InfluenzaPhase 2NCT00306995
Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population
A Phase 2 study testing SB218352_15, SB218352_8 and SB218352_4 in people with Influenza and Influenza Vaccines, run by GlaxoSmithKline at 10 sites in Germany.
Trial summary
Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Influenza, Influenza Vaccines
- What is being tested?
- SB218352_15, SB218352_8 and SB218352_4
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 10 sitesGermany
- Study dates
- 11 May 2005to 4 Jul 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol
- A male or female aged over 60 years at the time of vaccination.
- Written informed consent obtained from the subject.
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.
- Participation in an earlier study with a candidate pandemic H9N2 vaccine.
- Acute disease at the time of enrolment.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Drug and/or alcohol dependency.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, 24576
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, 23795
GSK Investigational Site
Dresden, Saxony, 01219
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Elmshorn, Schleswig-Holstein, 25335
GSK Investigational Site
Finsterwalde, Brandenburg, 03238
GSK Investigational Site
Geringswalde, Saxony, 09326
GSK Investigational Site
Ketzin, Brandenburg, 14669
GSK Investigational Site
Schmiedeberg, Saxony, 01762
GSK Investigational Site
Tostedt, Lower Saxony, 21255
About this study
Official title: A Phase III, Open, Randomized, Multicenter, Comparative Vaccination Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of a Monovalent Candidate Pandemic Influenza A Vaccine in Individuals Over 60 Years of Age
Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world. Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have been directly transmitted to humans, raising concern over the possibility of a new influenza pandemic among the world's immunologically naive populations. In order to face this kind of situation, a pandemic influenza vaccine has to be developed.
- Conditions
- Influenza, Influenza Vaccines
- Being tested
- SB218352_15, SB218352_8, SB218352_4, SB218352_2, SB218352_8AL
- Keywords
- prophylaxis of 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.
SB218352_15Biological
Non-adjuvanted pandemic influenza A formulation 1 vaccine
SB218352_8Biological
Non-adjuvanted pandemic influenza A formulation 2 vaccine
SB218352_4Biological
Non-adjuvanted pandemic influenza A formulation 3 vaccine
SB218352_2Biological
Non-adjuvanted pandemic influenza A formulation 4 vaccine
SB218352_8ALBiological
Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine
SB218352_4ALBiological
Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine
SB218352_2ALBiological
Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine
| Study group | Role | What they receive |
|---|---|---|
| SB218352_15 Group | Experimental | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. Receives: Biological: SB218352_15 |
| SB218352_8 Group | Experimental | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. Receives: Biological: SB218352_8 |
| SB218352_4 Group | Experimental | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. Receives: Biological: SB218352_4 |
| SB218352_2 Group | Experimental | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. Receives: Biological: SB218352_2 |
| SB218352_8AL Group | Experimental | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. Receives: Biological: SB218352_8AL |
| SB218352_4AL Group | Experimental | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. Receives: Biological: SB218352_4AL |
| SB218352_2AL Group | Experimental | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. Receives: Biological: SB218352_2AL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Measured: At Day 10 post Dose 1
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Measured: At Day 21 post Dose 1
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer lower than (<) 1:10 and a post-vaccination titre higher than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer
Measured: At Day 10 post Dose 1
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer
Measured: At Day 21 post Dose 1
Seroconversion Factor for Influenza A Subtype H9N2
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 10 compared to day 0.
Measured: At Day 10 post Dose 1
Seroconversion Factor for Influenza A Subtype H9N2
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 compared to day 0.
Measured: At Day 21 post Dose 1
Number of Seroprotected Subjects Against H9N2
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Measured: At Day 10 post Dose 1
Number of Seroprotected Subjects Against H9N2
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Measured: At Day 21 post Dose 1
Number of Subjects With Seroprotection Power Against H9N2
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Measured: At Day 10 post Dose 1
Number of Subjects With Seroprotection Power Against H9N2
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Measured: At Day 21 post Dose 1
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Measured: At Day 21 post Dose 2 (Day 42)
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Measured: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in postvaccination titer
Measured: At Day 21 post Dose 2 (Day 42)
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer
Measured: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Seroconversion Factor for Influenza A Subtype H9N2
Seroconversion factor defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 42) compared to day 0.
Measured: At Day 21 post Dose 2 (Day 42)
Seroconversion Factor for Influenza A Subtype H9N2
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 210 for Subset 1 and Day 386 for Subset 2) compared to day 0.
Measured: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Number of Seroprotected Subjects Against H9N2
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Measured: At Day 21 post Dose 2 (Day 42)
Number of Seroprotected Subjects Against H9N2
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Measured: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Number of Subjects With Seroprotection Power Against H9N2
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Measured: At Day 21 post Dose 2 (Day 42)
Number of Subjects With Seroprotection Power Against H9N2
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Measured: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Secondary outcomes (19)
Number of Subjects With 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.
