NCT01678677View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

272

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

January 30, 2014

Study Completion Date

January 30, 2014

Conditions
Respiratory Disorders
Interventions
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.

Trial Locations (3)

2060

GSK Investigational Site, Antwerp

2610

GSK Investigational Site, Wilrijk

9000

GSK Investigational Site, Ghent

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

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 | Biotech Hunter | Biotech Hunter