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This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A, prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when administered up to 5 years following production.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza A (H5N1) Group | Experimental | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted | Biological | Intramuscular (IM), two doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease. | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus. | At Day 42 |
| Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease. | MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus. | At Day 42 |
| Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus. | At Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease. | A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10. | At Day 0 and Day 42 |
| Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease. |
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Inclusion Criteria:
Subjects who the investigator believes can and will comply with the requirements of the protocol.
A male or female 18 to 64 years of age at the time of the first vaccination.
Written informed consent obtained from the subject.
Stable general health as established by medical history and clinical examination before entering into the study.
Subject access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mesa | Arizona | 85213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25090645 | Derived | Godeaux O, Izurieta P, Madariaga M, Drame M, Li P, Vaughn DW. Immunogenicity and safety of AS03A-adjuvanted H5N1 influenza vaccine prepared from bulk antigen after stockpiling for 4 years. Vaccine. 2015 Apr 27;33(18):2189-95. doi: 10.1016/j.vaccine.2014.07.062. Epub 2014 Jul 30. |
| 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 |
|---|---|---|---|
| 112691 | 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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This study was conducted in two phases: the Primary Vaccination Phase (up to Day 84) and the Immunogenicity and Safety follow-up Phase (up to Day 385).
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| ID | Title | Description |
|---|---|---|
| FG000 | Influenza A (H5N1) Group | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Influenza A (H5N1) Group | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm. |
| 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 Subjects Against the H5N1 Strain of Influenza Disease. | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available. | Posted | Count of Participants | Participants | At Day 42 |
|
Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
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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) Group | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hernia obstructive | General disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA | 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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Titers are presented as geometric mean titers (GMTs). |
| At Day 0 and Day 42 |
| Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease. | A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10. | At Day 0 and Day 182 |
| Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). | At Day 0 and Day 182 |
| Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus. | At Day 0 and Day 182 |
| Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease. | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal HI titer (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus. | At Day 182 |
| Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease. | MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus. | At Day 182 |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities. Grade 3 Redness/Swelling = Redness/Swelling >100 millimeters (mm). | During the 7-day follow-up period (Days 0-6) after any vaccination |
| Duration of Solicited Local Symptoms After Vaccination. | Assessed solicited local symptoms were pain, redness and swelling. Duration was defined as the number of days with any grade of local symptoms. | During the 7-day (Days 0-6) post-vaccination period following each dose |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination. Any fever was defined as axillary temperature ≥ 38 degrees Celsius (°C). Grade 3 = general symptom that prevented normal activities. Grade 3 fever = fever ≥ 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination. | During the 7-day follow-up period (Days 0-6) after any vaccination |
| Duration of Solicited General Symptoms After Vaccination. | Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, increased sweating and shivering. Duration was defined as the number of days with any grade of general symptoms. | During the 7-day (Days 0-6) post-vaccination period following each dose |
| Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities Related = event assessed by the investigator as causally related to the study vaccination. | From Day 0 to Day 84 |
| Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination. | From Day 0 to Day 385 |
| Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs). | pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune aetiology. | From Day 0 to Day 84 and from Day 0 to Day 385 |
| Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents BAS, EOS and HCRIT results. | At Day 0 and Day 42 |
| Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents HBIN, LYM and MON results. | At Day 0 and Day 42 |
| Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents NEU, PLA and RBC results. | At Day 0 and Day 42 |
| Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents WBC, ALT and AST results. | At Day 0 and Day 42 |
| Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIL), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents Total BIL, BIL con/dir, CREA and BUN results. | At Day 0 and Day 42 |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an unsolicited AE regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination. | From Day 0 to Day 20 and from Day 0 to Day 84. |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) | A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | From Day 0 to Day 84 and from Day 0 to Day 385 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112691 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112691 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112691 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112691 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112691 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease. | MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available. | Posted | Geometric Mean | 95% Confidence Interval | ratio | At Day 42 |
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| Primary | Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available. | Posted | Count of Participants | Participants | At Day 42 |
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| Secondary | Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease. | A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available. | Posted | Count of Participants | Participants | At Day 0 and Day 42 |
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| Secondary | Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Day 0 and Day 42 |
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| Secondary | Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease. | A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10. | The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available. | Posted | Count of Participants | Participants | At Day 0 and Day 182 |
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| Secondary | Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). | The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Day 0 and Day 182 |
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| Secondary | Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus. | The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available. | Posted | Count of Participants | Participants | At Day 0 and Day 182 |
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| Secondary | Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease. | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal HI titer (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus. | The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available. | Posted | Count of Participants | Participants | At Day 182 |
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| Secondary | Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease. | MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus. | The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available. | Posted | Geometric Mean | 95% Confidence Interval | ratio | At Day 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 any solicited local symptoms regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities. Grade 3 Redness/Swelling = Redness/Swelling >100 millimeters (mm). | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination. | Posted | Count of Participants | Participants | During the 7-day follow-up period (Days 0-6) after any vaccination |
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| Secondary | Duration of Solicited Local Symptoms After Vaccination. | Assessed solicited local symptoms were pain, redness and swelling. Duration was defined as the number of days with any grade of local symptoms. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination, on subjects who experienced the specific symptom. | Posted | Median | Inter-Quartile Range | days | During the 7-day (Days 0-6) post-vaccination period following each dose |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination. Any fever was defined as axillary temperature ≥ 38 degrees Celsius (°C). Grade 3 = general symptom that prevented normal activities. Grade 3 fever = fever ≥ 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination. | Posted | Count of Participants | Participants | During the 7-day follow-up period (Days 0-6) after any vaccination |
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| Secondary | Duration of Solicited General Symptoms After Vaccination. | Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, increased sweating and shivering. Duration was defined as the number of days with any grade of general symptoms. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination, on subjects who experienced the specific symptom. | Posted | Median | Inter-Quartile Range | days | During the 7-day (Days 0-6) post-vaccination period following each dose |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities Related = event assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination. | Posted | Count of Participants | Participants | From Day 0 to Day 84 |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination. | Posted | Count of Participants | Participants | From Day 0 to Day 385 |
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| Secondary | Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs). | pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune aetiology. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination. | Posted | Count of Participants | Participants | From Day 0 to Day 84 and from Day 0 to Day 385 |
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| Secondary | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents BAS, EOS and HCRIT results. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination. | Posted | Count of Participants | Participants | At Day 0 and Day 42 |
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| Secondary | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents HBIN, LYM and MON results. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination. | Posted | Count of Participants | Participants | At Day 0 and Day 42 |
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| Secondary | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents NEU, PLA and RBC results. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination. | Posted | Count of Participants | Participants | At Day 0 and Day 42 |
