendment 1, dated 10 October 2012, leading to a change in an inclusion criterion.

Conditions

• Respiratory Disorders

Interventions

Type	Name	Description
BIOLOGICAL	NTHI vaccine GSK2838500A (formulation 1)	Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
BIOLOGICAL	NTHI vaccine GSK2838501A (formulation 2)	Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
BIOLOGICAL	NTHI vaccine GSK2838502A (formulation 3)	Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
BIOLOGICAL	NTHI vaccine GSK2838503A (formulation 4)	Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
BIOLOGICAL	NTHI vaccine GSK2838504A (formulation 5)	Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
BIOLOGICAL	NTHI vaccine GSK2838505A (formulation 6)	Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
BIOLOGICAL	NTHI vaccine GSK2838508A (formulation 7)	Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
BIOLOGICAL	NTHI vaccine GSK2838509A (formulation 8)	Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
DRUG	Placebo comparator	Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Timeline

• Start date: 2012-08-31
• Primary completion: 2014-01-30
• Completion: 2014-01-30
• First posted: 2012-09-05
• Last updated: 2017-05-15

Locations

3 sites across 1 country: Belgium