Back to resultsSafety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population
Primary Purpose
Influenza, Influenza Vaccines
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
SB218352_15
SB218352_8
SB218352_4
SB218352_2
SB218352_8AL
SB218352_4AL
SB218352_2AL
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring prophylaxis of pandemic influenza
Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
SB218352_15 Group
SB218352_8 Group
SB218352_4 Group
SB218352_2 Group
SB218352_8AL Group
SB218352_4AL Group
SB218352_2AL Group
Arm Description
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.
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.
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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).
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).
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
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
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.
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.
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.
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.
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.
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.
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).
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).
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
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
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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).
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).
Frequency of Antigen-specific CD4 T-cells
Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
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.
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).
Frequency of Antigen-specific CD8 T-cells
Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
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.
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).
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).
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.
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.
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.
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.
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.
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).
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00306995
Brief Title
Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 11, 2005 (Actual)
Primary Completion Date
July 4, 2006 (Actual)
Study Completion Date
July 4, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Influenza Vaccines
Keywords
prophylaxis of pandemic influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
385 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SB218352_15 Group
Arm Type
Experimental
Arm Description
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.
Arm Title
SB218352_8 Group
Arm Type
Experimental
Arm Description
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.
Arm Title
SB218352_4 Group
Arm Type
Experimental
Arm Description
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.
Arm Title
SB218352_2 Group
Arm Type
Experimental
Arm Description
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.
Arm Title
SB218352_8AL Group
Arm Type
Experimental
Arm Description
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.
Arm Title
SB218352_4AL Group
Arm Type
Experimental
Arm Description
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.
Arm Title
SB218352_2AL Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
SB218352_15
Intervention Description
Non-adjuvanted pandemic influenza A formulation 1 vaccine
Intervention Type
Biological
Intervention Name(s)
SB218352_8
Intervention Description
Non-adjuvanted pandemic influenza A formulation 2 vaccine
Intervention Type
Biological
Intervention Name(s)
SB218352_4
Intervention Description
Non-adjuvanted pandemic influenza A formulation 3 vaccine
Intervention Type
Biological
Intervention Name(s)
SB218352_2
Intervention Description
Non-adjuvanted pandemic influenza A formulation 4 vaccine
Intervention Type
Biological
Intervention Name(s)
SB218352_8AL
Intervention Description
Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine
Intervention Type
Biological
Intervention Name(s)
SB218352_4AL
Intervention Description
Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine
Intervention Type
Biological
Intervention Name(s)
SB218352_2AL
Intervention Description
Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine
Primary Outcome Measure Information:
Title
Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Description
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Time Frame
At Day 10 post Dose 1
Title
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Description
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Time Frame
At Day 21 post Dose 1
Title
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Description
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
Time Frame
At Day 10 post Dose 1
Title
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Description
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
Time Frame
At Day 21 post Dose 1
Title
Seroconversion Factor for Influenza A Subtype H9N2
Description
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 10 compared to day 0.
Time Frame
At Day 10 post Dose 1
Title
Seroconversion Factor for Influenza A Subtype H9N2
Description
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 compared to day 0.
Time Frame
At Day 21 post Dose 1
Title
Number of Seroprotected Subjects Against H9N2
Description
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.
Time Frame
At Day 10 post Dose 1
Title
Number of Seroprotected Subjects Against H9N2
Description
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.
Time Frame
At Day 21 post Dose 1
Title
Number of Subjects With Seroprotection Power Against H9N2
Description
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.
Time Frame
At Day 10 post Dose 1
Title
Number of Subjects With Seroprotection Power Against H9N2
Description
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.
Time Frame
At Day 21 post Dose 1
Title
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Description
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Time Frame
At Day 21 post Dose 2 (Day 42)
Title
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Description
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Time Frame
At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Title
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Description
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
Time Frame
At Day 21 post Dose 2 (Day 42)
Title
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Description
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
Time Frame
At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Title
Seroconversion Factor for Influenza A Subtype H9N2
Description
Seroconversion factor defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 42) compared to day 0.
Time Frame
At Day 21 post Dose 2 (Day 42)
Title
Seroconversion Factor for Influenza A Subtype H9N2
Description
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.
