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This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza A (H5N1) 20-40 Years Group | Experimental | Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Influenza A (H5N1) 41-64 Years Group | Experimental | Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted | Biological | All subjects will receive 2 doses administered as an intramuscular (IM) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia). | At Day 0 and Day 42 |
| Number of Subjects Seroconverted for H5N1 HI Antibodies | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The H5N1 vaccine strain included A/Indonesia antigen. | At Day 42 |
| HI Antibody Seroconversion Factors for H5N1 HI Antibodies | Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen. | At Day 0 and Day 42 |
| Number of Subjects Seroprotected for H5N1 HI Antibodies | A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen. | At Day 42 |
| Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen. | At Day 0, Day 21 and Day 182 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seroconverted for H5N1 HI Antibodies | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia 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 |
|---|---|---|---|
| 21108818 | Derived | Nagai H, Ikematsu H, Tenjinbaru K, Maeda A, Drame M, Roman FP. A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1) influenza vaccine in healthy Japanese adults. BMC Infect Dis. 2010 Nov 25;10:338. doi: 10.1186/1471-2334-10-338. |
| 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 |
|---|---|---|---|
| 111756 | Study Protocol | 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 | Influenza A (H5N1) 20-40 Years Group | Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. |
| FG001 | Influenza A (H5N1) 41-64 Years Group | Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Influenza A (H5N1) 20-40 Years Group | Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG001 | Influenza A (H5N1) 41-64 Years Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia). | Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 0 and Day 42 |
|
Serious Adverse Events = From Days 0-181. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
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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 | Influenza A (H5N1) 20-40 Years Group | Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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|
| At Day 21 and Day 182 |
| Seroconversion Factors for H5N1 HI Antibodies | Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen. | At Day 21 and Day 182 |
| Number of Subjects Seroprotected for H5N1 HI Antibodies | A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen. | At Day 0, Day 21 and Day 182 |
| Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies | Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen. | At Day 0, Day 42 and Day 182 |
| Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies | A seroconverted subject was defined as a subject with a minimum 4 fold increase in titer at post-vaccination for neutralising antibody response at Days 42 and 182. The H5N1 vaccine strain included A/Indonesia antigen. | At Day 42 and Day 182 |
| Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | Biochemical and haematological parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS) and blood urea nitrogen (BUN ). Categories = unknown, below, within, or above the normal ranges. | At Day 0, Day 7 and Day 42 |
| Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | Biochemical and haematological parameters assessed in blood samples include creatinine (CREA), eosinophils (EOS), hemoglobin (HB) and hematocrit (HC). Categories = unknown, below, within, or above the normal ranges. | At Day 0, Day 7 and Day 42 |
| Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU). Categories = unknown, below, within, or above the normal ranges. | At Day 0, Day 7 and Day 42 |
| Number of Subjects With Any Normal or Abnormal Urine Values | Urine parameters assessed were blood, glucose, protein and urobilinogen. Categories = negative, positive | At Day 0, Day 7 and Day 42 |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling/induration. Any=any solicited local symptom reported regardless of their intensity. Grade 3 pain= significant pain at rest that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling/induration=redness and swelling/induration above 100 millimetres (mm). | During the 7-day post vaccination period (Days 0-6) after any vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increase sweating and fever. Any=any solicited general symptom reported regardless of their intensity grade or their relationship to vaccination. Any fever was ≥ 38.0 degrees celsius (°C). Grade 3 = 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 was≥ 39.0°C. Related= general symptom assessed by the investigator as causally related to the study vaccination. | During the 7-day post vaccination period (Days 0-6) after any vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. | During the 21-day (Days 0-20) following vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. | From Day 0 to Day 83 following vaccination |
| Number of Subjects Reporting Any Medically-significant Conditions (MSCs) | MSCs were defined as AEs with a medically-attended visit (s) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. | During the 182-day (Days 0-181) 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. | During the entire study period (Day 0 to Day 181) |