Measured: During the 30-days (Day 0-30) post vaccination
Number of Subjects With Serious Adverse Events (SAEs)
A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization).
Measured: From Day 0 to Day 51
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L).
Measured: At Days 0, 10, 21 and 42 post vaccination
Frequency of Antigen-specific CD4 T-cells
Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
Measured: At Days 0, 10, 21 and 42 post-vaccination
Cytokine-positive CD4 T-cells Frequency
Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0.
Measured: At Days 10, 21 and 42 post-vaccination
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L).
Measured: At Days 0, 10, 21 and 42 post-vaccination
Frequency of Antigen-specific CD8 T-cells
Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
Measured: At Days 0, 10, 21 and 42 post-vaccination
Cytokine-positive CD8 T-cells Frequency
Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0.
Measured: At Days 10, 21 and 42 post-vaccination
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm).
Measured: During the 4-days post Dose 1 (Days 0-3), post Dose 2 (Days 21-24) and across these doses
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm).
Measured: During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.
Measured: During the 4-days (Day 0-3) post Dose 1
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.
Measured: During the 4-days post Dose 2 (Days 21-24)
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.
Measured: During the 4-Days (Day 0-3) across doses 1 and 2
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axilar temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = fever higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.
Measured: During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)
Number of Subjects With Unsolicited 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.
Measured: During the 30-days post Dose 3 (Days 189-219 for Subset 1 groups and Days 365-395 for Subset 2 groups)
Number of Subjects With SAEs
A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization).
Measured: Within the 365-day post-vaccination period (Days 0-364 for Subset 1 groups) and within the 395-day post-vaccination period (Days 0-394 for Subset 2 groups)
Number of Subjects With Any SAEs
A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). Only Subset 2 groups had available data for the specified time frame.
Measured: Up to 30-day post Dose 3 (Days 365-394)
Number of Subjects With Antibody Persistence
Antibody persistence was evaluated in terms of seroprotection rate (SPR) against influenza A subtype H9N2 and seroconversion rate (SCR) against influenza A subtype H9N2.
Measured: At Days 189 and 365
Seroconversion Factor (SCF) for Influenza A Subtype H9N2.
SCF was defined as the fold increase in serum HI GMTs at the post-vaccination time points compared to Day 0, for each vaccine strain.
Measured: At Days 189 and 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2006 (estimated)
- Study start11 May 2005
- Primary completion4 Jul 2006
- Study completion4 Jul 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
- 385 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
- NCT00306995
- Sponsor's protocol ID
- 102499
- Status last verified
- Feb 2020
- First submitted
- 16 Feb 2006
- Last updated
- 10 Feb 2020
- 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 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open, Randomized, Multicenter, Comparative Vaccination Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of a Monovalent Candidate Pandemic Influenza A Vaccine in Individuals Over 60 Years of Age
- ClinicalTrials.gov ID
- NCT00306995
- Acronym / sponsor ID
- 102499
- Conditions
- Influenza, Influenza Vaccines
- Keywords
- prophylaxis of pandemic influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 May 2005 (actual)
- Primary completion
- 4 Jul 2006 (actual)
- Study completion
- 4 Jul 2006 (actual)
- First posted
- 27 Mar 2006 (estimated)
- Results
- Posted 10 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world. Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have been directly transmitted to humans, raising concern over the possibility of a new influenza pandemic among the world's immunologically naive populations. In order to face this kind of situation, a pandemic influenza vaccine has to be developed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| SB218352_15 Group | Experimental | Biological: SB218352_15Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
| SB218352_8 Group | Experimental | Biological: SB218352_8Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
| SB218352_4 Group | Experimental | Biological: SB218352_4Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
| SB218352_2 Group | Experimental | Biological: SB218352_2Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
| SB218352_8AL Group | Experimental | Biological: SB218352_8ALMale and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
| SB218352_4AL Group | Experimental | Biological: SB218352_4ALMale and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
| SB218352_2AL Group | Experimental | Biological: SB218352_2ALMale and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol
- A male or female aged over 60 years at the time of vaccination.
- Written informed consent obtained from the subject.
Key exclusion criteria (6 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.
- Participation in an earlier study with a candidate pandemic H9N2 vaccine.
