Influenza
Conditions
Keywords
H7N1, AS03 adjuvant, Safety, Immunogenicity, Influenza, Adults, Elderly adults
Brief summary
The purpose of this placebo controlled study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 65 years of age and older. The study will evaluate safety related events and antibody immune responses to different formulations of study vaccine.
Interventions
BIOLOGICALInvestigational H7N1 vaccine GSK2789869A
Two doses of GSK2789869A H7N1 vaccine administered intramuscularly to the deltoid region at Day 0 and Day 21.
BIOLOGICALPlacebo
Two doses of placebo administered intramuscularly to the deltoid region at Day 0 and Day 21.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female adults who are 65 years of age and older at the time of first study vaccination. * Written informed consent obtained from the subject. * Subjects who the investigator believes can and will comply with the requirements of the protocol. * Stable health status, as established by medical history and physical exam, and defined by absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment. * Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
Exclusion criteria
* Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. * Presence or evidence of substance abuse. * Diagnosed with cancer, or treatment for cancer within three years. * Persons with a history of cancer who are disease-free without treatment for three years or more are eligible. * Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and are eligible, but other histologic types of skin cancer are exclusionary. * Women who are disease-free three years or more after treatment for breast cancer and receiving long-term prophylaxis are eligible. * Diagnosed with excessive daytime sleepiness (unintended sleep episodes during the day present almost daily for at least one month), or narcolepsy; or history of narcolepsy in subject's parent, sibling or child. * Presence of a temperature ≥ 38.0ºC (≥100.4ºF), or acute symptoms greater than mild severity on the scheduled date of first vaccination. * Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection. * Receipt of systemic glucocorticoids within 30 days prior to the first dose of study vaccine/placebo, or any other cytotoxic, immunosuppressive or immune-modifying drugs within 6 months of first study vaccine/placebo dose. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed. * Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible. * An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of receipt of prior seasonal or pandemic influenza vaccine. * Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first dose of study vaccine/placebo. * Planned administration of any vaccine other than the study vaccine/placebo before blood sampling at the Day 42 visit. * Previous administration of any H7 vaccine or physician-confirmed H7 disease. * Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. * Receipt of any immunoglobulins and/or any blood products within 90 days before the first dose of study vaccine/placebo, or planned administration of any of these products during the study period. * Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine including a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. * Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | At Day 42 | 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). |
| Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | At Day 42 | 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. |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | At Day 42 | 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. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | 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. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | 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. |
| Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | At Day 0 | 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 \[WBC\]. |
| Number of Subjects With Any Medically-attended Adverse Events (MAEs) | From Day 0 up to Day 42 | 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. |
| Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | From Day 0 up to Day 42 | 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. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | From Day 0 up to Day 42 | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 up to Day 42 | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | At Days 0, 21 and 42 and Month 6 | 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). |
| Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | At Days 0, 21 and 42 and at Month 6 | 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. |
| Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | At Days 21 and 42 and at Month 6 | 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). |
| Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | At Days 0, 21 and 42 and at Month 6 | 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). |
| Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | At Days 0, 21 and 42 and at Month 6 | 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. |
| Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | At Days 0, 21, 42 and Months 6 and 12 | 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). |
| Number of Subjects With Any Medically-attended Adverse Events (MAEs) | From Day 42 up to Month 12 | 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. |
| Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | From Day 42 up to Month 12 | 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. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 21-day (From Day 0 to Day 20) post-vaccination period after each dose | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (From Day 0 up to Month 12) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | At Days 21 and 42 and at Month 6 | 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). |
| Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | At Days 0, 21, 42 and Months 6 and 12 | 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). |
| Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | At Days 0, 21 and 42 and at Months 6 and 12 | 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). |
| Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | At Days 21 and 42 and at Months 6 and 12 | 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). |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | At Days 21 and 42 and at Months 6 and 12 | 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). |
| Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | At Days 0, 21 and 42 and at Months 6 and 12 | 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). |
| Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | At Days 0, 21 and 42 and at Months 6 and 12 | 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). |
| Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | At Days 0, 21 and 42 and at Months 6 and 12 | 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). |
| Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | At Days 21 and 42 and at Months 6 and 12 | 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). |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | At Days 21 and 42 and at Months 6 and 12 | 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). |
Countries
Canada, United States
Participant flow
Pre-assignment details