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| Secondary | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents WBC, ALT and AST results. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination. | Posted | Count of Participants | Participants | At Day 0 and Day 42 |
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|
|
| Secondary | Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters. | Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIL), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents Total BIL, BIL con/dir, CREA and BUN results. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination. | Posted | Count of Participants | Participants | At Day 0 and Day 42 |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an unsolicited AE regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination. | Posted | Count of Participants | Participants | From Day 0 to Day 20 and from Day 0 to Day 84. |
|
|
|
| Secondary | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination. | Posted | Count of Participants | Participants | From Day 0 to Day 84 and from Day 0 to Day 385 |
|
|
|
| 3 |
| 78 |
| 74 |
| 78 |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Redness | General disorders | MedDRA | Systematic Assessment |
|
| Swelling | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal | General disorders | MedDRA | Systematic Assessment |
|
| Headache | General disorders | MedDRA | Systematic Assessment |
|
| Joint pain | General disorders | MedDRA | Systematic Assessment |
|
| Muscle aches | General disorders | MedDRA | Systematic Assessment |
|
| Shivering | General disorders | MedDRA | Systematic Assessment |
|
| Sweating | General disorders | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
|
|
|
| Title | Measurements |
|---|---|
|
| Grade 3 Pain |
|
| Grade 3 Redness |
|
| Grade 3 Swelling |
|
|
| Redness, Dose1 |
|
|
| Redness, Dose 2 |
|
|
| Swelling, Dose 1 |
|
|
| Swelling, Dose 2 |
|
|
| Title | Measurements |
|---|---|
|
| Any Gastrointestinal |
|
| Grade 3 Gastrointestinal |
|
| Related Gastrointestinal |
|
| 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 Sweating |
|
| Grade 3 Sweating |
|
| Related Sweating |
|
| Any Fever |
|
| Grade 3 Fever |
|
| Related Fever |
|
|
| Gastrointestinal, Dose 1 |
|
|
| Gastrointestinal, Dose 2 |
|
|
| Headache, Dose 1 |
|
|
| Headache, Dose 2 |
|
|
| Joint Pain, Dose 1 |
|
|
| Joint Pain, Dose 2 |
|
|
| Muscle aches, Dose 1 |
|
|
| Muscle aches, Dose 2 |
|
|
| Increased sweating, Dose 1 |
|
|
| Increased sweating, Dose 2 |
|
|
| Shivering, Dose 1 |
|
|
| Shivering, Dose 2 |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| BAS, below, Day 0 |
|
|
| BAS, below, Day 42 |
|
|
| BAS, within, Day 0 |
|
|
| BAS, within, Day 42 |
|
|
| BAS, above, Day 0 |
|
|
| BAS, above, Day 42 |
|
|
| EOS, unknown, Day 0 |
|
|
| EOS, unknown, Day 42 |
|
|
| EOS, below, Day 0 |
|
|
| EOS, below, Day 42 |
|
|
| EOS, within, Day 0 |
|
|
| EOS, within, Day 42 |
|
|
| EOS, above, Day 0 |
|
|
| EOS, above, Day 42 |
|
|
| HCRIT, unknown, Day 0 |
|
|
| HCRIT, unknown, Day 42 |
|
|
| HCRIT, below, Day 0 |
|
|
| HCRIT, below, Day 42 |
|
|
| HCRIT, within, Day 0 |
|
|
| HCRIT, within, Day 42 |
|
|
| HCRIT, above, Day 0 |
|
|
| HCRIT, above, Day 42 |
|
|
|
| HBIN, below, Day 0 |
|
|
| HBIN, below, Day 42 |
|
|
| HBIN, within, Day 0 |
|
|
| HBIN, within, Day 42 |
|
|
| HBIN, above, Day 0 |
|
|
| HBIN, above, Day 42 |
|
|
| LYM, unknown, Day 0 |
|
|
| LYM, unknown, Day 42 |
|
|
| LYM, below, Day 0 |
|
|
| LYM, below, Day 42 |
|
|
| LYM, within, Day 0 |
|
|
| LYM, within, Day 42 |
|
|
| LYM, above, Day 0 |
|
|
| LYM, above, Day 42 |
|
|
| MON, unknown, Day 0 |
|
|
| MON, unknown, Day 42 |
|
|
| MON, below, Day 0 |
|
|
| MON, below, Day 42 |
|
|
| MON, within, Day 0 |
|
|
| MON, within, Day 42 |
|
|
| MON, above, Day 0 |
|
|
| MON, above, Day 42 |
|
|
|
| NEU, below, Day 0 |
|
|
| NEU, below, Day 42 |
|
|
| NEU, within, Day 0 |
|
|
| NEU, within, Day 42 |
|
|
| NEU, above, Day 0 |
|
|
| NEU, above, Day 42 |
|
|
| PLA, unknown, Day 0 |
|
|
| PLA, unknown, Day 42 |
|
|
| PLA, below, Day 0 |
|
|
| PLA, below, Day 42 |
|
|
| PLA, within, Day 0 |
|
|
| PLA, within, Day 42 |
|
|
| PLA, above, Day 0 |
|
|
| PLA, above, Day 42 |
|
|
| RBC, unknown, Day 0 |
|
|
| RBC, unknown, Day 42 |
|
|
| RBC, below, Day 0 |
|
|
| RBC, below, Day 42 |
|
|
| RBC, within, Day 0 |
|
|
| RBC, within, Day 42 |
|
|
| RBC, above, Day 0 |
|
|
| RBC, above, Day 42 |
|
|
|
| WBC, below, Day 0 |
|
|
| WBC, below, Day 42 |
|
|
| WBC, within, Day 0 |
|
|
| WBC, within, Day 42 |
|
|
| WBC, above, Day 0 |
|
|
| WBC, above, Day 42 |
|
|
| ALT, unknown, Day 0 |
|
|
| ALT, unknown, Day 42 |
|
|
| ALT, below, Day 0 |
|
|
| ALT, below, Day 42 |
|
|
| ALT, within, Day 0 |
|
|
| ALT, within, Day 42 |
|
|
| ALT, above, Day 0 |
|
|
| ALT, above, Day 42 |
|
|
| AST, unknown, Day 0 |
|
|
| AST, unknown, Day 42 |
|
|
| AST, below, Day 0 |
|
|
| AST, below, Day 42 |
|
|
| AST, within, Day 0 |
|
|
| AST, within, Day 42 |
|
|
| AST, above, Day 0 |
|
|
| AST, above, Day 42 |
|
|
|
| Total BIL, below, Day 0 |
|
|
| Total BIL, below, Day 42 |
|
|
| Total BIL, within, Day 0 |
|
|
| Total BIL, within, Day 42 |
|
|
| Total BIL, above, Day 0 |
|
|
| Total BIL, above, Day 42 |
|
|
| BIL con/dir, unknown, Day 0 |
|
|
| BIL con/dir, unknown, Day 42 |
|
|
| BIL con/dir, below, Day 0 |
|
|
| BIL con/dir, below, Day 42 |
|
|
| BIL con/dir, within, Day 0 |
|
|
| BIL con/dir, within, Day 42 |
|
|
| BIL con/dir, above, Day 0 |
|
|
| BIL con/dir, above, Day 42 |
|
|
| CREA, unknown, Day 0 |
|
|
| CREA, unknown, Day 42 |
|
|
| CREA, below, Day 0 |
|
|
| CREA, below, Day 42 |
|
|
| CREA, within, Day 0 |
|
|
| CREA, within, Day 42 |
|
|
| CREA, above, Day 0 |
|
|
| CREA, above, Day 42 |
|
|
| BUN, unknown, Day 0 |
|
|
| BUN, unknown, Day 42 |
|
|
| BUN, below, Day 0 |
|
|
| BUN, below, Day 42 |
|
|
| BUN, within, Day 0 |
|
|
| BUN, within, Day 42 |
|
|
| BUN, above, Day 0 |
|
|
| BUN, above, Day 42 |
|
|
| Title | Measurements |
|---|---|
|
| Any unsolicited AEs [Days 0-84] |
|
| Grade 3 unsolicited AEs [Days 0-84] |
|
| Related unsolicited AEs [Days 0-84] |
|
| Title | Measurements |
|---|---|
|
| Related SAEs [Days 0-385] |
|