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The primary purpose of the study is to assess the equivalence of the immune response elicited by two GSK Biologicals' adjuvanted influenza investigational vaccines (GSK2340272A and GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate the safety and reactogenicity of these two vaccines.
This Protocol Posting has been updated following Protocol Amendment 4, July 2010, leading to removal of one of the secondary outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2340272A GROUP | Experimental | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
|
| GSK2340274A GROUP | Experimental | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine GSK2340272A | Biological | Two intramuscular injections at Day 0 and Day 21 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10. | At Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted (SCR) Subjects for HI Antibodies | Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). |
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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 | Caen | 14033 | France | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24041010 | Derived | Launay O, Duval X, Fitoussi S, Jilg W, Kerdpanich A, Montellano M, Schwarz TF, Watanveerade V, Wenzel JJ, Zalcman G, Bambure V, Li P, Caplanusi A, Madan A, Gillard P, Vaughn DW. Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials. BMC Infect Dis. 2013 Sep 16;13:435. doi: 10.1186/1471-2334-13-435. |
| 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 |
|---|---|---|---|
| 113535 | 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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Out of 336 subjects enrolled in the study, 2 subjects did not receive any vaccination.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2340272A GROUP | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| FG001 | GSK2340274A GROUP | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK2340272A GROUP | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| BG001 | GSK2340274A 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 | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who received 1 vaccine dose and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 21 |
|
Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK2340272A GROUP | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Influenza vaccine GSK2340274A | Biological | Two intramuscular injections at Day 0 and Day 21 |
|
| At Days 21 and 42 |
| Number of SCR Subjects for HI Antibodies | Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). | At Days 182 and 364 |
| Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. | At Days 0 and 42 |
| Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. | At Days 182 and 364 |
| Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. | At Days 0, 21 and 42 |
| Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. | At Days 182 and 364 |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. | At Days 21 and 42 |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. | At Days 182 and 364 |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
| Number of Days With Solicited Local Symptoms | The number of days with any solicited local symptoms reported during the solicited post-vaccination period. | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C and ≤ 40°C. Related = symptom assessed by the investigator as related to the vaccination. | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
| Number of Days With Solicited General Symptoms | The number of days with any solicited general symptoms reported during the solicited post-vaccination period. | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
| Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | A pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. | From Day 0 up to Day 42 |
| Number of Subjects With pIMDs | A pIMD 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 (from Day 0 up to Day 364) |
| Number of Subjects With Any Adverse Event of Special 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 (from Day 0 up to Day 364) |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | Within 21 days after the first vaccination (Days 0 - 20) and 63 days after the second vaccination (up to Day 84) |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period (from Day 0 up to Day 364) |
| Paris |
| 75679 |
