InfluenzaPhase 2NCT01045564
Safety and Immunogenicity of Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure
A Phase 2 study testing GSK influenza virus H5N1 vaccine 1557484A in people with Influenza, run by GlaxoSmithKline at 3 sites in United States.
Trial summary
The purpose of this study is to characterize the immunogenicity and safety of 3 doses of GSK's avian flu vaccine GSK 1557484A given at different time intervals to adults aged 18 years or greater who are at increased occupational risk of H5N1 exposure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GSK influenza virus H5N1 vaccine 1557484A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2011to Feb 2013
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A male or female 18 years of age or greater at the time of the first vaccination.
- At increased risk of occupational exposure to H5N1 influenza viruses based on:
- Exposure to diseased poultry or wild birds,
- Exposure, or potential exposure, to human cases of unidentified respiratory disease or known avian influenza,
- Handling of human or avian microbiological specimens,
- Handling of H5N1 viral isolates,
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- Or status critical to the implementation of emergency response measures in the event of an influenza pandemic declaration.
- Written informed consent obtained from the subject.
- Stable health status as defined by absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one (1) month prior to enrollment.
- Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
Who cannot join
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence of an oral temperature >= 37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
- Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll within 3 years of diagnosis, but other histologic types of skin cancer require a 3 year untreated and disease-free window as above.
- Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
- Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination, are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
- Administration of any vaccines within 30 days before any study vaccination.
- Exposure to any investigational or non-registered product (drug or vaccine) during this trial, or within 30 days prior to study enrollment. Potential subjects in the follow-up (i.e., no treatment) phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study; and that it does not violate the protocol requirements of the prior trial.
- Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- Receipt of analgesic or antipyretic medication with the specific intent of prophylaxis of vaccine reactogenicity on the day of treatment constitutes a contraindication to administration of study vaccine at that point in time;
- Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result prior to any vaccination.
- Lactating or nursing.
- Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
- Reliable contraceptive practices include:
- consistent abstinence from heterosexual activity,
- consistent use of combined or progestogen oral contraceptives,
- injectable progestogen,
- implants of levonorgestrel,
- estrogen or estrogen/ progestogen vaginal ring,
- percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS),
- vasectomy with documented azoospermia of >= 6 months of the sole male partner, or
- double barrier method (condom or occlusive cap plus spermicidal agent).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
GSK Investigational Site
Atlanta, Georgia, 30329-4018
GSK Investigational Site
Bethesda, Maryland, 20892-1584
GSK Investigational Site
Silver Spring, Maryland, 20910
About this study
Official title: Safety and Immunogenicity of GSK 15574484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure
The purpose of this study is to characterize the immunogenicity and safety of 3 doses of GSK's avian flu vaccine GSK 1557484A given at different time intervals to adults aged 18 years or greater who are at increased occupational risk of H5N1 exposure.
- Conditions
- Influenza
- Being tested
- GSK influenza virus H5N1 vaccine 1557484A
- Keywords
- Immunogenicity, Vaccines, H5N1, Influenza, Pandemic, Human, Avian, Safety
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK influenza virus H5N1 vaccine 1557484ABiological
Three doses of GSK 1557484A administered intramuscularly (IM), the first and third in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | One dose of study vaccine (GSK 1557484A) on Day 0, Day 182, and Day 364 Receives: Biological: GSK influenza virus H5N1 vaccine 1557484A |
| B | Experimental | One dose of study vaccine (GSK 1557484A) on Day 0, Day 91, and Day 364 Receives: Biological: GSK influenza virus H5N1 vaccine 1557484A |
| C | Experimental | One dose of study vaccine (GSK 1557484A) on Day 0, Day 21, and Day 364 Receives: Biological: GSK influenza virus H5N1 vaccine 1557484A |
| D | Experimental | One dose of study vaccine (GSK 1557484A) on Day 0, Day 21, and Day 364 Receives: Biological: GSK influenza virus H5N1 vaccine 1557484A |
| E | Experimental | One dose of study vaccine (GSK 1557484A) on Day 0, Day 21, and Day 364 Receives: Biological: GSK influenza virus H5N1 vaccine 1557484A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Booster humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies (after second vaccination).