Out of 363 subjects enrolled in the study, 3 subjects did not receive any vaccination.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 60 |
| 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. | 60 |
| 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. | 60 |
| 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 the non-dominant arm at Day 0 and of the dominant arm at Day 21. | 120 |
| Total | 360 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 0 | 1 | 1 |
| Overall Study | Protocol non-compliance | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Serious Adverse Event | 0 | 1 | 2 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Placebo Group | GSK2789869A F4 Group | GSK2789869A F3 Group | GSK2789869A F2 Group | GSK2789869A F1 Group |
|---|---|---|---|---|---|---|
| Age, Continuous | 73.30 Years STANDARD_DEVIATION 5.75 | 73.0 Years STANDARD_DEVIATION 5.2 | 73.4 Years STANDARD_DEVIATION 5.3 | 73.6 Years STANDARD_DEVIATION 6.5 | 73.9 Years STANDARD_DEVIATION 6.3 | 72.9 Years STANDARD_DEVIATION 6 |
| Race/Ethnicity, Customized Geographic Ancestry African Heritage/African American | 14 Participants | 2 Participants | 3 Participants | 5 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Geographic Ancestry Asian - East Asian Heritage | 3 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Geographic Ancestry Asian - South East Asian Heritage | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Geographic Ancestry Other | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Geographic Ancestry White - Arabic/North African Heritage | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Geographic Ancestry White - Caucasian/European Heritage | 340 Participants | 116 Participants | 57 Participants | 52 Participants | 59 Participants | 56 Participants |
| Sex: Female, Male Female | 214 Participants | 76 Participants | 36 Participants | 30 Participants | 37 Participants | 35 Participants |
| Sex: Female, Male Male | 146 Participants | 44 Participants | 24 Participants | 30 Participants | 23 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 1 / 60 | 2 / 60 | 0 / 60 | 0 / 120 |
| other Total, other adverse events | 46 / 60 | 48 / 60 | 30 / 60 | 44 / 60 | 47 / 120 |
| serious Total, serious adverse events | 3 / 60 | 10 / 60 | 7 / 60 | 7 / 60 | 13 / 120 |
Outcome results
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.
Time frame: At Day 42
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2789869A F1 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 11.0 Fold increase |
| GSK2789869A F2 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 18.9 Fold increase |
| GSK2789869A F3 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 16.0 Fold increase |
| GSK2789869A F4 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 18.2 Fold increase |
| Placebo Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 1.0 Fold increase |
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).
Time frame: At Day 42
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2789869A F1 Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 39 Participants |
| GSK2789869A F2 Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 45 Participants |
| GSK2789869A F3 Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 42 Participants |
| GSK2789869A F4 Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 46 Participants |
| Placebo Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 0 Participants |
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.
Time frame: At Day 42
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2789869A F1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 39 Participants |
| GSK2789869A F2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 49 Participants |
| GSK2789869A F3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 43 Participants |
| GSK2789869A F4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 47 Participants |
| Placebo Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | 1 Participants |
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 \[WBC\].
Time frame: At Day 28
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 28.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT-Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 3 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT-Above | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 4 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 6 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 4 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT-Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 4 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT-Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 4 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 4 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 4 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 8 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 8 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 9 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT-Above | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 4 Participants |
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 \[WBC\].
Time frame: At Day 0
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 4 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 3 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 4 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 4 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 6 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 5 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 6 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 4 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 8 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 7 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 4 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 4 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 9 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 5 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 8 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 4 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 6 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 4 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 13 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 9 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 1 Participants |
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 \[WBC\].
Time frame: At Day 7
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 7.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 3 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 3 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 3 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 5 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 5 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 4 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 7 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 5 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 6 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 7 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 6 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 5 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 10 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 5 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 8 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 6 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
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 \[WBC\].
