| Primary | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/mallard/Netherlands/12/2000 NIBRG-63 (H7N1) (Flu A/mallard/NL/12/2000 H7N1). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. This primary outcome measure was centered on the groups that received GSK2789869A vaccine. | Posted | | Count of Participants | | Participants | | At Day 42 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG003 | GSK2789869A F4 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG004 | Placebo Group | Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| | Units | Counts |
|---|
| Participants | - OG00056
- OG00156
- OG00255
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00039
- OG00145
- OG00242
- OG003
|
|
| |
| Primary | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) 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 for whom data concerning immunogenicity outcome measure were available. This primary outcome measure was centered on the groups that received GSK2789869A vaccine. | Posted | | Count of Participants | | Participants | | At Day 42 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group | |
|
| Primary | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | GMFR, also known as seroconversion factor (SCR) or mean geometric increase (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 ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. This primary outcome was centered on the groups that received GSK2789869A vaccine. | Posted | | Geometric Mean | 95% Confidence Interval | Fold increase | | At Day 42 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group |
|
| Primary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group |
|
| Primary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 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. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
|
| Primary | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. | The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available. | Posted | | Count of Participants | | Participants | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group | |
|
| Primary | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. | The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 7. | Posted | | Count of Participants | | Participants | | At Day 7 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group | |
|
| Primary | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. | The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 21. | Posted | | Count of Participants | | Participants | | At Day 21 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group | |
|
| Primary | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. | The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 28. | Posted | | Count of Participants | | Participants | | At Day 28 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group | |
|
| Primary | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. | The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 42. | Posted | | Count of Participants | | Participants | | At Day 42 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group | |
|
| Primary | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available. | Posted | | Count of Participants | | Participants | | From Day 0 up to Day 42 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
|
| Primary | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | Any 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 (TVc), which included all vaccinated subjects for whom safety data were available. | Posted | | Count of Participants | | Participants | | From Day 0 up to Day 42 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
|
| Primary | Number of Subjects With Any 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. | The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available. | Posted | | Count of Participants | | Participants | | From Day 0 up to Day 42 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 |
|
| Primary | 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 (TVc), which included all vaccinated subjects for whom safety data were available. | Posted | | Count of Participants | | Participants | | From Day 0 up to Day 42 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), 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 Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1). | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively. | Posted | | Count of Participants | | Participants | | At Days 0, 21, 42 and Months 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group |
|
| Secondary | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1). | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Days 0, 21, 42 and Months 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 |
|
| Secondary | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Seroprotection (SPR) was defined as the proportion of subjects with H7N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1). | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively. | Posted | | Count of Participants | | Participants | | At Days 0, 21 and 42 and at Months 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 |
|
| Secondary | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1). | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively. | Posted | | Count of Participants | | Participants | | At Days 21 and 42 and at Months 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
|
| Secondary | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1). | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively. | Posted | | Geometric Mean | 95% Confidence Interval | Fold increase | | At Days 21 and 42 and at Months 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), 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 Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9). | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively. | Posted | | Count of Participants | | Participants | | At Days 0, 21 and 42 and at Months 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 |
|
| Secondary | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9). | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Days 0, 21 and 42 and at Months 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 |
|
| Secondary | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Seroprotection (SPR) was defined as the proportion of subjects with H7N9 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9). | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively. | Posted | | Count of Participants | | Participants | | At Days 0, 21 and 42 and at Months 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 |
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| Secondary | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9). | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively. | Posted | | Count of Participants | | Participants | | At Days 21 and 42 and at Months 6 and 12 | | | | ID | Title | Description |
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| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
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| Secondary | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9). | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively. | Posted | | Geometric Mean | 95% Confidence Interval | Fold increase | | At Days 21 and 42 and at Months 6 and 12 | | | | ID | Title | Description |
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| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
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| Secondary | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1). | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6. | Posted | | Count of Participants | | Participants | | At Days 0, 21 and 42 and Month 6 | | | | ID | Title | Description |
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| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group |
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| Secondary | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/mallard/NL/12/2000. The reference seropositivity cut-off value was ≥ 1:28. | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Days 0, 21 and 42 and at Month 6 | | | | ID | Title | Description |
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| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group |
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| Secondary | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Vaccine response was defined as: For initially seronegative subjects antibody titer ≥ 1:56 at post-vaccination]; For initially seropositive subjects antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1). | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 21 and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6. | Posted | | Count of Participants | | Participants | | At Days 21 and 42 and at Month 6 | | | | ID | Title | Description |
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| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | |
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| Secondary | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Anhui/1/2013 (H7N9). | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21 and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6. | Posted | | Count of Participants | | Participants | | At Days 0, 21 and 42 and at Month 6 | | | | ID | Title | Description |
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| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group |
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| Secondary | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Anhui/1/2013. The reference seropositivity cut-off value was ≥ 1:28. | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Days 0, 21 and 42 and at Month 6 | | | | ID | Title | Description |
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| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group |
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| Secondary | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Vaccine response was defined as: For initially seronegative subjects antibody titer ≥ 1:56 at post-vaccination]; For initially seropositive subjects antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Anhui/1/2013 (H7N9). | The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 21 and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6. | Posted | | Count of Participants | | Participants | | At Days 21 and 42 and at Month 6 | | | | ID | Title | Description |
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| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | |
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| Secondary | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. | The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available. | Posted | | Count of Participants | | Participants | | From Day 42 up to Month 12 | | | | ID | Title | Description |
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| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group |
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| Secondary | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | An 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 (TVc), which included all vaccinated subjects for whom safety data were available. | Posted | | Count of Participants | | Participants | | From Day 42 up to Month 12 | | | | ID | Title | Description |
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| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
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| Secondary | Number of Subjects With Any 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. | The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available. | Posted | | Count of Participants | | Participants | | During the 21-day (From Day 0 to Day 20) post-vaccination period after each dose | | | | ID | Title | Description |
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| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
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| 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 (TVc), which included all vaccinated subjects for whom safety data were available. | Posted | | Count of Participants | | Participants | | During the entire study period (From Day 0 up to Month 12) | | | | ID | Title | Description |
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| OG000 | GSK2789869A F1 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG001 | GSK2789869A F2 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | | OG002 | GSK2789869A F3 Group | Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
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