Time Frame
At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Title
Number of Seroprotected Subjects Against H9N2
Description
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.
Time Frame
At Day 21 post Dose 2 (Day 42)
Title
Number of Seroprotected Subjects Against H9N2
Description
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.
Time Frame
At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Title
Number of Subjects With Seroprotection Power Against H9N2
Description
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.
Time Frame
At Day 21 post Dose 2 (Day 42)
Title
Number of Subjects With Seroprotection Power Against H9N2
Description
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.
Time Frame
At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Secondary Outcome Measure Information:
Title
Number of Subjects With Unsolicited Adverse Events (AEs)
Description
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.
Time Frame
During the 30-days (Day 0-30) post vaccination
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
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).
Time Frame
From Day 0 to Day 51
Title
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
Description
Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L).
Time Frame
At Days 0, 10, 21 and 42 post vaccination
Title
Frequency of Antigen-specific CD4 T-cells
Description
Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
Time Frame
At Days 0, 10, 21 and 42 post-vaccination
Title
Cytokine-positive CD4 T-cells Frequency
Description
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.
Time Frame
At Days 10, 21 and 42 post-vaccination
Title
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
Description
Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L).
Time Frame
At Days 0, 10, 21 and 42 post-vaccination
Title
Frequency of Antigen-specific CD8 T-cells
Description
Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
Time Frame
At Days 0, 10, 21 and 42 post-vaccination
Title
Cytokine-positive CD8 T-cells Frequency
Description
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.
Time Frame
At Days 10, 21 and 42 post-vaccination
Title
Number of Subjects With Solicited Local Symptoms
Description
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).
Time Frame
During the 4-days post Dose 1 (Days 0-3), post Dose 2 (Days 21-24) and across these doses
Title
Number of Subjects With Solicited Local Symptoms
Description
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).
Time Frame
During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)
Title
Number of Subjects With Solicited General Symptoms
Description
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.
Time Frame
During the 4-days (Day 0-3) post Dose 1
Title
Number of Subjects With Solicited General Symptoms
Description
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.
Time Frame
During the 4-days post Dose 2 (Days 21-24)
Title
Number of Subjects With Solicited General Symptoms
Description
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.
Time Frame
During the 4-Days (Day 0-3) across doses 1 and 2
Title
Number of Subjects With Solicited General Symptoms
Description
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.
Time Frame
During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)
Title
Number of Subjects With Unsolicited AEs
Description
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.
Time Frame
During the 30-days post Dose 3 (Days 189-219 for Subset 1 groups and Days 365-395 for Subset 2 groups)
Title
Number of Subjects With SAEs
Description
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).
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)
Title
Number of Subjects With Any SAEs
Description
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.
Time Frame
Up to 30-day post Dose 3 (Days 365-394)
Title
Number of Subjects With Antibody Persistence
Description
Antibody persistence was evaluated in terms of seroprotection rate (SPR) against influenza A subtype H9N2 and seroconversion rate (SCR) against influenza A subtype H9N2.
Time Frame
At Days 189 and 365
Title
Seroconversion Factor (SCF) for Influenza A Subtype H9N2.
Description
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.
Time Frame
At Days 189 and 365
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Finsterwalde
State/Province
Brandenburg
ZIP/Postal Code
03238
Country
Germany
Facility Name
GSK Investigational Site
City
Ketzin
State/Province
Brandenburg
ZIP/Postal Code
14669
Country
Germany
Facility Name
GSK Investigational Site
City
Tostedt
State/Province
Niedersachsen
ZIP/Postal Code
21255
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01219
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
GSK Investigational Site
City
Geringswalde
State/Province
Sachsen
ZIP/Postal Code
09326
Country
Germany
Facility Name
GSK Investigational Site
City
Schmiedeberg
State/Province
Sachsen
ZIP/Postal Code
01762
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Bramstedt
State/Province
Schleswig-Holstein
ZIP/Postal Code
24576
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Segeberg
State/Province
Schleswig-Holstein
ZIP/Postal Code
23795
Country
Germany
Facility Name
GSK Investigational Site
City
Elmshorn
State/Province
Schleswig-Holstein
ZIP/Postal Code
25335
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102499
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102499
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102499
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102499
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102499
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population
We'll reach out to this number within 24 hrs