Time frame: At Day 21
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 21.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 4 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 4 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 5 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 4 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 4 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 3 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 6 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 7 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 4 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 6 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 7 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 5 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 4 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 10 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 4 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 4 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 5 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 4 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 8 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 9 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 7 Participants |
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 \[WBC\].
Time frame: At Day 42
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 42.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 3 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 3 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 4 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 7 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 4 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 6 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 10 Participants |
| GSK2789869A F2 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 9 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 8 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 4 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Below | 5 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Above | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Above | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | RBC- Below | 1 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Below | 4 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Below | 10 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | LYM- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | PLA- Above | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Below | 7 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | BAS- Above | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Below | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | AST- Below | 0 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | EOS- Above | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Above | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HEM- Above | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Above | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | MON- Below | 18 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | WBC- Below | 2 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | CRE- Above | 8 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | HgB- Below | 3 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | ALT- Above | 6 Participants |
| Placebo Group | Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values | NEU- Below | 0 Participants |
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.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 27 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 27 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 38 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 34 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 3 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 24 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 39 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 4 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 17 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 4 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 16 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 25 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 25 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 4 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 38 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 4 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 29 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 1 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 1 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 7 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 3 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 8 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
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.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 3 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 5 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 10 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 9 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 7 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 12 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 5 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 3 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 4 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 11 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 3 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 9 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 13 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 10 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 4 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 6 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 6 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 8 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 3 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 14 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 4 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 6 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 11 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 8 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 7 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 3 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 8 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 3 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 7 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 10 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 9 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 3 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 7 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 5 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 13 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 9 Participants |
| GSK2789869A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 21 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 4 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 10 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 4 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 5 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 12 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 3 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 4 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 9 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 3 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 14 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 10 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 12 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 11 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 19 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 8 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 5 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 10 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 4 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 17 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 3 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 9 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 11 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 6 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 11 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 13 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 17 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 13 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 13 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 5 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 7 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 5 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 6 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 3 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 13 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 7 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 10 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 8 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 8 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 9 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 7 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 10 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 10 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 13 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 6 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 10 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 7 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 4 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 9 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 6 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 2 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 9 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 8 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 4 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 5 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 4 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 8 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 7 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 8 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 5 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 9 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 11 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 8 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 6 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 11 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 8 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 11 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 11 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 6 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 5 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 5 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 16 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 5 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 9 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 4 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 13 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 8 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 4 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 8 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 6 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 5 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 6 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 4 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 4 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 9 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 19 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 12 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 16 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 7 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 24 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 6 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 12 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 8 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 13 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 22 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 4 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 5 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 10 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 16 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 11 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 6 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 17 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 12 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 6 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 17 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 14 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 17 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 28 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 12 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 7 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 9 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 7 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 10 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 9 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 7 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 20 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 13 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 10 Participants |
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.
Time frame: From Day 0 up to Day 42
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 2 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 10 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 7 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 3 Participants |
| Placebo Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 16 Participants |
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.
Time frame: From Day 0 up to Day 42
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| Placebo Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
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.
Time frame: From Day 0 up to Day 42
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 17 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 18 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 21 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 17 Participants |
| Placebo Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 35 Participants |
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.
Time frame: From Day 0 up to Day 42
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
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).
Time frame: At Days 21 and 42 and at Months 6 and 12
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2789869A F1 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 1.6 Fold increase |
| GSK2789869A F1 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 11.0 Fold increase |
| GSK2789869A F1 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 2.1 Fold increase |
| GSK2789869A F1 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 1.1 Fold increase |
| GSK2789869A F2 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 1.6 Fold increase |
| GSK2789869A F2 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 1.1 Fold increase |
| GSK2789869A F2 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 18.9 Fold increase |
| GSK2789869A F2 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 3.0 Fold increase |
| GSK2789869A F3 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 1.3 Fold increase |
| GSK2789869A F3 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 16.0 Fold increase |
| GSK2789869A F3 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 3.2 Fold increase |
| GSK2789869A F3 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 2.1 Fold increase |
| GSK2789869A F4 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 2.1 Fold increase |
| GSK2789869A F4 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 18.2 Fold increase |
| GSK2789869A F4 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 1.4 Fold increase |
| GSK2789869A F4 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 3.4 Fold increase |
| Placebo Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 1.0 Fold increase |
| Placebo Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 1.0 Fold increase |
| Placebo Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 1.0 Fold increase |
| Placebo Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 1.0 Fold increase |
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).
