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This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged 20-64 years.
This Protocol Posting has been updated following Protocol amendment 1& 2, October 2009. The sections impacted are study design and outcome measures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2340274A GROUP | Experimental | Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected 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 |
|---|---|---|---|---|
| Influenza investigational vaccine GSK2340274A | Biological | Two intramuscular injections on Day 0 and Day 21, respectively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | Titers are presented as geometric mean titers (GMTs). | At Day 0 |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | Titers are presented as geometric mean titers (GMTs). | At Day 21 |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | Titers are presented as geometric mean titers (GMTs). | At Day 42 |
| Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen | A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10. | At Day 0 |
| Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10. | At Day 21 |
| Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10. | At Day 42 |
| Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen | A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10. | At Days 0, 21, 42 and 182 |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen |
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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 | Fukuoka | 813-8588 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22426369 | Derived | Ikematsu H, Nagai H, Kawashima M, Kawakami Y, Tenjinbaru K, Li P, Walravens K, Gillard P, Roman F. Characterization and long-term persistence of immune response following two doses of an AS03A-adjuvanted H1N1 influenza vaccine in healthy Japanese adults. Hum Vaccin Immunother. 2012 Feb;8(2):260-6. doi: 10.4161/hv.18469. Epub 2012 Feb 1. | |
| 20980795 |
| 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 |
|---|---|---|---|
| 113519 | Clinical Study Report | 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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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2340274A Group | Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected 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 | GSK2340274A Group | Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| 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 | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | Titers are presented as geometric mean titers (GMTs). | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Geometric Mean | 97.5% Confidence Interval | Titers | At Day 0 |
|
Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).
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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 | GSK2340274A Group | Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected 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 |
|---|---|---|---|---|---|
| Calculus ureteric | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | 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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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller 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 four-fold increase in post-vaccination titer. |
| At Day 21 |
| Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller 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 four-fold increase in post-vaccination titer. | At Day 42 |
| Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. | At Day 0 |
| Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. | At Day 21 |
| Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. | At Day 42 |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. | At Day 21 |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. | At Day 42 |
Titers are presented as geometric mean titers (GMTs). |
| At Days 0, 21, 42 and 182 |
| Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller 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 four-fold increase in post-vaccination titer. | At Days 21, 42 and 182 |
| Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. | At Days 0, 21, 42 and 182 |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. | At Days 21, 42 and 182 |
| Titers for Serum Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen | Titers are presented as geometric mean titers (GMTs). | At Days 0, 21, 42 and 182 |
| Number of Seropositive Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen | A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:8. | At Days 0, 21, 42 and 182 |
| Number of Seroconverted Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen | A seroconverted subject was defined as a vaccinated subject with a minimum 4-fold increase in post vaccination neutralizing titer. | At Days 21, 42 and 182 |
| 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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | During a 7-day (Days 0-6) follow-up after each vaccination |
| 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 temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | During a 7-day (Days 0-6) follow-up after each vaccination |
| 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. | During a 21-day (Days 0-20) follow-up period after the first vaccination and during a 63-day (Days 21-84) follow-up after the second vaccination |
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (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 (Days 0-182) |