- Acute disease at the time of enrolment.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
- History of allergic disease or reactions likely to be exacerbated by any component of the 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 |
|---|---|---|
| SB218352_15Non-adjuvanted pandemic influenza A formulation 1 vaccine | Biological | SB218352_15 Group |
| SB218352_8Non-adjuvanted pandemic influenza A formulation 2 vaccine | Biological | SB218352_8 Group |
| SB218352_4Non-adjuvanted pandemic influenza A formulation 3 vaccine | Biological | SB218352_4 Group |
| SB218352_2Non-adjuvanted pandemic influenza A formulation 4 vaccine | Biological | SB218352_2 Group |
| SB218352_8ALPandemic influenza A formulation 2 aluminium-adjuvanted vaccine | Biological | SB218352_8AL Group |
| SB218352_4ALPandemic influenza A formulation 3 aluminium-adjuvanted vaccine | Biological | SB218352_4AL Group |
| SB218352_2ALPandemic influenza A formulation 4 aluminium-adjuvanted vaccine | Biological | SB218352_2AL Group |
Primary outcome
Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Time frame: At Day 10 post Dose 1
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Time frame: At Day 21 post Dose 1
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Time frame: At Day 10 post Dose 1
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer lower than (<) 1:10 and a post-vaccination titre higher than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Time frame: At Day 21 post Dose 1
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer
Seroconversion Factor for Influenza A Subtype H9N2
Time frame: At Day 10 post Dose 1
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 10 compared to day 0.
Seroconversion Factor for Influenza A Subtype H9N2
Time frame: At Day 21 post Dose 1
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 compared to day 0.
Number of Seroprotected Subjects Against H9N2
Time frame: At Day 10 post Dose 1
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Number of Seroprotected Subjects Against H9N2
Time frame: At Day 21 post Dose 1
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Number of Subjects With Seroprotection Power Against H9N2
Time frame: At Day 10 post Dose 1
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Number of Subjects With Seroprotection Power Against H9N2
Time frame: At Day 21 post Dose 1
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Time frame: At Day 21 post Dose 2 (Day 42)
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Time frame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Time frame: At Day 21 post Dose 2 (Day 42)
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in postvaccination titer
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Time frame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer
Seroconversion Factor for Influenza A Subtype H9N2
Time frame: At Day 21 post Dose 2 (Day 42)
Seroconversion factor defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 42) compared to day 0.
Seroconversion Factor for Influenza A Subtype H9N2
Time frame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 210 for Subset 1 and Day 386 for Subset 2) compared to day 0.
Number of Seroprotected Subjects Against H9N2
Time frame: At Day 21 post Dose 2 (Day 42)
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Number of Seroprotected Subjects Against H9N2
Time frame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Number of Subjects With Seroprotection Power Against H9N2
Time frame: At Day 21 post Dose 2 (Day 42)
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Number of Subjects With Seroprotection Power Against H9N2
Time frame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
19 secondary outcomes
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 30-days (Day 0-30) post vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Day 0 to Day 51
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
Time frame: At Days 0, 10, 21 and 42 post vaccination
Frequency of Antigen-specific CD4 T-cells
Time frame: At Days 0, 10, 21 and 42 post-vaccination
Cytokine-positive CD4 T-cells Frequency
Time frame: At Days 10, 21 and 42 post-vaccination
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
Time frame: At Days 0, 10, 21 and 42 post-vaccination
Frequency of Antigen-specific CD8 T-cells
Time frame: At Days 0, 10, 21 and 42 post-vaccination
Cytokine-positive CD8 T-cells Frequency
Time frame: At Days 10, 21 and 42 post-vaccination
Number of Subjects With Solicited Local Symptoms
Time frame: During the 4-days post Dose 1 (Days 0-3), post Dose 2 (Days 21-24) and across these doses
Number of Subjects With Solicited Local Symptoms
Time frame: During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)
Number of Subjects With Solicited General Symptoms
Time frame: During the 4-days (Day 0-3) post Dose 1
Number of Subjects With Solicited General Symptoms
Time frame: During the 4-days post Dose 2 (Days 21-24)
Number of Subjects With Solicited General Symptoms
Time frame: During the 4-Days (Day 0-3) across doses 1 and 2
Number of Subjects With Solicited General Symptoms
Time frame: During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)
Number of Subjects With Unsolicited AEs
Time frame: During the 30-days post Dose 3 (Days 189-219 for Subset 1 groups and Days 365-395 for Subset 2 groups)
Number of Subjects With SAEs
Time frame: Within the 365-day post-vaccination period (Days 0-364 for Subset 1 groups) and within the 395-day post-vaccination period (Days 0-394 for Subset 2 groups)
Number of Subjects With Any SAEs
Time frame: Up to 30-day post Dose 3 (Days 365-394)
Number of Subjects With Antibody Persistence
Time frame: At Days 189 and 365
Seroconversion Factor (SCF) for Influenza A Subtype H9N2.
Time frame: At Days 189 and 365
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- 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
10 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 SB218352_15, SB218352_8 and SB218352_4 in people with Influenza and Influenza Vaccines, run by GlaxoSmithKline at 10 sites in Germany.
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 3 inclusion and 6 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 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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 10 Feb 2020). 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?
Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) (time frame: At Day 10 post Dose 1). The study lists 20 primary outcomes in all. 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 10 Feb 2020.