| France |
| GSK Investigational Site | Paris | 75877 | France |
| GSK Investigational Site | Poitiers | 86000 | France |
| GSK Investigational Site | Regensburg | Bavaria | 93053 | Germany |
| GSK Investigational Site | Würzburg | Bavaria | 97070 | Germany |
| GSK Investigational Site | Schmiedeberg | Saxony | 01762 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113535 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113535 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113535 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113535 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113535 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | GSK2340274A GROUP | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
|
|
| Secondary | Number of Seroconverted (SCR) Subjects for HI Antibodies | Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). | The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose. | Posted | Count of Participants | Participants | At Days 21 and 42 |
|
|
|
| Secondary | Number of SCR Subjects for HI Antibodies | Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). | The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364. | Posted | Count of Participants | Participants | At Days 182 and 364 |
|
|
|
| Secondary | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. | The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Days 0 and 42 |
|
|
|
| Secondary | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. | The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Days 182 and 364 |
|
|
|
| Secondary | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. | The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose. | Posted | Count of Participants | Participants | At Days 0, 21 and 42 |
|
|
|
| Secondary | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. | The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364. | Posted | Count of Participants | Participants | At Days 182 and 364 |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. | The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Days 21 and 42 |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. | The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Days 182 and 364 |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects, who had their symptom sheets filled in. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
|
|
|
| Secondary | Number of Days With Solicited Local Symptoms | The number of days with any solicited local symptoms reported during the solicited post-vaccination period. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Median | Inter-Quartile Range | Days | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Doses with the symptom | Doses with the symptom |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C and ≤ 40°C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects, who had their symptom sheets filled in. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
|
|
|
| Secondary | Number of Days With Solicited General Symptoms | The number of days with any solicited general symptoms reported during the solicited post-vaccination period. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects. | Posted | Median | Inter-Quartile Range | Days | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Doses with the symptom | Doses with the symptom |
|
|
|
| Secondary | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | A pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects. | Posted | Count of Participants | Participants | From Day 0 up to Day 42 |
|
|
|
| Secondary | Number of Subjects With pIMDs | A pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 up to Day 364) |
|
|
|
| Secondary | Number of Subjects With Any Adverse Event of Special Interest (AESIs) | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 up to Day 364) |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects. | Posted | Count of Participants | Participants | Within 21 days after the first vaccination (Days 0 - 20) and 63 days after the second vaccination (up to Day 84) |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 up to Day 364) |
|
|
|
| 0 |
| 167 |
| 9 |
| 167 |
| 157 |
| 167 |
| EG001 | GSK2340274A GROUP | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | 0 | 167 | 11 | 167 | 159 | 167 |
