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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001118-24 | EudraCT Number |
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The purpose of this study is to investigate the immunogenicity and safety when GSK Biologicals' influenza vaccine Influsplit™ Tetra (Fluarix™ Tetra) is co-administered with Merck & Co. Inc.'s pneumococcal vaccine (Pneumovax™23/Pneumovax) in adults 50 years of age and older at risk for complications from influenza and pneumococcal infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Co-Ad Group | Experimental | Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28. |
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| Control Group | Experimental | Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influsplit™ Tetra (Fluarix™ Tetra) | Biological | Intramuscular injection, 1 dose each in Control and Co-Ad groups. |
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| Measure | Description | Time Frame |
|---|---|---|
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains. | HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata). | At Day 28 post Influsplit™ Tetra vaccination |
| Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group). | At 28 days after Pneumovax™ 23 vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. > 100mm. | Within 7 days (Days 0 - 6) after each dose and across doses. |
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Inclusion Criteria:
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
A male or female aged 50 years or above at the time of the first vaccination at risk for complications from influenza and/or pneumococcal infections, meeting their respective countries' recommendations for vaccination against influenza and pneumococcal disease.
Written informed consent obtained from the subject.
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:
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled, topical and low-dose intra-articular steroids are allowed.
Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose and 30 days after the last dose of vaccine.
Administration of such a vaccine has to be documented in the "Concomitant vaccination" of the electronic Case Report Form (eCRF).
Administration of long-acting immune-modifying drugs/treatment within six months prior to the first vaccine dose or expected administration at any time during the study period. These immunosuppressant drugs/treatment/Biologics include:
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Previous vaccination with a pneumococcal vaccine within the last five years.
Previous vaccination with an influenza vaccine within the last six months.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. HIV infected subjects on cART with CD4 T-cell counts above 350 cells/mm3 can be enrolled.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Acute disease and/or fever at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study or would make intramuscular (IM) injection unsafe.
Asplenia or dysfunction of the spleen. This excludes homozygous sickle cell disease or coeliac syndrome that may lead to splenic dysfunction.
Acute clinically significant (i.e. a medically significant change from baseline condition in the past 30 days) pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
History of chronic alcohol consumption and/or drug abuse.
History of Guillain-Barré syndrome.
A history of anaphylaxis following ANY vaccination.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ghent | 9000 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28987445 | Derived | Ofori-Anyinam O, Leroux-Roels G, Drame M, Aerssens A, Maes C, Amanullah A, Schuind A, Li P, Jain VK, Innis BL. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine co-administered with a 23-valent pneumococcal polysaccharide vaccine versus separate administration, in adults >/=50years of age: Results from a phase III, randomized, non-inferiority trial. Vaccine. 2017 Nov 1;35(46):6321-6328. doi: 10.1016/j.vaccine.2017.09.012. Epub 2017 Oct 5. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 117276 | Dataset Specification | View IPD |
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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Of the 357 subjects enrolled, 1 subject failed to meet the inclusion criteria hence he/she was excluded from study start.
In the Control Group, 2 subjects withdrew at Day 0. In the Co-Ad Group, 4 subjects withdrew at Day 0, 1 subject withdrew at Day 28 and 1 subject withdrew at Day 56.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28. |
| FG001 | Co-Ad Group | Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Pneumovax™ 23 | Biological | Intramuscular injection, 1 dose each in Control and Co-Ad groups. |
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| Placebo (Saline) | Biological | Intramuscular injection, 1 dose each in Control and Co-Ad groups. |
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| Number of Subjects Reporting Solicited General Adverse Events (AEs) | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms*, headache, joint pain, muscle aches, shivering, sweating and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal everyday activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as temperature greater than (>)39.0°C. *Gastrointestinal (GI) symptoms included nausea, vomiting, diarrhoea and/or abdominal pain | Within 7 days (Days 0 - 6) after each dose and across doses. |
| Duration of Local Adverse Events | Duration was defined as number of days with any grade of local symptoms. | During the 7-day (Days 0-6) post-vaccination period |
| Duration of Solicited General AEs. | Duration was defined as number of days with any grade of general symptoms. | During the 7-day (Days 0-6) post-vaccination period |
| Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs) | MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s) regardless of intensity grade or relationship to vaccination. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination. | Throughout the study period (Days 0-180) |
| Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs) | Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any was defined as any occurrence of pIMD(s) regardless of intensity grade or relationship to vaccination. Related was defined as pIMD assessed by the investigator to be causally related to the study vaccination. | During the entire study period (Days 0-180) |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | Within the 28-day (Days 0-27) post-vaccination period |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. 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. | Throughout the study period (Days 0-180) |
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata). | At Day 0 and Day 28 |
| Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata). | At Day 0 and Day 28 |
| Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata). | At Day 28 |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. | MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata). | At Day 28 |
| Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | The pneumococcal antigen testing was performed, as determined by ELISA cut-offs of ≥0.05 µg/mL and a seroprotection cut-off of ≥ 0.2 µg/ml. PRE = Pre-vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group. POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group. | At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only) |
| Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) PRE = Pre -vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group. POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group. | At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only) |
| Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Fold antibody concentration increases post-vaccination/pre-vaccination ≥ 2 and ≥ 4. The anti-pneumococcal serotypes assessed were 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. | At 28 days post-vaccination with Pneumovax™ 23 |
| Angers |
| 49000 |
| France |
| GSK Investigational Site | Laval | 53000 | France |
| GSK Investigational Site | Nantes | 44277 | France |
| GSK Investigational Site | Saint-Cyr-sur-Loire | 37540 | France |
| GSK Investigational Site | Tours | 37100 | France |
For additional information about this study please refer to the GSK Clinical Study Register |