| Number of Subjects With Any 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. | During the entire study period (Days 0-182) |
| Number of Days With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. The number of days with any solicited local symptom was assessed in subjects who have reported at least once the symptom. | During a 7-day (Days 0-6) follow-up after each vaccination |
| Number of Days With Any Solicited General Symptoms | Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. The number of days with any solicited general symptom was assessed in subjects who have reported at least once the symptom. | During a 7-day (Days 0-6) follow-up after each vaccination |
| Tokyo |
| 204-8585 |
| Japan |
| Ikematsu H, Nagai H, Kawashima M, Kawakami Y, Tenjinbaru K, Maeda A, Li P, Gillard P, Roman F. Immunogenicity and safety of a novel AS03(A)-adjuvanted H1N1 2009 pandemic influenza vaccine in adults in Japan. Hum Vaccin. 2010 Nov;6(11):888-93. doi: 10.4161/hv.6.11.12851. Epub 2010 Nov 1. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113519 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113519 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113519 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113519 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113519 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113519 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | Titers are presented as geometric mean titers (GMTs). | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Geometric Mean | 97.5% Confidence Interval | Titers | At Day 21 |
|
|
|
| Primary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | Titers are presented as geometric mean titers (GMTs). | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Geometric Mean | 97.5% Confidence Interval | Titers | At Day 42 |
|
|
|
| Primary | Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen | A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Count of Participants | Participants | At Day 0 |
|
|
|
| Primary | Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Count of Participants | Participants | At Day 21 |
|
|
|
| Primary | Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Count of Participants | Participants | At Day 42 |
|
|
|
| Primary | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller 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 four-fold increase in post-vaccination titer. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Count of Participants | Participants | At Day 21 |
|
|
|
| Primary | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller 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 four-fold increase in post-vaccination titer. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Count of Participants | Participants | At Day 42 |
|
|
|
| Primary | Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Count of Participants | Participants | At Day 0 |
|
|
|
| Primary | Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available | Posted | Count of Participants | Participants | At Day 21 |
|
|
|
| Primary | Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Count of Participants | Participants | At Day 42 |
|
|
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| Primary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Geometric Mean | 97.5% Confidence Interval | Fold change | At Day 21 |
|
|
|
| Primary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Geometric Mean | 97.5% Confidence Interval | Fold change | At Day 42 |
|
|
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| Secondary | Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen | A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Count of Participants | Participants | At Days 0, 21, 42 and 182 |
|
|
|
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | Titers are presented as geometric mean titers (GMTs). | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Days 0, 21, 42 and 182 |
|
|
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| Secondary | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller 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 four-fold increase in post-vaccination titer. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Count of Participants | Participants | At Days 21, 42 and 182 |
|
|
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| Secondary | Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Count of Participants | Participants | At Days 0, 21, 42 and 182 |
|
|
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| Secondary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Geometric Mean | 95% Confidence Interval | Fold change | At Days 21, 42 and 182 |
|
|
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| Secondary | Titers for Serum Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen | Titers are presented as geometric mean titers (GMTs). | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Days 0, 21, 42 and 182 |
|
|
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| Secondary | Number of Seropositive Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen | A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:8. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Count of Participants | Participants | At Days 0, 21, 42 and 182 |
|
|
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| Secondary | Number of Seroconverted Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen | A seroconverted subject was defined as a vaccinated subject with a minimum 4-fold increase in post vaccination neutralizing titer. | Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available. | Posted | Count of Participants | Participants | At Days 21, 42 and 182 |
|
|