| Tokyo |
| 204-8585 |
| Japan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111756 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111756 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111756 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111756 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111756 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111756 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Influenza A (H5N1) 41-64 Years Group | Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. |
|
|
| Primary | Number of Subjects Seroconverted for H5N1 HI Antibodies | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The H5N1 vaccine strain included A/Indonesia antigen. | Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 42 |
|
|
|
| Primary | HI Antibody Seroconversion Factors for H5N1 HI Antibodies | Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen. | Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Fold Increase | At Day 0 and Day 42 |
|
|
|
| Primary | Number of Subjects Seroprotected for H5N1 HI Antibodies | A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen. | Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 42 |
|
|
|
| Primary | Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain | Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen. | Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 0, Day 21 and Day 182 |
|
|
|
| Secondary | Number of Subjects Seroconverted for H5N1 HI Antibodies | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen. | Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182. | Posted | Count of Participants | Participants | At Day 21 and Day 182 |
|
|
|
| Secondary | Seroconversion Factors for H5N1 HI Antibodies | Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen. | Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182. | Posted | Geometric Mean | 95% Confidence Interval | Fold Increase | At Day 21 and Day 182 |
|
|
|
| Secondary | Number of Subjects Seroprotected for H5N1 HI Antibodies | A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen. | Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182. | Posted | Count of Participants | Participants | At Day 0, Day 21 and Day 182 |
|
|
|
| Secondary | Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies | Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen. | Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 0, Day 42 and Day 182 |
|
|
|
| Secondary | Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies | A seroconverted subject was defined as a subject with a minimum 4 fold increase in titer at post-vaccination for neutralising antibody response at Days 42 and 182. The H5N1 vaccine strain included A/Indonesia antigen. | Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182. | Posted | Count of Participants | Participants | At Day 42 and Day 182 |
|
|
|
| Secondary | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | Biochemical and haematological parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS) and blood urea nitrogen (BUN ). Categories = unknown, below, within, or above the normal ranges. | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | At Day 0, Day 7 and Day 42 |
|
|
|
| Secondary | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | Biochemical and haematological parameters assessed in blood samples include creatinine (CREA), eosinophils (EOS), hemoglobin (HB) and hematocrit (HC). Categories = unknown, below, within, or above the normal ranges. | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | At Day 0, Day 7 and Day 42 |
|
|
|
| Secondary | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU). Categories = unknown, below, within, or above the normal ranges. | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | At Day 0, Day 7 and Day 42 |
|
|
|
| Secondary | Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities | Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU). Categories = unknown, below, within, or above the normal ranges. | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | At Day 0, Day 7 and Day 42 |
|
|
|
| Secondary | Number of Subjects With Any Normal or Abnormal Urine Values | Urine parameters assessed were blood, glucose, protein and urobilinogen. Categories = negative, positive | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | At Day 0, Day 7 and Day 42 |
|
|
|
| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling/induration. Any=any solicited local symptom reported regardless of their intensity. Grade 3 pain= significant pain at rest that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling/induration=redness and swelling/induration above 100 millimetres (mm). | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 7-day post vaccination period (Days 0-6) after any vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increase sweating and fever. Any=any solicited general symptom reported regardless of their intensity grade or their relationship to vaccination. Any fever was ≥ 38.0 degrees celsius (°C). Grade 3 = 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 was≥ 39.0°C. Related= general symptom assessed by the investigator as causally related to the study vaccination. | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 7-day post vaccination period (Days 0-6) after any vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 21-day (Days 0-20) following vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | From Day 0 to Day 83 following vaccination |