Time frame: At Days 21 and 42 and at Months 6 and 12
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2789869A F1 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 1.5 Fold increase |
| GSK2789869A F1 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 14.1 Fold increase |
| GSK2789869A F1 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 1.8 Fold increase |
| GSK2789869A F1 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 1.1 Fold increase |
| GSK2789869A F2 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 2.3 Fold increase |
| GSK2789869A F2 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 1.6 Fold increase |
| GSK2789869A F2 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 37.7 Fold increase |
| GSK2789869A F2 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 2.6 Fold increase |
| GSK2789869A F3 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 1.7 Fold increase |
| GSK2789869A F3 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 18.4 Fold increase |
| GSK2789869A F3 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 2.8 Fold increase |
| GSK2789869A F3 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 1.9 Fold increase |
| GSK2789869A F4 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 1.7 Fold increase |
| GSK2789869A F4 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 28.7 Fold increase |
| GSK2789869A F4 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 1.2 Fold increase |
| GSK2789869A F4 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 2.0 Fold increase |
| Placebo Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 1.0 Fold increase |
| Placebo Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 1.0 Fold increase |
| Placebo Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 1.0 Fold increase |
| Placebo Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 1.0 Fold increase |
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).
Time frame: At Days 21 and 42 and at Months 6 and 12
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 2 Participants |
| GSK2789869A F1 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 22 Participants |
| GSK2789869A F1 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 2 Participants |
| GSK2789869A F1 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 0 Participants |
| GSK2789869A F2 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 8 Participants |
| GSK2789869A F2 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 3 Participants |
| GSK2789869A F2 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 26 Participants |
| GSK2789869A F2 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 5 Participants |
| GSK2789869A F3 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 2 Participants |
| GSK2789869A F3 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 23 Participants |
| GSK2789869A F3 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 6 Participants |
| GSK2789869A F3 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 3 Participants |
| GSK2789869A F4 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 4 Participants |
| GSK2789869A F4 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 22 Participants |
| GSK2789869A F4 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 1 Participants |
| GSK2789869A F4 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 2 Participants |
| Placebo Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 0 Participants |
| Placebo Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 0 Participants |
| Placebo Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 0 Participants |
| Placebo Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 0 Participants |
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).
Time frame: At Days 21 and 42 and at Months 6 and 12
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 7 Participants |
| GSK2789869A F1 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 39 Participants |
| GSK2789869A F1 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 10 Participants |
| GSK2789869A F1 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 2 Participants |
| GSK2789869A F2 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 4 Participants |
| GSK2789869A F2 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 1 Participants |
| GSK2789869A F2 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 45 Participants |
| GSK2789869A F2 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 15 Participants |
| GSK2789869A F3 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 1 Participants |
| GSK2789869A F3 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 42 Participants |
| GSK2789869A F3 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 15 Participants |
| GSK2789869A F3 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 9 Participants |
| GSK2789869A F4 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 8 Participants |
| GSK2789869A F4 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 46 Participants |
| GSK2789869A F4 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 3 Participants |
| GSK2789869A F4 Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 14 Participants |
| Placebo Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 0 Participants |
| Placebo Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 0 Participants |
| Placebo Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 0 Participants |
| Placebo Group | Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 0 Participants |
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).