| 117276 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117276 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117276 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117276 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117276 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117276 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28. |
| BG001 | Co-Ad Group | Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| 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 Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains. | HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata). | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 28 post Influsplit™ Tetra vaccination |
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| Primary | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group). | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Posted | Geometric Mean | 95% Confidence Interval | ug per ml | At 28 days after Pneumovax™ 23 vaccination |
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| Secondary | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. > 100mm. | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | Number | Subjects | Within 7 days (Days 0 - 6) after each dose and across doses. |
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| Secondary | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms*, headache, joint pain, muscle aches, shivering, sweating and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal everyday activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as temperature greater than (>)39.0°C. *Gastrointestinal (GI) symptoms included nausea, vomiting, diarrhoea and/or abdominal pain | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | Number | Subjects | Within 7 days (Days 0 - 6) after each dose and across doses. |
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| Secondary | Duration of Local Adverse Events | Duration was defined as number of days with any grade of local symptoms. | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | Median | Full Range | Days | During the 7-day (Days 0-6) post-vaccination period |
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| Secondary | Duration of Solicited General AEs. | Duration was defined as number of days with any grade of general symptoms. | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | Median | Full Range | Days | During the 7-day (Days 0-6) post-vaccination period |
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| Secondary | Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs) | MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s) regardless of intensity grade or relationship to vaccination. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | Number | Subjects | Throughout the study period (Days 0-180) |
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| Secondary | Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs) | Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any was defined as any occurrence of pIMD(s) regardless of intensity grade or relationship to vaccination. Related was defined as pIMD assessed by the investigator to be causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | Number | Subjects | During the entire study period (Days 0-180) |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | Number | Subjects | Within the 28-day (Days 0-27) post-vaccination period |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. 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. | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | Number | Subjects | Throughout the study period (Days 0-180) |
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| Secondary | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata). | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 0 and Day 28 |
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| Secondary | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata). | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Posted | Number | Subjects | At Day 0 and Day 28 |
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| Secondary | Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata). | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Posted | Number | Subjects | At Day 28 |
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| Secondary | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. | MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata). | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 28 |
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| Secondary | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | The pneumococcal antigen testing was performed, as determined by ELISA cut-offs of ≥0.05 µg/mL and a seroprotection cut-off of ≥ 0.2 µg/ml. PRE = Pre-vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group. POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Posted | Number | Subjects | At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only) |
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| Secondary | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) PRE = Pre -vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group. POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only) |
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| Secondary | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Fold antibody concentration increases post-vaccination/pre-vaccination ≥ 2 and ≥ 4. The anti-pneumococcal serotypes assessed were 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Posted | Number | Subjects | At 28 days post-vaccination with Pneumovax™ 23 |
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Serious Adverse Events: During the entire study period (Day 0 to 180); Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28. | 11 | 179 | 117 | 179 | ||
| EG001 | Co-Ad Group | Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28. | 7 | 177 | 127 | 177 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Intestinal malrotation | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Intestinal ischaemia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Calcinosis | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Erysipelas | Infections and infestations | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Wrist fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Renal cancer stage ii | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Squamous cell carcinoma of the oral cavity | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Carotid artery stenosis | Nervous system disorders | Systematic Assessment |
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| Cerebral thrombosis | Nervous system disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
| ||
| Gastrointestinal disorder | Gastrointestinal disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Swelling | General disorders | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| Male |
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| White - Arabic / North African Heritage |
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| White - Caucasian / European Heritage |
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| Mixed Origin |
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| Victoria |
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| Yamagata |
|
Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0. |
| The adjusted GMT of HI antibodies for H3N2 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate. | ANCOVA | Adjusted GMT ratio | 0.97 | 2-Sided | 95 | 0.78 | 1.21 | The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval. | Non-Inferiority or Equivalence | Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0. |
| The adjusted GMT of HI antibodies for Victoria strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate. | ANCOVA | Adjusted GMT ratio | 1.17 | 2-Sided | 95 | 0.98 | 1.40 | The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval. | Non-Inferiority or Equivalence | Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0. |
| The adjusted GMT of HI antibodies for Yamagata strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate. | ANCOVA | Adjusted GMT ratio | 0.99 | 2-Sided | 95 | 0.84 | 1.16 | The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval. | Non-Inferiority or Equivalence | Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0. |
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