|
|
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| Secondary | Number of Subjects Reporting Any Medically-significant Conditions (MSCs) | MSCs were defined as AEs with a medically-attended visit (s) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 182-day (Days 0-181) 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. | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the entire study period (Day 0 to Day 181) |
|
|
|
| 0 |
| 50 |
| 50 |
| 50 |
| EG001 | Influenza A (H5N1) 41-64 Years Group | Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. | 0 | 50 | 50 | 50 |
| Redness | General disorders | Systematic Assessment |
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| Swelling/ Induration | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
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| Joint pain | General disorders | Systematic Assessment |
|
| Muscle aches | General disorders | Systematic Assessment |
|
| Shivering | General disorders | Systematic Assessment |
|
| Increase Sweating | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Injection site pruritus | General disorders | Non-systematic Assessment | Assessed during Days 0-20 post vaccination period |
|
| Injection site warmth | General disorders | Non-systematic Assessment | Assessed during Days 0-20 post vaccination period |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment | Assessed during Days 0-20 post vaccination period |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment | Assessed during Days 0-20 post vaccination period |
|
| Injection site pruritus | General disorders | Non-systematic Assessment | Assessed during Days 0-83 post vaccination period |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment | Assessed during Days 0-83 post vaccination period |
|
| Injection site warmth | General disorders | Non-systematic Assessment | Assessed during Days 0-83 post vaccination period |
|
| Headache | Nervous system disorders | Non-systematic Assessment | Assessed during Days 0-83 post vaccination period |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment | Assessed during Days 0-83 post vaccination period |
|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment | Assessed during Days 0-83 post vaccination period |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment | Assessed during Days 0-83 post vaccination period |
|
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 |
| A/Indonesia at Day 21 |
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| A/Indonesia at Day 182 |
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| A/Indonesia at Day 182 |
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| A/Indonesia at Day 182 |
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| A/Indonesia at Day 21 |
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| A/Indonesia at Day 182 |
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| A/Indonesia at Day 42 |
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| A/Indonesia at Day 182 |
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| A/Indonesia at Day 182 |
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| ALT [Unknown] at Day 42 |
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| ALT [Below] at Day 0 |
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| ALT [Below] at Day 7 |
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| ALT [Below] at Day 42 |
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| ALT [Within] at Day 0 |
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| ALT [Within] at Day 7 |
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| ALT [Within] at Day 42 |
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| ALT [Above] at Day 0 |
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| ALT [Above] at Day 7 |
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| ALT [Above] at Day 42 |
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| AST [Unknown] at Day 0 |
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| AST [Unknown] at Day 7 |
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| AST [Unknown] at Day 42 |
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| AST [Below] at Day 0 |
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| AST [Below] at Day 7 |
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| AST [Below] at Day 42 |
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| AST [Within] at Day 0 |
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| AST [Within] at Day 7 |
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| AST [Within] at Day 42 |
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| AST [Above] at Day 0 |
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| AST [Above] at Day 7 |
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| AST [Above] at Day 42 |
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| BAS [Unknown] at Day 0 |
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| BAS [Unknown] at Day 7 |
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| BAS [Unknown] at Day 42 |
