InfluenzaPhase 2NCT00318149
Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population
A Phase 2 study testing Fluarix, Fluarix-AS25 and Fluarix-AS50 in people with Influenza, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. 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?
- Fluarix, Fluarix-AS25 and Fluarix-AS50
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Oct 2005to 14 May 2006
- Phase
- Phase 2
- 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
- A male or female aged between 18 and 40 years or aged 65 years or older at the time of the vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- History of confirmed influenza infection since a year from the date of previous vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
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- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Demonstrate the Non-inferiority in Term of Cellular Mediated Immune Response of GSK Biologicals' Influenza Candidate Vaccines Containing Various Adjuvants Administered in Elderly Population (Aged 65 Years &Amp; Older) vs Fluarix™ (Known as Alpha-Rix™ in Belgium) Administered in Adults (18-40 Years)
As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a vaccination with four different adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly aged 65 years and older will receive Fluarix™ and form the control groups of this trial.
- Conditions
- Influenza
- Being tested
- Fluarix, Fluarix-AS25, Fluarix-AS50, Fluarix-AS01B, Fluarix-AS01E
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluarixBiological
Also called GlaxoSmithKline Biologicals' licensed influenza vaccine
1 dose administered intramuscularly in the deltoid region of the non-dominant arm
Fluarix-AS25Biological
Also called Fluarix vaccine adjuvanted with AS25
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
Fluarix-AS50Biological
Also called Fluarix vaccine adjuvanted with AS25
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
Fluarix-AS01BBiological
Also called Fluarix vaccine adjuvanted with AS01B
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
Fluarix-AS01EBiological
Also called Fluarix vaccine adjuvanted with AS01E
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
| Study group | Role | What they receive |
|---|---|---|
| Fluarix 18-40 Y Group | Experimental | Subjects (aged 18-40 years [Y]) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Fluarix |
| Fluarix ≥65 Y Group | Experimental | Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Fluarix |
| Fluarix-AS25 Group | Experimental | Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Fluarix-AS25 |
| Fluarix-AS50 Group | Experimental | Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Fluarix-AS50 |
| Fluarix- AS01B Group | Experimental | Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Fluarix-AS01B |
| Fluarix- AS01E Group | Experimental | Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Fluarix-AS01E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers
The frequency was expressed as the geometric mean of influenza-specific CD4 T-cells, expressing at least 2 markers among CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ ) upon in vitro stimulation.
Measured: At Day 21
Secondary outcomes (12)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Seropositivity was defined as a serum HI titer greater than or equal to (≥) 1:10.
Measured: At Day 0 and at Day 21
Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Seropositivity was defined as a serum HI titer of ≥ 1:10.
Measured: At Day 90 and Day 180
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Measured: At Day 21
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Measured: At Day 90 and Day 180
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold change in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to pre-vaccination time point. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Measured: At Day 21
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold change in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to pre-vaccination time point. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Measured: At Day 90 and Day 180
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Measured: At Day 0 and at Day 21
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Measured: At Day 90 and Day 180
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were haematoma, pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevented normal everyday activity. Grade 3 haematoma/redness/swelling = haematoma/redness/swelling spreading beyond 50 millimeters (mm).
Measured: During the 7-day (Days 0-6) follow-up period after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, joint pain, muscle aches and shivering. Any = occurrence of any general symptom regardless of intensity grade and relationship to vaccination. Grade 3 = symptoms that prevented normal activity. Grade 3 fever = fever >39°C. Related = general symptom assessed by the investigator as causally related to the study vaccination.
Measured: During the 7-day (Days 0-6) follow-up period after vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 =event that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the study vaccination.
Measured: During the 21-day (Days 0-20) follow-up period after vaccination
Number of Subjects With Serious Adverse Events (SAEs).
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period (Day 0 - Day 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2006 (estimated)
- Study start10 Oct 2005
- Primary completion14 May 2006
- Study completion14 May 2006
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.
