Trial record 13 of 186 for:    "Haemophilus influenzae"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00849069
Recruitment Status : Terminated (The study has been stopped for logistic reasons not related to the safety or efficacy of the vaccine.)
First Posted : February 23, 2009
Last Update Posted : October 31, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Haemophilus Influenzae Streptococcus Pneumoniae Biological: GSK2231395A Biological: TwinrixTM Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Observer-blind, Safety Study of GSK Biologicals' Haemophilus Influenzae and Streptococcus Pneumoniae Candidate Vaccine in Adults.
Actual Study Start Date : March 12, 2009
Actual Primary Completion Date : April 7, 2009
Actual Study Completion Date : April 7, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Group A Biological: GSK2231395A
3 doses intramuscular injections

Active Comparator: Group B Biological: TwinrixTM
3 doses intramuscular injections

Primary Outcome Measures :
  1. Occurrence, intensity and relationship of adverse events after each vaccine dose. [ Time Frame: Defined period in function of the measured parameter ]
  2. Occurrence of any vaccine-related serious adverse events [ Time Frame: Throughout the study ]
  3. Occurrence of any adverse event of specific interest [ Time Frame: Throughout the study ]

Secondary Outcome Measures :
  1. 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 ]
  2. Evaluation of antibody responses against candidate vaccine antigens. [ Time Frame: Defined time points in function of the measured parameter ]
  3. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00849069

Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00849069     History of Changes
Other Study ID Numbers: 112350
First Posted: February 23, 2009    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Immunologic Factors
Physiological Effects of Drugs