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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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects. | Posted | Count of Participants | Participants | During a 7-day (Days 0-6) follow-up after each vaccination |
|
|
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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 temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects. | Posted | Count of Participants | Participants | During a 7-day (Days 0-6) follow-up after each vaccination |
|
|
|
| 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. | Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects. | Posted | Count of Participants | Participants | During a 21-day (Days 0-20) follow-up period after the first vaccination and during a 63-day (Days 21-84) follow-up after the second vaccination |
|
|
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the entire study period (Days 0-182) |
|
|
|
| Secondary | Number of Subjects With Any 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. | Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the entire study period (Days 0-182) |
|
|
|
| Secondary | Number of Days With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. The number of days with any solicited local symptom was assessed in subjects who have reported at least once the symptom. | Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects. | Posted | Median | Full Range | Days | During a 7-day (Days 0-6) follow-up after each vaccination |
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|
|
| Secondary | Number of Days With Any Solicited General Symptoms | Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. The number of days with any solicited general symptom was assessed in subjects who have reported at least once the symptom. | Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects. | Posted | Median | Full Range | Days | During a 7-day (Days 0-6) follow-up after each vaccination |
|
|
|
| 0 |
| 100 |
| 2 |
| 100 |
| 100 |
| 100 |
| Pharyngeal ulceration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 13.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Day 42 |
|
| Day 182 |
|
| Day 42 |
|
| Day 182 |
|
| Day 182 |
|
| Day 42 |
|
| Day 182 |
|
| Day 182 |
|
| Day 42 |
|
| Day 182 |
|
| Day 42 |
|
| Day 182 |
|
| Day 182 |
|
| Title | Measurements |
|---|---|
|
| Redness, Grade 3, Dose 1 |
|
| Swelling, Any, Dose 1 |
|
| Swelling, Grade 3, Dose 1 |
|
| Pain, Any, Dose 2 |
|
| Pain, Grade 3, Dose 2 |
|
| Redness, Any, Dose 2 |
|
| Redness, Grade 3, Dose 2 |
|
| Swelling, Any, Dose 2 |
|
| Swelling, Grade 3, Dose 2 |
|
| Pain, Any, Across doses |
|
| Pain, Grade 3, Across doses |
|
| Redness, Any, Across doses |
|
| Redness, Grade 3, Across doses |
|
| Swelling, Any, Across doses |
|
| Swelling, Grade 3, Across doses |
|
| Title | Measurements |
|---|---|
|
| Headache, Any, Dose 1 |
|
| Headache, Grade 3, Dose 1 |
|
| Headache, Related, Dose 1 |
|
| Joint pain at other location, Any, Dose 1 |
|
| Joint pain at other location, Grade 3, Dose 1 |
|
| Joint pain at other location, Related, Dose 1 |
|
| Muscle aches, Any, Dose 1 |
|
| Muscle aches, Grade 3, Dose 1 |
|
| Muscle aches, Related, Dose 1 |
|
| Shivering, Any, Dose 1 |
|
| Shivering, Grade 3, Dose 1 |
|
| Shivering, Related, Dose 1 |
|
| Sweating, Any, Dose 1 |
|
| Sweating, Grade 3, Dose 1 |
|
| Sweating, Related, Dose 1 |
|
| Temperature (Axillary), Any, Dose 1 |
|
| Temperature (Axillary), Grade 3, Dose 1 |
|
| Temperature (Axillary), Related, Dose 1 |
|
| Fatigue, Any, Dose 2 |
|
| Fatigue, Grade 3, Dose 2 |
|
| Fatigue, Related, Dose 2 |
|
| Headache, Any, Dose 2 |
|
| Headache, Grade 3, Dose 2 |
|
| Headache, Related, Dose 2 |
|
| Joint pain at other location, Any, Dose 2 |
|
| Joint pain at other location, Grade 3, Dose 2 |
|
| Joint pain at other location, Related, Dose 2 |
|
| Muscle aches, Any, Dose 2 |
|
| Muscle aches, Grade 3, Dose 2 |
|
| Muscle aches, Related, Dose 2 |
|
| Shivering, Any, Dose 2 |
|
| Shivering, Grade 3, Dose 2 |
|
| Shivering, Related, Dose 2 |
|
| Sweating, Any, Dose 2 |
|
| Sweating, Grade 3, Dose 2 |
|
| Sweating, Related, Dose 2 |
|
| Temperature (Axillary), Any, Dose 2 |
|
| Temperature (Axillary), Grade 3, Dose 2 |
|
| Temperature (Axillary), Related, Dose 2 |
|
| Fatigue, Any, Across doses |
|
| Fatigue, Grade 3, Across doses |
|
| Fatigue, Related, Across doses |
|
| Headache, Any, Across doses |
|
| Headache, Grade 3, Across doses |
|
| Headache, Related, Across doses |
|
| Joint pain at other location, Any, Across doses |
|
| Joint pain at other location, Grade 3, Across dose |
|
| Joint pain at other location, Related, Across dose |
|
| Muscle aches, Any, Across doses |
|
| Muscle aches, Grade 3, Across doses |
|
| Muscle aches, Related, Across doses |
|
| Shivering, Any, Across doses |
|
| Shivering, Grade 3, Across doses |
|
| Shivering, Related, Across doses |
|
| Sweating, Any, Across doses |
|
| Sweating, Grade 3, Across doses |
|
| Sweating, Related, Across doses |
|
| Temperature (Axillary), Any, Across doses |
|
| Temperature (Axillary), Grade 3, Across doses |
|
| Temperature (Axillary), Related, Across doses |
|
| Title | Measurements |
|---|---|
|
|
| Swelling, Dose 1 |
|
|
| Pain, Dose 2 |
|
|
| Redness, Dose 2 |
|
|
| Swelling, Dose 2 |
|
|
|
| Joint pain at other location, Dose 1 |
|
|
| Muscle aches, Dose 1 |
|
|
| Sweating, Dose 1 |
|
|
| Shivering, Dose 1 |
|
|
| Temperature, Dose 1 |
|
|
| Fatigue, Dose 2 |
|
|
| Headache, Dose 2 |
|
|
| Joint pain at other location, Dose 2 |
|
|
| Muscle aches, Dose 2 |
|
|
| Sweating, Dose 2 |
|
|
| Shivering, Dose 2 |
|
|
| Temperature, Dose 2 |
|
|