- 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
- 425 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
- NCT00318149
- Sponsor's protocol ID
- 104886
- Status last verified
- Feb 2018
- First submitted
- 25 Apr 2006
- Last updated
- 8 Aug 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstrate the Non-inferiority in Term of Cellular Mediated Immune Response of GSK Biologicals' Influenza Candidate Vaccines Containing Various Adjuvants Administered in Elderly Population (Aged 65 Years &Amp; Older) vs Fluarix™ (Known as Alpha-Rix™ in Belgium) Administered in Adults (18-40 Years)
- ClinicalTrials.gov ID
- NCT00318149
- Acronym / sponsor ID
- 104886
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2005 (actual)
- Primary completion
- 14 May 2006 (actual)
- Study completion
- 14 May 2006 (actual)
- First posted
- 26 Apr 2006 (estimated)
- Results
- Posted 8 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a vaccination with four different adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly aged 65 years and older will receive Fluarix™ and form the control groups of this trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Fluarix 18-40 Y Group | Experimental | Biological: FluarixSubjects (aged 18-40 years [Y]) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix ≥65 Y Group | Experimental | Biological: FluarixSubjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix-AS25 Group | Experimental | Biological: Fluarix-AS25Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix-AS50 Group | Experimental | Biological: Fluarix-AS50Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix- AS01B Group | Experimental | Biological: Fluarix-AS01BSubjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix- AS01E Group | Experimental | Biological: Fluarix-AS01ESubjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A male or female aged between 18 and 40 years or aged 65 years or older at the time of the vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (9 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- History of confirmed influenza infection since a year from the date of previous vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of hypersensitivity to vaccines.
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 |
|---|---|---|
| FluarixAlso: GlaxoSmithKline Biologicals' licensed influenza vaccine1 dose administered intramuscularly in the deltoid region of the non-dominant arm | Biological | Fluarix 18-40 Y Group, Fluarix ≥65 Y Group |
| Fluarix-AS25Also: Fluarix vaccine adjuvanted with AS251 dose administered intramuscularly into the deltoid region of the non-dominant arm | Biological | Fluarix-AS25 Group |
| Fluarix-AS50Also: Fluarix vaccine adjuvanted with AS251 dose administered intramuscularly into the deltoid region of the non-dominant arm | Biological | Fluarix-AS50 Group |
| Fluarix-AS01BAlso: Fluarix vaccine adjuvanted with AS01B1 dose administered intramuscularly into the deltoid region of the non-dominant arm | Biological | Fluarix- AS01B Group |
| Fluarix-AS01EAlso: Fluarix vaccine adjuvanted with AS01E1 dose administered intramuscularly into the deltoid region of the non-dominant arm | Biological | Fluarix- AS01E Group |
Primary outcome
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers
Time frame: At Day 21
The frequency was expressed as the geometric mean of influenza-specific CD4 T-cells, expressing at least 2 markers among CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ ) upon in vitro stimulation.
12 secondary outcomes
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
Time frame: At Day 0 and at Day 21
Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease
Time frame: At Day 90 and Day 180
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
Time frame: At Day 21
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
Time frame: At Day 90 and Day 180
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
Time frame: At Day 21
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
Time frame: At Day 90 and Day 180
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
Time frame: At Day 0 and at Day 21
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
Time frame: At Day 90 and Day 180
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Time frame: During the 7-day (Days 0-6) follow-up period after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Time frame: During the 7-day (Days 0-6) follow-up period after vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Time frame: During the 21-day (Days 0-20) follow-up period after vaccination
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: During the entire study period (Day 0 - Day 180)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluarix, Fluarix-AS25 and Fluarix-AS50 in people with Influenza, run by GlaxoSmithKline at 1 site in Belgium.
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 2 inclusion and 9 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 8 Aug 2018. 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 Belgium. 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?
Yes. Results are posted in the registry (first posted 8 Aug 2018). 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?
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers (time frame: At Day 21). 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 8 Aug 2018.