InfluenzaPhase 3NCT00765076
Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older
A Phase 3 study testing GSK Biologicals' influenza vaccine GSK2186877A and GSK Biologicals' Fluarix in people with Influenza, run by GlaxoSmithKline at 4 sites in 2 countries.
Trial summary
This clinical trial aims to study the immunogenicity of GSK Biologicals' influenza vaccine GSK2186877A in people aged 65 years or older. 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 Biologicals' influenza vaccine GSK2186877A and GSK Biologicals' Fluarix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 16 Oct 2008to 4 Dec 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All subjects must satisfy the following criteria at study entry:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by medical history and clinical examination before entering into the study.
- Elderly adults:
- A man or woman 65 year of age or older at the time of the first vaccination.
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- Young adults:
- Man or woman between the ages of 18 and 40 years, inclusive.
- If the subject is female, she must be of non-childbearing potential or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after vaccination.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 4 after vaccination and of an influenza vaccine other than the study vaccines up to Visit 4.
- Vaccination against influenza since February 2008 with a seasonal influenza vaccine.
- Previous vaccination in the last three years with an investigational adjuvanted vaccine candidate seasonal or pandemic influenza vaccine.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
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- History of hypersensivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg or chicken protein.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
- Any medical conditions in which intramuscular injections are contraindicated.
- Pregnant or lactating female.
- Female of childbearing age planning to become pregnant or planning to discontinue contraceptive precautions.
- Any medical condition that in the opinion of the investigator precludes the collection of blood volumes as required by the protocol.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Spain3 sites
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Marid, 28040
About this study
Official title: Observer-blind Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects
This clinical trial aims to study the immunogenicity of GSK Biologicals' influenza vaccine GSK2186877A in people aged 65 years or older.
Read the detailed description
The amendment to the protocol posting: minor change in one inclusion criterion and in one secondary outcome measure.
- Conditions
- Influenza
- Being tested
- GSK Biologicals' influenza vaccine GSK2186877A, GSK Biologicals' Fluarix
- Keywords
- Vaccine, Elderly, 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 Biologicals' influenza vaccine GSK2186877ABiological
One intramuscular injection at Day 0
GSK Biologicals' FluarixBiological
One intramuscular injection at Day 0
| Study group | Role | What they receive |
|---|---|---|
| New generation influenza vaccine GSK2186877A Group | Experimental | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 Receives: Biological: GSK Biologicals' influenza vaccine GSK2186877A |
| Fluarix elderly Group | Active comparator | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 Receives: Biological: GSK Biologicals' Fluarix |
| Fluarix young Group | Active comparator | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 Receives: Biological: GSK Biologicals' Fluarix |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers
The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)
Measured: Day 21
Secondary outcomes (15)
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers
The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.
Measured: At Day 0, 21, 42 and 180
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker
The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.
Measured: At Day 0, 21, 42 and 180
Haemagglutinin Inhibition (HI) Antibody Titers
Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains.
Measured: At Day 0, 21, 42 and 180
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains.
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10
Measured: At Day 0, 21, 42 and 180
The Number of Subjects Seroconverted to HI Antibodies
Seroconversion was defined as the number of vaccinees who had either a prevaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
Measured: At Day 21, 42 and 180
HI Antibody Seroconversion Factors
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
Measured: At Day 21, 42 and 180
The Number of Subjects Seroprotected to HI Antibodies
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Measured: At Day 0, 21, 42 and 180
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis, redness and swelling was >100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity.
Measured: Day 0 -6
Duration of Solicited Local AEs
Duration was defined as the number of days with any grade of local symptoms.
Measured: Day 0 -6
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.
Measured: Day 0 -6
Duration of Solicited General AEs
Duration was defined as number of days with any grade of general symptoms.
Measured: Day 0 -6
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom, regardless of intensity or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.
Measured: Day 0-20
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)
For each solicited and unsolicited AE the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.
Measured: Day 0-179
Number of Subjects Reporting Any AEs of Specific Interest (AESI)
AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination.
Measured: Day 0-364
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination.