Time frame: At Days 0, 21 and 42 and at Months 6 and 12
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 2 Participants |
| GSK2789869A F1 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 0 Participants |
| GSK2789869A F1 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 0 Participants |
| GSK2789869A F1 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 2 Participants |
| GSK2789869A F1 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 22 Participants |
| GSK2789869A F2 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 5 Participants |
| GSK2789869A F2 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 26 Participants |
| GSK2789869A F2 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 9 Participants |
| GSK2789869A F2 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 3 Participants |
| GSK2789869A F2 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 0 Participants |
| GSK2789869A F3 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 23 Participants |
| GSK2789869A F3 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 0 Participants |
| GSK2789869A F3 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 4 Participants |
| GSK2789869A F3 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 6 Participants |
| GSK2789869A F3 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 2 Participants |
| GSK2789869A F4 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 1 Participants |
| GSK2789869A F4 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 1 Participants |
| GSK2789869A F4 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 3 Participants |
| GSK2789869A F4 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 23 Participants |
| GSK2789869A F4 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 6 Participants |
| Placebo Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 0 Participants |
| Placebo Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 0 Participants |
| Placebo Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 0 Participants |
| Placebo Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 0 Participants |
| Placebo Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 0 Participants |
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).
Time frame: At Days 0, 21 and 42 and at Months 6 and 12
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 2 Participants |
| GSK2789869A F1 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 7 Participants |
| GSK2789869A F1 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 10 Participants |
| GSK2789869A F1 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 39 Participants |
| GSK2789869A F1 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 0 Participants |
| GSK2789869A F2 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 6 Participants |
| GSK2789869A F2 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 17 Participants |
| GSK2789869A F2 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 1 Participants |
| GSK2789869A F2 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 1 Participants |
| GSK2789869A F2 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 49 Participants |
| GSK2789869A F3 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 43 Participants |
| GSK2789869A F3 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 17 Participants |
| GSK2789869A F3 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 1 Participants |
| GSK2789869A F3 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 9 Participants |
| GSK2789869A F3 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 0 Participants |
| GSK2789869A F4 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 14 Participants |
| GSK2789869A F4 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 0 Participants |
| GSK2789869A F4 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 8 Participants |
| GSK2789869A F4 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 47 Participants |
| GSK2789869A F4 Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 3 Participants |
| Placebo Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 1 Participants |
| Placebo Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 1 Participants |
| Placebo Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 1 Participants |
| Placebo Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 0 Participants |
| Placebo Group | Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 0 Participants |
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.
Time frame: From Day 42 up to Month 12
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 23 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 24 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 26 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 21 Participants |
| Placebo Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 43 Participants |
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.
Time frame: From Day 42 up to Month 12
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 1 Participants |
| Placebo Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
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.
Time frame: During the 21-day (From Day 0 to Day 20) post-vaccination period after each dose
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 18 Participants |
| GSK2789869A F2 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 17 Participants |
| GSK2789869A F3 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 22 Participants |
| GSK2789869A F4 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 17 Participants |
| Placebo Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 38 Participants |
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).
Time frame: At Days 0, 21 and 42 and at Months 6 and 12
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 10 Participants |
| GSK2789869A F1 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 6 Participants |
| GSK2789869A F1 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 24 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 19 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 27 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 13 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 11 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 24 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 1 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 12 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 18 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 11 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 4 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 14 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 24 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 9 Participants |
| Placebo Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 1 Participants |
| Placebo Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 0 Participants |
| Placebo Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 1 Participants |
| Placebo Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 1 Participants |
| Placebo Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 1 Participants |
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).
Time frame: At Days 0, 21, 42 and Months 6 and 12
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 25 Participants |
| GSK2789869A F1 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 4 Participants |
| GSK2789869A F1 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 16 Participants |
| GSK2789869A F1 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 47 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 37 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 56 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 18 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 7 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 4 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 50 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 3 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 25 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 35 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 9 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 10 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 1 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 38 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 48 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 23 Participants |
| Placebo Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 7 Participants |
| Placebo Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 4 Participants |
| Placebo Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 3 Participants |
| Placebo Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 1 Participants |
| Placebo Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 4 Participants |
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).
