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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016078-33 | EudraCT Number |
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The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in adults aged 18 to 60 years.
This Protocol Posting has been updated following Protocol amendment 1, October 2009. The impacted section is the outcomes measures section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2340272A Group | Experimental | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
|
| GSK2340269A Group | Experimental | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2340272A | Biological | Two intramuscular injections in the deltoid region of the non-dominant arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain | Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). | At Day 21 |
| Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 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. | At Day 21 |
| Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. | At Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Were Seropositive for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection. | At Days 0, 21 and 42 |
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Inclusion Criteria:
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 | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21450978 | Background | Roman F, Clement F, Dewe W, Walravens K, Maes C, Willekens J, De Boever F, Hanon E, Leroux-Roels G. Effect on cellular and humoral immune responses of the AS03 adjuvant system in an A/H1N1/2009 influenza virus vaccine administered to adults during two randomized controlled trials. Clin Vaccine Immunol. 2011 May;18(5):835-43. doi: 10.1128/CVI.00480-10. Epub 2011 Mar 30. | |
| 28446441 |
| 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 |
|---|---|---|---|
| 113866 | Informed Consent Form | View IPD |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2340272A Group | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| FG001 | GSK2340269A Group | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK2340272A Group | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| BG001 | GSK2340269A 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 | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain | Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose. | Posted | Count of Participants | Participants | At Day 21 |
|
Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
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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 | GSK2340272A Group | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | 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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| GSK2340269A | Biological | Two intramuscular injections in the deltoid region of the non-dominant arm. |
|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease |
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. |
| At Days 0, 21 and 42 |
| Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain | A seropositive subject was defined as a vaccinated subject with a serum HI titer ≥ 1:10, that usually is accepted as indicating protection. | At Days 0, 21 and 42 |
| Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. | At Days 0, 21 and 42 |
| Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection. | At Days 182 and 364 |
| Titers for Serum HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10. | At Days 182 and 364 |
| Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain | A seropositive subject was defined as a vaccinated subject with a serum HI titer ≥ 1:10, that usually is accepted as indicating protection. | At Days 182 and 364 |
| Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. | At Days 182 and 364 |
| Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). | At Days 21 and 42 |
| Number of Seroconverted (SCR) Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). | At Days 182 and 364 |
| Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | Seroconversion was defined as: For initially seronegative subjects (antibody titer < 10 post-vaccination), antibody titer ≥ 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). | At Days 182 and 364 |
| Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 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. | At Days 0, 21 and 42 |
| Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. | At Days 182 and 364 |
| Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. | At Days 21 and 42 |
| Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. | At Days 182 and 364 |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27) |
| Number of Days With Solicited Local Symptoms | The number of days with any solicited local symptoms reported during the solicited post-vaccination period. No subjects in GSK2340269A Group reported redness or swelling. | During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27) |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or their relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27) |
| Number of Days With Solicited General Symptoms | The number of days with any solicited general symptoms reported during the solicited post-vaccination period. No subjects from the GSK2340269A Group reported any temperature after Dose 2. | During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27) |
| Number of Subjects With Adverse Events of Specific Interest (AESIs) | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. | From Day 0 up to Day 364 |
| Number of Subjects With Any, Grade 3 and Related 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 84) |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period (from Day 0 up to Day 364) |
| Derived |
| van der Most RG, Clement F, Willekens J, Dewe W, Walravens K, Vaughn DW, Leroux-Roels G. Long-Term Persistence of Cell-Mediated and Humoral Responses to A(H1N1)pdm09 Influenza Virus Vaccines and the Role of the AS03 Adjuvant System in Adults during Two Randomized Controlled Trials. Clin Vaccine Immunol. 2017 Jun 5;24(6):e00553-16. doi: 10.1128/CVI.00553-16. Print 2017 Jun. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113866 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113866 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113866 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113866 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113866 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113866 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| OG001 | GSK2340269A Group | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
|
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| Primary | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 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. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose. | Posted | Count of Participants | Participants | At Day 21 |
|
|
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| Primary | Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose. | Posted | Geometric Mean | 95% Confidence Interval | Fold change | At Day 21 |
|
|
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| Secondary | Number of Subjects Who Were Seropositive for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose. | Posted | Count of Participants | Participants | At Days 0, 21 and 42 |
|
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| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Days 0, 21 and 42 |
|
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| Secondary | Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain | A seropositive subject was defined as a vaccinated subject with a serum HI titer ≥ 1:10, that usually is accepted as indicating protection. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose. | Posted | Count of Participants | Participants | At Days 0, 21 and 42 |
|
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| Secondary | Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Days 0, 21 and 42 |
|