Measured: Day 0 and 21 days after the second vaccination
Secondary outcomes (7)
Booster humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies.on secondary readouts (after second vaccination)
Measured: Days 0 and 21 days after second vaccination
Primary humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies (after first vaccination)
Measured: Days 0, 21 and 42 after first vaccination (depending on vaccination schedule)
Humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies (after third vaccination)
Measured: Days 364, 385, and 546
Humoral immune response in terms of microneutralization titers and cellular T-cell immune response
Measured: Days 0, 21, 21 days after second vaccination, 364, 385, and 546 (depending on vaccination schedule)
Occurrence of specifically-solicited local and general signs and symptoms
Measured: During a 7-day follow up period after each vaccine dose
Occurrence of all unsolicited adverse events
Measured: During a 21-day follow up period after each vaccine dose
Occurrence of serious adverse events and adverse events of special interest
Measured: From day 0 through day 546
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJan 2011
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Why it stopped: Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Health and Human Services, Center for Disease Control and Prevention, National Institutes of Health, Department of Defense
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045564
- Sponsor's protocol ID
- 112576
- Status last verified
- Mar 2015
- First submitted
- 7 Jan 2010
- Last updated
- 23 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of GSK 15574484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure
- ClinicalTrials.gov ID
- NCT01045564
- Acronym / sponsor ID
- 112576
- Conditions
- Influenza
- Keywords
- Immunogenicity, Vaccines, H5N1, Influenza, Pandemic, Human, Avian, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Health and Human Services, Center for Disease Control and Prevention, National Institutes of Health, Department of Defense
- Study start
- Jan 2011
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 11 Jan 2010 (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 characterize the immunogenicity and safety of 3 doses of GSK's avian flu vaccine GSK 1557484A given at different time intervals to adults aged 18 years or greater who are at increased occupational risk of H5N1 exposure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: GSK influenza virus H5N1 vaccine 1557484AOne dose of study vaccine (GSK 1557484A) on Day 0, Day 182, and Day 364 |
| B | Experimental | Biological: GSK influenza virus H5N1 vaccine 1557484AOne dose of study vaccine (GSK 1557484A) on Day 0, Day 91, and Day 364 |
| C | Experimental | Biological: GSK influenza virus H5N1 vaccine 1557484AOne dose of study vaccine (GSK 1557484A) on Day 0, Day 21, and Day 364 |
| D | Experimental | Biological: GSK influenza virus H5N1 vaccine 1557484AOne dose of study vaccine (GSK 1557484A) on Day 0, Day 21, and Day 364 |
| E | Experimental | Biological: GSK influenza virus H5N1 vaccine 1557484AOne dose of study vaccine (GSK 1557484A) on Day 0, Day 21, and Day 364 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A male or female 18 years of age or greater at the time of the first vaccination.
- At increased risk of occupational exposure to H5N1 influenza viruses based on:
- Written informed consent obtained from the subject.
- Stable health status as defined by absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one (1) month prior to enrollment.
- Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
Key exclusion criteria (27 listed)
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence of an oral temperature >= 37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
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 |
|---|---|---|
| GSK influenza virus H5N1 vaccine 1557484AThree doses of GSK 1557484A administered intramuscularly (IM), the first and third in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm | Biological | A, B, C, D, E |
Primary outcome
Booster humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies (after second vaccination).
Time frame: Day 0 and 21 days after the second vaccination
7 secondary outcomes
Booster humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies.on secondary readouts (after second vaccination)
Time frame: Days 0 and 21 days after second vaccination
Primary humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies (after first vaccination)
Time frame: Days 0, 21 and 42 after first vaccination (depending on vaccination schedule)
Humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies (after third vaccination)
Time frame: Days 364, 385, and 546
Humoral immune response in terms of microneutralization titers and cellular T-cell immune response
Time frame: Days 0, 21, 21 days after second vaccination, 364, 385, and 546 (depending on vaccination schedule)
Occurrence of specifically-solicited local and general signs and symptoms
Time frame: During a 7-day follow up period after each vaccine dose
Occurrence of all unsolicited adverse events
Time frame: During a 21-day follow up period after each vaccine dose
Occurrence of serious adverse events and adverse events of special interest
Time frame: From day 0 through day 546
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK influenza virus H5N1 vaccine 1557484A in people with Influenza, run by GlaxoSmithKline at 3 sites in United States.
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 10 inclusion and 27 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: withdrawn, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Booster humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies (after second vaccination). (time frame: Day 0 and 21 days after the second vaccination). 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 23 Mar 2015.