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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000789-39 | EudraCT Number |
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The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in adults (18 to 60 years) and in elderly (over 60 years).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluarix/Influsplit 18-60 Years Group | Experimental | Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. |
|
| Fluarix/Influsplit > 60 Years Group | Experimental | Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluarix/Influsplit SSW 2012-2013 | Biological | 1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains | Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata). | At Day 0 and Day 21 |
| Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. | Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40. | At Day 0 and Day 21 |
| Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. | A seroconverted subjects was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. | At Day 21 |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. | At Day 21 |
| Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value. | SPP was defined as the number of vaccinees with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. | At Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. | Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included H1N1, H3N2 and Yamagata antigens. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged greater than (>) 60 years. | At Day 0 and Day 21 |
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Inclusion Criteria:
Subjects who the investigator believes can and will comply with the requirements of the protocol.
A male or female aged 18 years or above at the time of vaccination.
Written informed consent obtained from the subject.
Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Dresden | Saxony | 01097 | Germany | ||
| GSK Investigational Site |
Approximately 50% of subjects in the Fluarix/Influsplit > 60 Years Group and a maximum of 25% of subjects in the Fluarix/Influsplit 18-60 Years Group were allowed to have had a seasonal influenza vaccination the year before.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluarix/Influsplit 18-60 Years Group | Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. |
| FG001 | Fluarix/Influsplit > 60 Years Group | Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluarix/Influsplit 18-60 Years Group | Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. |
| BG001 | Fluarix/Influsplit > 60 Years Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains | Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata). | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 0 and Day 21 |
|
Serious Adverse Events: From Day 0 to Day 21; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adult Group | Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Induration | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C510903 | fluarix |
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| Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. | Seroprotection rate SPR was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40. The outcome measure was assessed by the influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years. | At Day 0 and Day 21 |
| Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. | SCR was defined as the number of vaccinees with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years. | At Day 21 |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. This outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years. | At Day 21 |
| Duration of Solicited Local Symptoms. | Duration was defined as number of days with any grade of local symptoms. | During the 4-day follow-up period (Days 0-3) after vaccination |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm. | During the 4-day (Day 0-Day 3) follow-up period after vaccination |
| Duration of Solicited General Symptoms. | Duration was defined as number of days with any grade of general symptoms. | During the 4-day follow-up period (Days 0-3) after vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C | During the 4-day follow-up period (Day 0-3) after vaccination |
| Number of Subjects Reporting 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. | During the 21-day follow-up period (Days 0-20) after vaccination |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | During the entire study period (Days 0-21) |
| Dresden |
| Saxony |
| 01099 |
| Germany |
| GSK Investigational Site | Dresden | Saxony | 01129 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01309 | Germany |
Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Fluarix/Influsplit > 60 Years Group | Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. |
|
|
| Primary | Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. | Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Number | Subjects | At Day 0 and Day 21 |
|
|
|
| Primary | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. | A seroconverted subjects was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Number | Subjects | At Day 21 |
|
|
|
| Primary | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 21 |
|
|
|
| Primary | Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value. | SPP was defined as the number of vaccinees with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Number | Subjects | At Day 21 |
|
|
|
| Secondary | Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. | Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included H1N1, H3N2 and Yamagata antigens. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged greater than (>) 60 years. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 0 and Day 21 |
|
|
|
| Secondary | Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. | Seroprotection rate SPR was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40. The outcome measure was assessed by the influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Number | Subjects | At Day 0 and Day 21 |
|
|
|
| Secondary | Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. | SCR was defined as the number of vaccinees with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Number | Subjects | At Day 21 |
|
|
|
| Secondary | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. This outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 21 |
|
|
|
| Secondary | Duration of Solicited Local Symptoms. | Duration was defined as number of days with any grade of local symptoms. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented. | Posted | Median | Full Range | Days | During the 4-day follow-up period (Days 0-3) after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm. | Analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented. | Posted | Number | Subjects | During the 4-day (Day 0-Day 3) follow-up period after vaccination |
|
|
|
| Secondary | Duration of Solicited General Symptoms. | Duration was defined as number of days with any grade of general symptoms. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented. | Posted | Median | Full Range | Days | During the 4-day follow-up period (Days 0-3) after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C | Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented. | Posted | Number | Subjects | During the 4-day follow-up period (Day 0-3) after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented. | Posted | Number | Subjects | During the 21-day follow-up period (Days 0-20) after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented. | Posted | Number | Subjects | During the entire study period (Days 0-21) |
|
|
|
| 0 |
| 60 |
| 39 |
| 60 |
| EG001 | Elderly Group | Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. | 0 | 59 | 35 | 59 |
| Pain | General disorders | Systematic Assessment |
|
| Redness | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Arthralgia | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Gastrointestinal symptoms | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Myalgia | General disorders | Systematic Assessment |
|
| Sweating increase | General disorders | Systematic Assessment |
|
| Injection site pruritus | General disorders | Non-systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| H3N2, Day 0 |
|
| H3N2, Day 21 |
|
| Yamagata, Day 0 |
|
| Yamagata, Day 21 |
|
| Yamagata |
|
| Yamagata |
|
| Yamagata [N=17,7] |
|
| H3N2, Day 0 |
|
| H3N2, Day 21 |
|
| Yamagata, Day 0 |
|
| Yamagata, Day 21 |
|
| H3N2, Day 0 |
|
| H3N2, Day 21 |
|
| Yamagata, Day 0 |
|
| Yamagata, Day 21 |
|
| Yamagata |
|
| Yamagata |
|
| Redness [N=6,7] |
|
| Swelling [N=6,5] |
|
| Any Induration |
|
| Grade 3 Induration |
|
| Any Pain |
|
| Grade 3 Pain |
|
| Any Redness |
|
| Grade 3 Redness |
|
| Any Swelling |
|
| Grade 3 Swelling |
|
| Gastrointestinal symptoms [N=4,3] |
|
| Headache [N=15,7] |
|
| Myalgia [N=11,7] |
|
| Sweating increase [N=8,9] |
|
| Shivering [N=1,2] |
|
| Fever (Axillary) [N=2,1] |
|
| Related Arthralgia |
|
| Any Fatigue |
|
| Grade 3 Fatigue |
|
| Related Fatigue |
|
| Any Gastrointestinal symptoms |
|
| Grade 3 Gastrointestinal symptoms |
|
| Related Gastrointestinal symptoms |
|
| Any Headache |
|
| Grade 3 Headache |
|
| Related Headache |
|
| Any Myalgia |
|
| Grade 3 Myalgia |
|
| Related Myalgia |
|
| Any Shivering |
|
| Grade 3 Shivering |
|
| Related Shivering |
|
| Any Sweating increase |
|
| Grade 3 Sweating increase |
|
| Related Sweating increase |
|
| Any Fever ≥37.5°C |
|
| Grade 3 Fever >39.0°C |
|
| Related Fever |
|
| Related Unsolicted AEs |
|