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| Secondary | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection. | The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | At Days 182 and 364 |
|
|
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| Secondary | Titers for Serum HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10. | The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Days 182 and 364 |
|
|
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| Secondary | Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain | A seropositive subject was defined as a vaccinated subject with a serum HI titer ≥ 1:10, that usually is accepted as indicating protection. | The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | At Days 182 and 364 |
|
|
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| Secondary | Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. | The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Days 182 and 364 |
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| Secondary | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose. | Posted | Count of Participants | Participants | At Days 21 and 42 |
|
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| Secondary | Number of Seroconverted (SCR) Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). | The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | At Days 182 and 364 |
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| Secondary | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | Seroconversion was defined as: For initially seronegative subjects (antibody titer < 10 post-vaccination), antibody titer ≥ 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). | The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | At Days 182 and 364 |
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| Secondary | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 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. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose. | Posted | Count of Participants | Participants | At Days 0, 21 and 42 |
|
|
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| Secondary | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. | The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | At Days 182 and 364 |
|
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| Secondary | Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose. | Posted | Geometric Mean | 95% Confidence Interval | Fold change | At Days 21 and 42 |
|
|
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| Secondary | Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease | GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. | The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Fold change | At Days 182 and 364 |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets. | Posted | Count of Participants | Participants | During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27) |
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| Secondary | Number of Days With Solicited Local Symptoms | The number of days with any solicited local symptoms reported during the solicited post-vaccination period. No subjects in GSK2340269A Group reported redness or swelling. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets. | Posted | Median | Inter-Quartile Range | Days | During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27) | Doses with the symptom | Doses with the symptom |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or their relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets. | Posted | Count of Participants | Participants | During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27) |
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| Secondary | Number of Days With Solicited General Symptoms | The number of days with any solicited general symptoms reported during the solicited post-vaccination period. No subjects from the GSK2340269A Group reported any temperature after Dose 2. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Median | Inter-Quartile Range | Days | During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27) | Doses with the symptom | Doses with the symptom |
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| Secondary | Number of Subjects With Adverse Events of Specific Interest (AESIs) | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | From Day 0 up to Day 364 |
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| Secondary | Number of Subjects With Any, Grade 3 and Related 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 84) |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 up to Day 364) |
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|
| 0 |
| 65 |
| 4 |
| 65 |
| 63 |
| 65 |
| EG001 | GSK2340269A Group | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | 0 | 66 | 4 | 66 | 51 | 66 |
| Abortion spontaneous complete | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 | Systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
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| Calculus ureteric | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Renal disorder | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Open wound | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Redness | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Joint Pain ar other location | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Muscle aches | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Shivering | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Sweating | General disorders | MedDRA 13.1 | 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.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Flu A/CAL/7/09, Day 42 |
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| Flu A/CAL/7/09, Day 42 |
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| Flu A/CAL/7/09, Day 21 |
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| Flu A/CAL/7/09, Day 42 |
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| Flu A/CAL/7/09, Day 21 |
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| Flu A/CAL/7/09, Day 42 |
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| Flu A/CAL/7/09, Day 364 |
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| Flu A/CAL/7/09, Day 364 |
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| Flu A/CAL/7/09, Day 364 |
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| Flu A/CAL/7/09, Day 364 |
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| Flu A/CAL/7/09, Day 42 |
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| Flu A/CAL/7/09, Day 364 |
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| Flu A/CAL/7/09, Day 364 |
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| Flu A/CAL/7/09, Day 21 |
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| Flu A/CAL/7/09, Day 42 |
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| Flu A/CAL/7/09, Day 364 |
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| Flu A/CAL/7/09, Day 42 |
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| Flu A/CAL/7/09, Day 364 |
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| Grade 3 Pain, Dose 1 |
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| Any Redness, Dose 1 |
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| Grade 3 Redness, Dose 1 |
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| Any Swelling, Dose 1 |
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| Grade 3 Swelling, Dose 1 |
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| Any Pain, Dose 2 |
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| Grade 3 Pain, Dose 2 |
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| Any Redness, Dose 2 |
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| Grade 3 Redness, Dose 2 |
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| Any Swelling, Dose 2 |
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| Grade 3 Swelling, Dose 2 |
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| Any Pain, Across doses |
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| Grade 3 Pain, Across doses |
