Haemophilus InfluenzaePhase 1NCT00849069
Study to Assess the Safety of a New GSK Biologicals' GSK2231395A Candidate Vaccine
A Phase 1 study testing GSK2231395A and TwinrixTM in people with Haemophilus Influenzae and Streptococcus Pneumoniae, run by GlaxoSmithKline at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Haemophilus Influenzae, Streptococcus Pneumoniae
- What is being tested?
- GSK2231395A and TwinrixTM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 12 Mar 2009to 7 Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observer-blind, Safety Study of GSK Biologicals' Haemophilus Influenzae and Streptococcus Pneumoniae Candidate Vaccine in Adults.
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
- Being tested
- GSK2231395A, TwinrixTM
- Keywords
- Streptococcus pneumoniae, Vaccine, Non-typable Haemophilus influenza, Adults and Elderly Adults
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2231395ABiological
3 doses intramuscular injections
TwinrixTMBiological
3 doses intramuscular injections
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: GSK2231395A |
| Group B | Active comparator | Not described Receives: Biological: TwinrixTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence, intensity and relationship of adverse events after each vaccine dose.
Measured: Defined period in function of the measured parameter
Occurrence of any vaccine-related serious adverse events
Measured: Throughout the study
Occurrence of any adverse event of specific interest
Measured: Throughout the study
Secondary outcomes (3)
Evaluation of the disease progression of subjects receiving the candidate vaccine versus subjects receiving the comparator vaccine.
Measured: Defined time points in function of the measured parameter
Evaluation of antibody responses against candidate vaccine antigens.
Measured: 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.
Measured: Defined time points in function of the measured parameter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study start12 Mar 2009
- Primary completion7 Apr 2009
- Study completion7 Apr 2009
Why it stopped: The study has been stopped for logistic reasons not related to the safety or efficacy of the vaccine.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilus InfluenzaeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849069
- Sponsor's protocol ID
- 112350
- Status last verified
- Oct 2017
- First submitted
- 19 Feb 2009
- Last updated
- 31 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observer-blind, Safety Study of GSK Biologicals' Haemophilus Influenzae and Streptococcus Pneumoniae Candidate Vaccine in Adults.
- ClinicalTrials.gov ID
- NCT00849069
- Acronym / sponsor ID
- 112350
- Conditions
- Haemophilus Influenzae, Streptococcus Pneumoniae
- Keywords
- Streptococcus pneumoniae, Vaccine, Non-typable Haemophilus influenza, Adults and Elderly Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been stopped for logistic reasons not related to the safety or efficacy of the vaccine.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2009 (actual)
- Primary completion
- 7 Apr 2009 (actual)
- Study completion
- 7 Apr 2009 (actual)
- First posted
- 23 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: GSK2231395A |
| Group B | Active comparator | Biological: TwinrixTM |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK2231395A3 doses intramuscular injections | Biological | Group A |
| TwinrixTM3 doses intramuscular injections | Biological | Group B |
Primary outcome
Occurrence, intensity and relationship of adverse events after each vaccine dose.
Time frame: Defined period in function of the measured parameter
Occurrence of any vaccine-related serious adverse events
Time frame: Throughout the study
Occurrence of any adverse event of specific interest
Time frame: Throughout the study
3 secondary outcomes
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
Evaluation of antibody responses against candidate vaccine antigens.
Time frame: 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.
Time frame: Defined time points in function of the measured parameter
Results and safety
The study was stopped early (reason given: The study has been stopped for logistic reasons not related to the safety or efficacy of the vaccine.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK2231395A and TwinrixTM in people with Haemophilus Influenzae and Streptococcus Pneumoniae, run by GlaxoSmithKline at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study has been stopped for logistic reasons not related to the safety or efficacy of the vaccine.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence, intensity and relationship of adverse events after each vaccine dose. (time frame: Defined period in function of the measured parameter). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.