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| BAS [Below] at Day 0 |
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| BAS [Below] at Day 7 |
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| BAS [Below] at Day 42 |
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| BAS [Within] at Day 0 |
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| BAS [Within] at Day 7 |
|
| BAS [Within] at Day 42 |
|
| BAS [Above] at Day 0 |
|
| BAS [Above] at Day 7 |
|
| BAS [Above] at Day 42 |
|
| BUN [Unknown] at Day 0 |
|
| BUN [Unknown] at Day 7 |
|
| BUN [Unknown] at Day 42 |
|
| BUN [Below] at Day 0 |
|
| BUN [Below] at Day 7 |
|
| BUN [Below] at Day 42 |
|
| BUN [Within] at Day 0 |
|
| BUN [Within] at Day 7 |
|
| BUN [Within] at Day 42 |
|
| BUN [Above] at Day 0 |
|
| BUN [Above] at Day 7 |
|
| BUN [Above] at Day 42 |
|
| CREA [Unknown] at Day 42 |
|
| CREA [Below] at Day 0 |
|
| CREA [Below] at Day 7 |
|
| CREA [Below] at Day 42 |
|
| CREA [Within] at Day 0 |
|
| CREA [Within] at Day 7 |
|
| CREA [Within] at Day 42 |
|
| CREA [Above] at Day 0 |
|
| CREA [Above] at Day 7 |
|
| CREA [Above] at Day 42 |
|
| EOS [Unknown] at Day 0 |
|
| EOS [Unknown] at Day 7 |
|
| EOS [Unknown] at Day 42 |
|
| EOS [Below] at Day 0 |
|
| EOS [Below] at Day 7 |
|
| EOS [Below] at Day 42 |
|
| EOS [Within] at Day 0 |
|
| EOS [Within] at Day 7 |
|
| EOS [Within] at Day 42 |
|
| EOS [Above] at Day 0 |
|
| EOS [Above] at Day 7 |
|
| EOS [Above] at Day 42 |
|
| HB [Unknown] at Day 0 |
|
| HB [Unknown] at Day 7 |
|
| HB [Unknown] at Day 42 |
|
| HB [Below] at Day 0 |
|
| HB [Below] at Day 7 |
|
| HB [Below] at Day 42 |
|
| HB [Within] at Day 0 |
|
| HB [Within] at Day 7 |
|
| HB [Within] at Day 42 |
|
| HB [Above] at Day 0 |
|
| HB [Above] at Day 7 |
|
| HB[Above] at Day 42 |
|
| HC [Unknown] at Day 0 |
|
| HC [Unknown] at Day 7 |
|
| HC[Unknown] at Day 42 |
|
| HC [Below] at Day 0 |
|
| HC [Below] at Day 7 |
|
| HC [Below] at Day 42 |
|
| HC [Within] at Day 0 |
|
| HC [Within] at Day 7 |
|
| HC [Within] at Day 42 |
|
| HC [Above] at Day 0 |
|
| HC [Above] at Day 7 |
|
| HC [Above] at Day 42 |
|
| LYM [Unknown] at Day 42 |
|
| LYM [Below] at Day 0 |
|
| LYM [Below] at Day 7 |
|
| LYM [Below] at Day 42 |
|
| LYM [Within] at Day 0 |
|
| LYM [Within] at Day 7 |
|
| LYM [Within] at Day 42 |
|
| LYM [Above] at Day 0 |
|
| LYM [Above] at Day 7 |
|
| LYM [Above] at Day 42 |
|
| MON [Unknown] at Day 0 |
|
| MON [Unknown] at Day 7 |
|
| MON [Unknown] at Day 42 |
|
| MON [Below] at Day 0 |
|
| MON [Below] at Day 7 |
|
| MON [Below] at Day 42 |
|
| MON [Within] at Day 0 |
|
| MON [Within] at Day 7 |
|
| MON [Within] at Day 42 |
|
| MON [Above] at Day 0 |
|
| MON [Above] at Day 7 |
|
| MON [Above] at Day 42 |
|
| NEU [Unknown] at Day 0 |
|
| NEU [Unknown] at Day 7 |
|
| NEU [Unknown] at Day 42 |
|
| NEU [Below] at Day 0 |
|
| NEU [Below] at Day 7 |
|
| NEU [Below] at Day 42 |
|
| NEU [Within] at Day 0 |
|
| NEU [Within] at Day 7 |
|
| NEU [Within] at Day 42 |
|
| NEU [Above] at Day 0 |
|
| NEU [Above] at Day 7 |
|
| NEU [Above] at Day 42 |
|
| PLA [Unknown] at Day 42 |
|
| PLA [Below] at Day 0 |
|
| PLA [Below] at Day 7 |
|
| PLA [Below] at Day 42 |
|
| PLA [Within] at Day 0 |
|
| PLA [Within] at Day 7 |
|
| PLA [Within] at Day 42 |
|
| PLA [Above] at Day 0 |
|
| PLA [Above] at Day 7 |
|
| PLA [Above] at Day 42 |
|
| RBC [Unknown] at Day 0 |
|
| RBC [Unknown] at Day 7 |
|
| RBC[Unknown] at Day 42 |
|
| RBC [Below] at Day 0 |
|
| RBC [Below] at Day 7 |
|
| RBC [Below] at Day 42 |
|
| RBC [Within] at Day 0 |
|
| RBC [Within] at Day 7 |
|
| RBC [Within] at Day 42 |
|
| RBC [Above] at Day 0 |
|
| RBC[Above] at Day 7 |
|
| RBC[Above] at Day 42 |
|
| WBC[Unknown] at Day 0 |
|
| WBC [Unknown] at Day 7 |
|
| WBC [Unknown] at Day 42 |
|
| WBC [Below] at Day 0 |
|
| WBC [Below] at Day 7 |
|
| WBC [Below] at Day 42 |
|
| WBC [Within] at Day 0 |
|
| WBC [Within] at Day 7 |
|
| WBC [Within] at Day 42 |
|
| WBC [Above] at Day 0 |
|
| WBC [Above] at Day 7 |
|
| WBC [Above] at Day 42 |
|
| Blood [Negative] at Day 7 |
|
| Blood [Positive] at Day 7 |
|
| Blood [Negative] at Day 42 |
|
| Blood [Positive] at Day 42 |
|
| Glucose [Negative] at Day 0 |
|
| Glucose [Positive] at Day 0 |
|
| Glucose [Negative] at Day 7 |
|
| Glucose [Positive] at Day 7 |
|
| Glucose [Negative] at Day 42 |
|
| Glucose [Positive] at Day 42 |
|
| Protein [Negative] at Day 0 |
|
| Protein [Positive] at Day 0 |
|
| Protein [Negative] at Day 7 |
|
| Protein [Positive] at Day 7 |
|
| Protein [Negative] at Day 42 |
|
| Protein [Positive] at Day 42 |
|
| Urobilinogen [Negative] at Day 0 |
|
| Urobilinogen [Positive] at Day 0 |
|
| Urobilinogen [Negative] at Day 7 |
|
| Urobilinogen [Positive] at Day 7 |
|
| Urobilinogen [Negative] at Day 42 |
|
| Urobilinogen [Positive] at Day 42 |
|
| Any redness |
|
| Grade 3 redness |
|
| Any swelling/induration |
|
| Grade 3 swelling/induration |
|
| Related fatigue |
|
| Any headache |
|
| Grade 3 headache |
|
| Related headache |
|
| Any joint pain |
|
| Grade 3 joint pain |
|
| Related joint pain |
|
| Any muscle aches |
|
| Grade 3 muscle aches |
|
| Related muscle aches |
|
| Any shivering |
|
| Grade 3 shivering |
|
| Related shivering |
|
| Any increase sweating |
|
| Grade 3 increase sweating |
|
| Related increase sweating |
|
| Any fever |
|
| Grade 3 fever |
|
| Related fever |
|
| Related unsolicited AE (s) |
|
| Related unsolicited AE (s) |
|