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| Any Redness, Across doses |
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| Grade 3 Redness, Across doses |
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| Any Swelling, Across doses |
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| Grade 3 Swelling, Across doses |
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| Pain, Dose 2 |
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| Pain, Overall/dose |
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| Redness, Dose 1 |
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| Redness, Dose 2 |
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| Redness, Overall/dose |
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| Swelling, Dose 1 |
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| Swelling, Dose 2 |
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| Swelling, Overall/dose |
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| Grade 3 Fatigue, Dose 1 |
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| Related Fatigue, Dose 1 |
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| Any Headache, Dose 1 |
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| Grade 3 Headache, Dose 1 |
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| Related Headache, Dose 1 |
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| Any Joint pain, Dose 1 |
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| Grade 3 Joint pain, Dose 1 |
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| Related Joint pain, Dose 1 |
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| Any Muscle aches, Dose 1 |
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| Grade 3 Muscle aches, Dose 1 |
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| Related Muscle aches, Dose 1 |
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| Any Shivering, Dose 1 |
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| Grade 3 Shivering, Dose 1 |
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| Related Shivering, Dose 1 |
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| Any Sweating, Dose 1 |
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| Grade 3 Sweating, Dose 1 |
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| Related Sweating, Dose 1 |
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| Any Temperature, Dose 1 |
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| Grade 3 Temperature, Dose 1 |
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| Related Temperature, Dose 1 |
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| Any Fatigue, Dose 2 |
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| Grade 3 Fatigue, Dose 2 |
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| Related Fatigue, Dose 2 |
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| Any Headache, Dose 2 |
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| Grade 3 Headache, Dose 2 |
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| Related Headache, Dose 2 |
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| Any Joint pain, Dose 2 |
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| Grade 3 Joint pain, Dose 2 |
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| Related Joint pain, Dose 2 |
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| Any Muscle aches, Dose 2 |
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| Grade 3 Muscle aches, Dose 2 |
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| Related Muscle aches, Dose 2 |
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| Any Shivering, Dose 2 |
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| Grade 3 Shivering, Dose 2 |
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| Related Shivering, Dose 2 |
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| Any Sweating, Dose 2 |
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| Grade 3 Sweating, Dose 2 |
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| Related Sweating, Dose 2 |
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| Any Temperature, Dose 2 |
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| Grade 3 Temperature, Dose 2 |
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| Related Temperature, Dose 2 |
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| Any Fatigue, Across doses |
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| Grade 3 Fatigue, Across doses |
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| Related Fatigue, Across doses |
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| Any Headache, Across doses |
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| Grade 3 Headache, Across doses |
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| Related Headache, Across doses |
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| Any Joint pain, Across doses |
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| Grade 3 Joint pain, Across doses |
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| Related Joint pain, Across doses |
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| Any Muscle aches, Across doses |
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| Grade 3 Muscle aches, Across doses |
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| Related Muscle aches, Across doses |
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| Any Shivering, Across doses |
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| Grade 3 Shivering, Across doses |
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| Related Shivering, Across doses |
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| Any Sweating, Across doses |
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| Grade 3 Sweating, Across doses |
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| Related Sweating, Across doses |
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| Any Temperature, Across doses |
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| Grade 3 Temperature, Across doses |
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| Related Temperature, Across doses |
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| Fatigue, Dose 2 |
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| Fatigue, Overall/dose |
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| Headache, Dose 1 |
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| Headache, Dose 2 |
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| Headache, Overall/dose |
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| Joint pain, Dose 1 |
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| Joint pain, Dose 2 |
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| Joint pain, Overall/dose |
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| Muscle aches, Dose 1 |
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| Muscle aches, Dose 2 |
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| Muscle aches, Overall/dose |
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| Sweating, Dose 1 |
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| Sweating, Dose 2 |
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| Sweating, Overall/dose |
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| Shivering, Dose 1 |
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| Shivering, Dose 2 |
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| Shivering, Overall/dose |
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| Temperature, Dose 1 |
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| Temperature, Dose 2 |
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| Temperature, Overall/dose |
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| Related AE(s), Days 0-20 |
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| Any AE(s), up to Day 84 |
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| Grade 3 AE(s), up to Day 84 |
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| Related AE(s), up to Day 84 |
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