Measured: Day 0-364
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study start16 Oct 2008
- Primary completion4 Dec 2009
- Study completion4 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 192 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
- NCT00765076
- Sponsor's protocol ID
- 112147
- Status last verified
- Oct 2016
- First submitted
- 1 Oct 2008
- Last updated
- 31 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Couch RB, Bayas JM, Caso C, Mbawuike IN, Lopez CN, Claeys C, El Idrissi M, Herve C, Laupeze B, Oostvogels L, Moris P. Superior antigen-specific CD4+ T-cell response with AS03-adjuvantation of a trivalent influenza vaccine in a randomised trial of adults aged 65 and older. BMC Infect Dis. 2014 Jul 30;14:425. doi: 10.1186/1471-2334-14-425.
PubMed 25078387
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observer-blind Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects
- ClinicalTrials.gov ID
- NCT00765076
- Acronym / sponsor ID
- 112147
- Conditions
- Influenza
- Keywords
- Vaccine, Elderly, Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2008
- Primary completion
- 4 Dec 2009 (actual)
- Study completion
- 4 Dec 2009 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Posted 5 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to study the immunogenicity of GSK Biologicals' influenza vaccine GSK2186877A in people aged 65 years or older.
Detailed description
The amendment to the protocol posting: minor change in one inclusion criterion and in one secondary outcome measure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| New generation influenza vaccine GSK2186877A Group | Experimental | Biological: GSK Biologicals' influenza vaccine GSK2186877ASubjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 |
| Fluarix elderly Group | Active comparator | Biological: GSK Biologicals' FluarixSubjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Fluarix young Group | Active comparator | Biological: GSK Biologicals' FluarixSubjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by medical history and clinical examination before entering into the study.
- A man or woman 65 year of age or older at the time of the first vaccination.
- Man or woman between the ages of 18 and 40 years, inclusive.
Key exclusion criteria (15 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 4 after vaccination and of an influenza vaccine other than the study vaccines up to Visit 4.
- Vaccination against influenza since February 2008 with a seasonal influenza vaccine.
- Previous vaccination in the last three years with an investigational adjuvanted vaccine candidate seasonal or pandemic influenza vaccine.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
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 Biologicals' influenza vaccine GSK2186877AOne intramuscular injection at Day 0 | Biological | New generation influenza vaccine GSK2186877A Group |
| GSK Biologicals' FluarixOne intramuscular injection at Day 0 | Biological | Fluarix elderly Group, Fluarix young Group |
Primary outcome
The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers
Time frame: Day 21
The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)
15 secondary outcomes
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers
Time frame: At Day 0, 21, 42 and 180
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker
Time frame: At Day 0, 21, 42 and 180
Haemagglutinin Inhibition (HI) Antibody Titers
Time frame: At Day 0, 21, 42 and 180
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains.
Time frame: At Day 0, 21, 42 and 180
The Number of Subjects Seroconverted to HI Antibodies
Time frame: At Day 21, 42 and 180
HI Antibody Seroconversion Factors
Time frame: At Day 21, 42 and 180
The Number of Subjects Seroprotected to HI Antibodies
Time frame: At Day 0, 21, 42 and 180
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Time frame: Day 0 -6
Duration of Solicited Local AEs
Time frame: Day 0 -6
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Time frame: Day 0 -6
Duration of Solicited General AEs
Time frame: Day 0 -6
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Time frame: Day 0-20
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)
Time frame: Day 0-179
Number of Subjects Reporting Any AEs of Specific Interest (AESI)
Time frame: Day 0-364
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Time frame: Day 0-364
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25078387Couch RB, Bayas JM, Caso C, Mbawuike IN, Lopez CN, Claeys C, El Idrissi M, Herve C, Laupeze B, Oostvogels L, Moris P. Superior antigen-specific CD4+ T-cell response with AS03-adjuvantation of a trivalent influenza vaccine in a randomised trial of adults aged 65 and older. BMC Infect Dis. 2014 Jul 30;14:425. doi: 10.1186/1471-2334-14-425.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK Biologicals' influenza vaccine GSK2186877A and GSK Biologicals' Fluarix in people with Influenza, run by GlaxoSmithKline at 4 sites in 2 countries.
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 9 inclusion and 15 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: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, 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 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?
Yes. Results are posted in the registry (first posted 5 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers (time frame: Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00765076, which also lists 1 linked publication.
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 Jul 2018.