| Thyroid mass | Endocrine disorders | MedDRA 13.1 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Perirectal abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Intervertebral disc injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Testicular injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 | Systematic Assessment |
|
| Abortion spontaneous incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 | Systematic Assessment |
|
| Adjustment disorder | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 13.1 | 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 |
| Flu A/CAL/7/09, Day 364 |
|
|
| Flu A/CAL/7/09, Day 364 |
|
|
| Flu A/CAL/7/09, Day 42 |
|
| Flu A/CAL/7/09, Day 364 |
|
|
| Flu A/CAL/7/09, Day 364 |
|
|
| Grade 3 Pain, Dose 1 |
|
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| Any Redness, Dose 1 |
|
|
| Grade 3 Redness, Dose 1 |
|
|
| Any Swelling, Dose 1 |
|
|
| Grade 3 Swelling, Dose 1 |
|
|
| Any Pain, Dose 2 |
|
|
| Grade 3 Pain, Dose 2 |
|
|
| Any Redness, Dose 2 |
|
|
| Grade 3 Redness, Dose 2 |
|
|
| Any Swelling, Dose 2 |
|
|
| Grade 3 Swelling, Dose 2 |
|
|
| Any Pain, Across doses |
|
|
| Grade 3 Pain, Across doses |
|
|
| Any Redness, Across doses |
|
|
| Grade 3 Redness, Across doses |
|
|
| Any Swelling, Across doses |
|
|
| Grade 3 Swelling, Across doses |
|
|
|
| Pain, Post-Dose 2 |
|
|
| Pain, Overall/dose |
|
|
| Redness, Post-Dose 1 |
|
|
| Redness, Post-Dose 2 |
|
|
| Redness, Overall/dose |
|
|
| Swelling, Post-Dose 1 |
|
|
| Swelling, Post-Dose 2 |
|
|
| Swelling, Overall/dose |
|
|
| Grade 3 Fatigue, Dose 1 |
|
|
| Related Fatigue, Dose 1 |
|
|
| Any Headache, Dose 1 |
|
|
| Grade 3 Headache, Dose 1 |
|
|
| Related Headache, Dose 1 |
|
|
| Any Joint pain, Dose 1 |
|
|
| Grade 3 Joint pain, Dose 1 |
|
|
| Related Joint pain, Dose 1 |
|
|
| Any Muscle aches, Dose 1 |
|
|
| Grade 3 Muscle aches, Dose 1 |
|
|
| Related Muscle aches, Dose 1 |
|
|
| Any Shivering, Dose 1 |
|
|
| Grade 3 Shivering, Dose 1 |
|
|
| Related Shivering, Dose 1 |
|
|
| Any Sweating, Dose 1 |
|
|
| Grade 3 Sweating, Dose 1 |
|
|
| Related Sweating, Dose 1 |
|
|
| Any Temperature, Dose 1 |
|
|
| Grade 3 Temperature, Dose 1 |
|
|
| Related Temperature, Dose 1 |
|
|
| Any Fatigue, Dose 2 |
|
|
| Grade 3 Fatigue, Dose 2 |
|
|
| Related Fatigue, Dose 2 |
|
|
| Any Headache, Dose 2 |
|
|
| Grade 3 Headache, Dose 2 |
|
|
| Related Headache, Dose 2 |
|
|
| Any Joint pain, Dose 2 |
|
|
| Grade 3 Joint pain, Dose 2 |
|
|
| Related Joint pain, Dose 2 |
|
|
| Any Muscle aches, Dose 2 |
|
|
| Grade 3 Muscle aches, Dose 2 |
|
|
| Related Muscle aches, Dose 2 |
|
|
| Any Shivering, Dose 2 |
|
|
| Grade 3 Shivering, Dose 2 |
|
|
| Related Shivering, Dose 2 |
|
|
| Any Sweating, Dose 2 |
|
|
| Grade 3 Sweating, Dose 2 |
|
|
| Related Sweating, Dose 2 |
|
|
| Any Temperature, Dose 2 |
|
|
| Grade 3 Temperature, Dose 2 |
|
|
| Related Temperature, Dose 2 |
|
|
| Any Fatigue, Across doses |
|
|
| Grade 3 Fatigue, Across doses |
|
|
| Related Fatigue, Across doses |
|
|
| Any Headache, Across doses |
|
|
| Grade 3 Headache, Across doses |
|
|
| Related Headache, Across doses |
|
|
| Any Joint pain, Across doses |
|
|
| Grade 3 Joint pain, Across doses |
|
|
| Related Joint pain, Across doses |
|
|
| Any Muscle aches, Across doses |
|
|
| Grade 3 Muscle aches, Across doses |
|
|
| Related Muscle aches, Across doses |
|
|
| Any Shivering, Across doses |
|
|
| Grade 3 Shivering, Across doses |
|
|
| Related Shivering, Across doses |
|
|
| Any Sweating, Across doses |
|
|
| Grade 3 Sweating, Across doses |
|
|
| Related Sweating, Across doses |
|
|
| Any Temperature, Across doses |
|
|
| Grade 3 Temperature, Across doses |
|
|
| Related Temperature, Across doses |
|
|
|
| Fatigue, Post-Dose 2 |
|
|
| Fatigue, Overall/dose |
|
|
| Headache, Post-Dose 1 |
|
|
| Headache, Post-Dose 2 |
|
|
| Headache, Overall/dose |
|
|
| Joint pain, Post-Dose 1 |
|
|
| Joint pain, Post-Dose 2 |
|
|
| Joint pain, Overall/dose |
|
|
| Muscle aches, Post-Dose 1 |
|
|
| Muscle aches, Post-Dose 2 |
|
|
| Muscle aches, Overall/dose |
|
|
| Sweating, Post-Dose 1 |
|
|
| Sweating, Post-Dose 2 |
|
|
| Sweating, Overall/dose |
|
|
| Shivering, Post-Dose 1 |
|
|
| Shivering, Post-Dose 2 |
|
|
| Shivering, Overall/dose |
|
|
| Temperature, Post-Dose 1 |
|
|
| Temperature, Post-Dose 2 |
|
|
| Temperature, Overall/dose |
|
|
| Related AE(s), Days 0-20 |
|
| Any AE(s), up to Day 84 |
|
| Grade 3 AE(s), up to Day 84 |
|
| Related AE(s), up to Day 84 |
|