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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

NCT01678677 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2017-05-15

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-01-30
Completion
2014-01-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01678677 on ClinicalTrials.gov