InfluenzaPhase 3NCT00866580
A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine
A Phase 3 study testing GSK's candidate influenza vaccine 1562902A and FluarixTM in people with Influenza, run by GlaxoSmithKline at 1 site in Brazil.
Trial summary
This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population. Read more about this study
- Who is it for?
- Ages 61 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GSK's candidate influenza vaccine 1562902A and FluarixTM
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- May 2010to Jul 2011
- Phase
- Phase 3
- 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 61 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 61 years or above at the time of the first study visit (Day -30).
- Female subjects of non-childbearing potential.
- Healthy subjects or subjects with well controlled chronic medical condition (at the discretion of the investigator).
- Written informed consent obtained from the subject.
- Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Who cannot join
- Previous administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ .
- Previous administration of the 2009 Southern Hemisphere or 2008-2009 Northern Hemisphere influenza vaccine.
- Previous administration of a pandemic influenza vaccine.
- Administration of licensed vaccines within 4 weeks prior to enrolment in this study.
- Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first study vaccination.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of chronic alcohol consumption and/or drug abuse.
- History of hypersensitivity to vaccines.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Acute disease and/or fever at the time of enrolment.
- Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination..
- Administration of immunoglobulins and/or any blood products within the three months preceding the first study vaccination or during the study.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to the first vaccination, or planned use during the study period.
- Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine GSK 1562902A.
This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.
- Conditions
- Influenza
- Being tested
- GSK's candidate influenza vaccine 1562902A, FluarixTM, Placebo
- Keywords
- Pandemic influenza
- 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's candidate influenza vaccine 1562902ABiological
Intramuscular dose on Day 0 and Day 21
FluarixTMBiological
Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule
PlaceboBiological
Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: GSK's candidate influenza vaccine 1562902A; Biological: FluarixTM; Biological: Placebo |
| Group B | Experimental | Not described Receives: Biological: GSK's candidate influenza vaccine 1562902A; Biological: FluarixTM; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum HI antibody titres
Measured: Day -30, Day 42
Secondary outcomes (6)
Serum HI antibody titres
Measured: Day -30, Day 42, Month 6, Month 12
Serum neutralising antibody titres
Measured: Day -30, Day 42, Month 6, Month 12
Occurrence, intensity, and relationship to vaccination of solicited local and general signs and symptoms
Measured: Day 0 - Day 6 after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited adverse events
Measured: Day 0 - Day 29 after vaccination, Day 0 - Day 20 after investigational vaccination
Occurrence and relationship to vaccination of serious adverse events
Measured: Day 0 - Month 6
Occurrence of adverse events of specific interest
Measured: Day 0 - Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startMay 2010
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
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
- NCT00866580
- Sponsor's protocol ID
- 112865
- Status last verified
- Mar 2015
- First submitted
- 19 Mar 2009
- 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
- Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine GSK 1562902A.
- ClinicalTrials.gov ID
- NCT00866580
- Acronym / sponsor ID
- 112865
- Conditions
- Influenza
- Keywords
- Pandemic influenza
- Phase
- Phase 3
- 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)
- Study start
- May 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 20 Mar 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.
This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: GSK's candidate influenza vaccine 1562902A, Biological: FluarixTM, Biological: Placebo |
| Group B | Experimental | Biological: GSK's candidate influenza vaccine 1562902A, Biological: FluarixTM, Biological: Placebo |
Who may qualify
- Ages
- 61 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects aged 61 years or above at the time of the first study visit (Day -30).
- Female subjects of non-childbearing potential.
- Healthy subjects or subjects with well controlled chronic medical condition (at the discretion of the investigator).
- Written informed consent obtained from the subject.
- Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
Key exclusion criteria (16 listed)
- Previous administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ .
- Previous administration of the 2009 Southern Hemisphere or 2008-2009 Northern Hemisphere influenza vaccine.
- Previous administration of a pandemic influenza vaccine.
- Administration of licensed vaccines within 4 weeks prior to enrolment in this study.
- Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine.
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's candidate influenza vaccine 1562902AIntramuscular dose on Day 0 and Day 21 | Biological | Group A, Group B |
| FluarixTMIntramuscular dose on Day 42 or on Day -30, according to the vaccination schedule | Biological | Group A, Group B |
| PlaceboIntramuscular dose on Day 42 or on Day -30, according to the vaccination schedule | Biological | Group A, Group B |
Primary outcome
Serum HI antibody titres
Time frame: Day -30, Day 42
6 secondary outcomes
Serum HI antibody titres
Time frame: Day -30, Day 42, Month 6, Month 12
Serum neutralising antibody titres
Time frame: Day -30, Day 42, Month 6, Month 12
Occurrence, intensity, and relationship to vaccination of solicited local and general signs and symptoms
Time frame: Day 0 - Day 6 after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited adverse events
Time frame: Day 0 - Day 29 after vaccination, Day 0 - Day 20 after investigational vaccination
Occurrence and relationship to vaccination of serious adverse events
Time frame: Day 0 - Month 6
Occurrence of adverse events of specific interest
Time frame: Day 0 - Month 12
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK's candidate influenza vaccine 1562902A and FluarixTM in people with Influenza, run by GlaxoSmithKline at 1 site in Brazil.
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 6 inclusion and 16 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 1 site in Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Serum HI antibody titres (time frame: Day -30, Day 42). 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.