Time frame: At Days 0, 21 and 42 and at Month 6
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 0 | 0 Participants |
| GSK2789869A F1 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 21 | 3 Participants |
| GSK2789869A F1 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 42 | 25 Participants |
| GSK2789869A F1 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Month 6 | 16 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 0 | 1 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Month 6 | 23 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 21 | 12 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 42 | 27 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Month 6 | 22 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 21 | 7 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 42 | 23 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 0 | 0 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 0 | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 21 | 12 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Month 6 | 20 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 42 | 24 Participants |
| Placebo Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Month 6 | 1 Participants |
| Placebo Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 42 | 0 Participants |
| Placebo Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 21 | 0 Participants |
| Placebo Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 0 | 0 Participants |
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).
Time frame: At Days 0, 21 and 42 and Month 6
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 2 Participants |
| GSK2789869A F1 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 9 Participants |
| GSK2789869A F1 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 26 Participants |
| GSK2789869A F1 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 22 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 7 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 27 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 13 Participants |
| GSK2789869A F2 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 27 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 23 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 9 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 24 Participants |
| GSK2789869A F3 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 3 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 2 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 12 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 20 Participants |
| GSK2789869A F4 Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 24 Participants |
| Placebo Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 3 Participants |
| Placebo Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 2 Participants |
| Placebo Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 2 Participants |
| Placebo Group | Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 3 Participants |
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.
Time frame: During the entire study period (From Day 0 up to Month 12)
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2789869A F1 Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| GSK2789869A F2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 10 Participants |
| GSK2789869A F3 Group | Number of Subjects With Serious Adverse Events (SAEs) | 7 Participants |
| GSK2789869A F4 Group | Number of Subjects With Serious Adverse Events (SAEs) | 7 Participants |
| Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | 13 Participants |
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.
Time frame: At Days 0, 21 and 42 and at Month 6
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2789869A F1 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 0 | 14.0 Titers |
| GSK2789869A F1 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 21 | 15.1 Titers |
| GSK2789869A F1 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 42 | 44.0 Titers |
| GSK2789869A F1 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Month 6 | 24.8 Titers |
| GSK2789869A F2 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 0 | 14.4 Titers |
| GSK2789869A F2 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Month 6 | 34.2 Titers |
| GSK2789869A F2 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 21 | 20.1 Titers |
| GSK2789869A F2 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 42 | 79.1 Titers |
| GSK2789869A F3 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Month 6 | 36.1 Titers |
| GSK2789869A F3 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 21 | 16.5 Titers |
| GSK2789869A F3 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 42 | 53.8 Titers |
| GSK2789869A F3 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 0 | 14.0 Titers |
| GSK2789869A F4 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 0 | 14.8 Titers |
| GSK2789869A F4 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 21 | 21.3 Titers |
| GSK2789869A F4 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Month 6 | 35.9 Titers |
| GSK2789869A F4 Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 42 | 85.6 Titers |
| Placebo Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Month 6 | 14.3 Titers |
| Placebo Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 42 | 14.0 Titers |
| Placebo Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 21 | 14.0 Titers |
| Placebo Group | Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) | Flu A/Anhui/1/2013 (H7N9), Day 0 | 14.0 Titers |
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).
Time frame: At Days 0, 21, 42 and Months 6 and 12
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2789869A F1 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 10.7 Titers |
| GSK2789869A F1 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 5.0 Titers |
| GSK2789869A F1 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 5.7 Titers |
| GSK2789869A F1 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 8.2 Titers |
| GSK2789869A F1 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 55.0 Titers |
| GSK2789869A F2 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 16.1 Titers |
| GSK2789869A F2 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 104.8 Titers |
| GSK2789869A F2 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 8.9 Titers |
| GSK2789869A F2 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 5.9 Titers |
| GSK2789869A F2 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 5.6 Titers |
| GSK2789869A F3 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 85.5 Titers |
| GSK2789869A F3 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 5.4 Titers |
| GSK2789869A F3 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 11.1 Titers |
| GSK2789869A F3 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 17.1 Titers |
| GSK2789869A F3 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 6.6 Titers |
| GSK2789869A F4 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 7.2 Titers |
| GSK2789869A F4 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 5.1 Titers |
| GSK2789869A F4 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 17.5 Titers |
| GSK2789869A F4 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 97.0 Titers |
| GSK2789869A F4 Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 10.6 Titers |
| Placebo Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 5.4 Titers |
| Placebo Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 5.2 Titers |
| Placebo Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 5.2 Titers |
| Placebo Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 12 | 5.0 Titers |
| Placebo Group | Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 5.3 Titers |
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).
