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

NCT00849069 | Terminated Phase 1

• 1 other identifier: 112350
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemophilus Influenzae; Streptococcus Pneumoniae

Keywords

Streptococcus pneumoniae; Vaccine; Non-typable Haemophilus influenza; Adults and Elderly Adults

Outcome Measures

Primary Outcomes (3)

• Occurrence, intensity and relationship of adverse events after each vaccine dose.

  Defined period in function of the measured parameter

• Occurrence of any vaccine-related serious adverse events

  Throughout the study

• Occurrence of any adverse event of specific interest

  Throughout the study

Secondary Outcomes (3)

• Evaluation of the disease progression of subjects receiving the candidate vaccine versus subjects receiving the comparator vaccine.

  Defined time points in function of the measured parameter

• Evaluation of antibody responses against candidate vaccine antigens.

  Defined time points in function of the measured parameter

• Evaluation of the clinical outcomes of subjects receiving the candidate vaccine versus subjects receiving the comparator vaccine.

  Defined time points in function of the measured parameter

Study Arms (2)

Group A

EXPERIMENTAL

Biological: GSK2231395A

Group B

ACTIVE COMPARATOR

Biological: TwinrixTM

Interventions

GSK2231395A BIOLOGICAL

3 doses intramuscular injections

Group A

TwinrixTM BIOLOGICAL

3 doses intramuscular injections

Group B

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Halifax, Nova Scotia, B3K 6R8, Canada

Location

MeSH Terms

Conditions

Haemophilus Infections

Condition Hierarchy (Ancestors)

Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 23, 2009
• Study Start: March 12, 2009
• Primary Completion: April 7, 2009
• Study Completion: April 7, 2009
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

CA (1)