Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study to Assess the Safety of a New GSK Biologicals' GSK2231395A Candidate Vaccine

This study has been terminated.
(The study has been stopped for logistic reasons not related to the safety or efficacy of the vaccine.)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00849069
First received: February 19, 2009
Last updated: January 22, 2011
Last verified: November 2010
  Purpose

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK2231395A candidate vaccine in adults and elderly adults with chronic obstructive pulmonary disease. Subjects will be vaccinated 3 times with an interval of respectively 2 and 10 months.


Condition Intervention Phase
Non-Typable H. Influenzae / S. Pneumoniae Infections
Haemophilus Influenzae-Streptococcus Pneumoniae Vaccine
Biological: GSK2231395A
Biological: TwinrixTM
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Observer-blind, Safety Study of GSK Biologicals' H. Influenzae and S. Pneumoniae Candidate Vaccine in Adults.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence, intensity and relationship of adverse events after each vaccine dose. [ Time Frame: Defined period in function of the measured parameter ] [ Designated as safety issue: No ]
  • Occurrence of any vaccine-related serious adverse events [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Occurrence of any adverse event of specific interest [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the disease progression of subjects receiving the candidate vaccine versus subjects receiving the comparator vaccine. [ Time Frame: Defined time points in function of the measured parameter ] [ Designated as safety issue: No ]
  • Evaluation of antibody responses against candidate vaccine antigens. [ Time Frame: Defined time points in function of the measured parameter ] [ Designated as safety issue: No ]
  • Evaluation of the clinical outcomes of subjects receiving the candidate vaccine versus subjects receiving the comparator vaccine. [ Time Frame: Defined time points in function of the measured parameter ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: GSK2231395A
3 doses intramuscular injections
Active Comparator: Group B Biological: TwinrixTM
3 doses intramuscular injections

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, 40 and 80 years of age, inclusive, at the time of consent.
  • Written informed consent obtained from the subject.
  • Subject has a confirmed history of chronic obstructive pulmonary disease exacerbations, including multiple exacerbations in the 24 months prior to Screening
  • Subject has a baseline chest X-ray obtained while untreated/off systemic corticosteroids for at least 30 days duration
  • Subject is able to perform baseline pre- and post-bronchodilator pulmonary function tests while untreated/off systemic corticosteroids for at least 30 days duration and not participating in a pulmonary rehabilitation program.
  • If the subject is female, and of childbearing potential, she agrees to use acceptable contraception and not become pregnant for the duration of the study.

Exclusion Criteria:

  • Is established by a screening pulmonary function test as having mild chronic obstructive pulmonary disease
  • Is established by both a screening PFT and clinical history as having very severe chronic obstructive pulmonary disease
  • Is diagnosed with a respiratory disorder other than chronic obstructive pulmonary disease
  • Has a primary diagnosis of asthma.
  • Is prescribed/receiving systemic antibiotics in the last 30 days.
  • Is prescribed/receiving systemic corticosteroids in the last 30 days.
  • Has chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
  • Is undergoing, planning to undergo, or has undergone in the last 6 months a pulmonary rehabilitation program.
  • Has undergone, or planning to undergo, lung transplantation and/or lung volume reduction.
  • Has chest x-ray indicating an acute pulmonary disease requiring therapy or that might interfere with the study, such as CAP, tuberculosis, or lung cancer
  • Has had pneumonia within 3 months prior to first vaccination.
  • Is receiving regular long-term oxygen therapy.
  • Has a known diagnosis of α-1 antitrypsin deficiency.
  • Has a known or suspected hypersensitivity/reaction to any components of the candidate vaccine, the comparator vaccine (Twinrix® Adult or any ingredient), and/or the bronchodilator used in the study procedures.
  • Has been previously vaccinated for Hepatitis A and/or B. As a portion of the subjects will be randomized to receive Twinrix® Adult comparator, it is important that all subjects qualify to receive Twinrix® Adult.
  • Is using any investigational or non-registered product (drug or vaccine) other than the study vaccine, within 30 days preceding the first dose of study vaccine, or planned use during the study period, or participation to another pharmaceutical/vaccine study.
  • Has administered, or is planning administration, of any vaccine not foreseen by the study protocol within 30 days of the first dose of vaccines.
  • Has administration of immunoglobulins and/or any blood products within the 3 months prior to first vaccination.
  • Has any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • Has significant disease, in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.
  • Has acute cardiac insufficiency.
  • Has inflammatory processes such as known chronic active infections (e.g. Hepatitis B, Hepatitis C).
  • Has past or current malignancies and lymphoproliferative disorders.
  • Has clinically significant hematological or biochemical abnormalities as per the judgment of the investigator.
  • Has acute disease at the time of vaccination.
  • Is a pregnant or lactating female.
  • Is female and is planning to become pregnant or planning to discontinue contraceptive precautions.
  • Has, in the opinion of the investigator, evidence of alcohol or drug abuse.
  • Has other conditions that the principal investigator judges may interfere with study findings.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849069

Locations
Belgium
GSK Investigational Site
Rixensart, Belgium, 1330
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00849069     History of Changes
Other Study ID Numbers: 112350
Study First Received: February 19, 2009
Last Updated: January 22, 2011
Health Authority: Canada: Health Canada

Keywords provided by GlaxoSmithKline:
Streptococcus pneumoniae
Vaccine
Non-typable Haemophilus influenza
Adults and Elderly Adults

Additional relevant MeSH terms:
Influenza, Human
Pneumonia
Lung Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014