InfluenzaPhase 2NCT00540228
Study to Evaluate an Influenza Vaccine Candidate
A Phase 2 study testing Influenza Vaccine GSK1247446A - 4 different formulations and Fluarix™ in people with Influenza, run by GlaxoSmithKline at 15 sites in 3 countries.
Trial summary
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza Vaccine GSK1247446A - 4 different formulations and Fluarix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,006 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 5 Oct 2007to 8 May 2008
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Only subjects who the investigator believes that they can and will comply with the requirements of the protocol .
- A male or female between, and including, 18 - 64 years of age at the time of vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must have a negative pregnancy test, practice adequate contraception for 30 days prior to vaccination, and continue such precautions for 2 months after completion of the vaccination series.
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 first dose of 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 three months prior to the first vaccine dose
- Administration of a vaccine not foreseen by the study protocol from 30 days before vaccination, up to 21 days after vaccination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s)
Show all 17Show fewer
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Confirmed influenza infection within a year preceding the study start.
- Administration of an influenza vaccine within a year preceding the study start.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
- Acute disease at the time of enrolment.
- History of chronic alcohol consumption and/or drug abuse.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- History of administration of experimental/licensed vaccine containing squalene and/or tocopherol within the last 12 months.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
France6 sites
GSK Investigational Site
Caen, 14052
GSK Investigational Site
Lagord, 17140
GSK Investigational Site
Lille, 59019
GSK Investigational Site
Paris, 75679
GSK Investigational Site
Paris, 75877
GSK Investigational Site
Toulouse, 31300
Germany5 sites
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Freiberg, Saxony, 09599
GSK Investigational Site
Schmiedeberg, Saxony, 01762
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72074
GSK Investigational Site
Würzburg, Bavaria, 97070
Spain4 sites
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Madrid, 28035
GSK Investigational Site
Madrid, 28040
About this study
Official title: Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza Vaccine GSK1247446A With Various Formulations in Subjects Aged 18-64 Years
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.
Read the detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Conditions
- Influenza
- Being tested
- Influenza Vaccine GSK1247446A - 4 different formulations, Fluarix™
- Keywords
- Influenza, Influenza Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Vaccine GSK1247446A - 4 different formulationsBiological
Single dose, Intramuscular injection
Fluarix™Biological
Single dose, Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| GSK1247446A 1 Group | Experimental | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Influenza Vaccine GSK1247446A - 4 different formulations |
| GSK1247446A 2 Group | Experimental | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Influenza Vaccine GSK1247446A - 4 different formulations |
| GSK1247446A 3 Group | Experimental | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Influenza Vaccine GSK1247446A - 4 different formulations |
| GSK1247446A 4 Group | Experimental | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Influenza Vaccine GSK1247446A - 4 different formulations |
| Fluarix Group | Active comparator | Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Fluarix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.
Measured: At Days 0, 21 and 180
Secondary outcomes (11)
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 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Measured: At Days 21 and 180
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Measured: At Days 21 and 180
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Measured: At Days 0, 21 and 180
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28.
Measured: At Days 0 and 21
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
The mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).
Measured: At Days 0, 21 and 180
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
The mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).
Measured: At Days 0, 21 and 180
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site.
Measured: During the 7-day (Days 0-6) post vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature above (>) 38.0 degrees Celsius (°C)], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Measured: During the 7-day (Days 0-6) post vaccination period
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).
MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination
Measured: From Day 0 to Day 180
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.
Measured: During the 21-day (Days 0-20) post vaccination period
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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Day 0 to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study start5 Oct 2007
- Primary completion8 May 2008
- Study completion8 May 2008
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,006 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
- NCT00540228
- Sponsor's protocol ID
- 110794
- Other IDs
- 2007-003776-18
- Status last verified
- Jun 2019
- First submitted
- 4 Oct 2007
- Last updated
- 14 Jun 2019
- 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 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza Vaccine GSK1247446A With Various Formulations in Subjects Aged 18-64 Years
- ClinicalTrials.gov ID
- NCT00540228
- Acronym / sponsor ID
- 110794
- Conditions
- Influenza
- Keywords
- Influenza, Influenza Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,006 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2007 (actual)
- Primary completion
- 8 May 2008 (actual)
- Study completion
- 8 May 2008 (actual)
- First posted
- 5 Oct 2007 (estimated)
- Results
- Posted 30 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GSK1247446A 1 Group | Experimental | Biological: Influenza Vaccine GSK1247446A - 4 different formulationsSubjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK1247446A 2 Group | Experimental | Biological: Influenza Vaccine GSK1247446A - 4 different formulationsSubjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK1247446A 3 Group | Experimental | Biological: Influenza Vaccine GSK1247446A - 4 different formulationsSubjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK1247446A 4 Group | Experimental | Biological: Influenza Vaccine GSK1247446A - 4 different formulationsSubjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix Group | Active comparator | Biological: Fluarix™Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Only subjects who the investigator believes that they can and will comply with the requirements of the protocol .
- A male or female between, and including, 18 - 64 years of age at the time of vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must have a negative pregnancy test, practice adequate contraception for 30 days prior to vaccination, and continue such precautions for 2 months after completion of the vaccination series.
Key exclusion criteria (17 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of 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 three months prior to the first vaccine dose
- Administration of a vaccine not foreseen by the study protocol from 30 days before vaccination, up to 21 days after vaccination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
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 |
|---|---|---|
| Influenza Vaccine GSK1247446A - 4 different formulationsSingle dose, Intramuscular injection | Biological | GSK1247446A 1 Group, GSK1247446A 2 Group, GSK1247446A 3 Group, GSK1247446A 4 Group |
| Fluarix™Single dose, Intramuscular injection | Biological | Fluarix Group |
Primary outcome
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Time frame: At Days 0, 21 and 180
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.
11 secondary outcomes
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
Time frame: At Days 21 and 180
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Time frame: At Days 21 and 180
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
Time frame: At Days 0, 21 and 180
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Time frame: At Days 0 and 21
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Time frame: At Days 0, 21 and 180
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
Time frame: At Days 0, 21 and 180
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Time frame: During the 7-day (Days 0-6) post vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Time frame: During the 7-day (Days 0-6) post vaccination period
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).
Time frame: From Day 0 to Day 180
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Time frame: During the 21-day (Days 0-20) post vaccination period
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: From Day 0 to Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- 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
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Influenza Vaccine GSK1247446A - 4 different formulations and Fluarix™ in people with Influenza, run by GlaxoSmithKline at 15 sites in 3 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 5 inclusion and 17 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 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Germany, Spain. 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 30 Apr 2013). 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?
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. (time frame: At Days 0, 21 and 180). 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 14 Jun 2019.