Time frame: At Days 0, 21 and 42 and at Months 6 and 12
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2789869A F1 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 8.6 Titers |
| GSK2789869A F1 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 5.0 Titers |
| GSK2789869A F1 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 5.6 Titers |
| GSK2789869A F1 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 7.6 Titers |
| GSK2789869A F1 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 64.3 Titers |
| GSK2789869A F2 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 14.1 Titers |
| GSK2789869A F2 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 201.3 Titers |
| GSK2789869A F2 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 12.5 Titers |
| GSK2789869A F2 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 8.4 Titers |
| GSK2789869A F2 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 5.3 Titers |
| GSK2789869A F3 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 96.4 Titers |
| GSK2789869A F3 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 5.2 Titers |
| GSK2789869A F3 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 10.0 Titers |
| GSK2789869A F3 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 14.7 Titers |
| GSK2789869A F3 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 9.0 Titers |
| GSK2789869A F4 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 7.0 Titers |
| GSK2789869A F4 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 5.8 Titers |
| GSK2789869A F4 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 12.6 Titers |
| GSK2789869A F4 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 179.9 Titers |
| GSK2789869A F4 Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 10.9 Titers |
| Placebo Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 42 | 5.2 Titers |
| Placebo Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 6 | 5.0 Titers |
| Placebo Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 0 | 5.2 Titers |
| Placebo Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Month 12 | 5.4 Titers |
| Placebo Group | Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) | Flu A/Shanghai/2/2013 (H7N9), Day 21 | 5.2 Titers |
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.
Time frame: At Days 0, 21 and 42 and at Month 6
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2789869A F1 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 14.7 Titers |
| GSK2789869A F1 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 17.5 Titers |
| GSK2789869A F1 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 46.2 Titers |
| GSK2789869A F1 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 26.7 Titers |
| GSK2789869A F2 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 16.8 Titers |
| GSK2789869A F2 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 38.5 Titers |
| GSK2789869A F2 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 21.2 Titers |
| GSK2789869A F2 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 71.4 Titers |
| GSK2789869A F3 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 33.5 Titers |
| GSK2789869A F3 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 18.2 Titers |
| GSK2789869A F3 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 51.3 Titers |
| GSK2789869A F3 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 15.0 Titers |
| GSK2789869A F4 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 14.8 Titers |
| GSK2789869A F4 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 21.9 Titers |
| GSK2789869A F4 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 39.4 Titers |
| GSK2789869A F4 Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 74.7 Titers |
| Placebo Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 15.0 Titers |
| Placebo Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 14.7 Titers |
| Placebo Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 14.7 Titers |
| Placebo Group | Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) | Flu A/mallard/NL/12/2000 (H7N1), Day 0 | 15.0 Titers |
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).
Time frame: At Days 21 and 42 and at Month 6
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Day 21 | 0 Participants |
| GSK2789869A F1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Month 6 | 6 Participants |
| GSK2789869A F1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Day 42 | 13 Participants |
| GSK2789869A F2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Day 42 | 23 Participants |
| GSK2789869A F2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Day 21 | 2 Participants |
| GSK2789869A F2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Month 6 | 12 Participants |
| GSK2789869A F3 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Day 42 | 18 Participants |
| GSK2789869A F3 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Day 21 | 0 Participants |
| GSK2789869A F3 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Month 6 | 13 Participants |
| GSK2789869A F4 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Day 21 | 3 Participants |
| GSK2789869A F4 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Month 6 | 11 Participants |
| GSK2789869A F4 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Day 42 | 18 Participants |
| Placebo Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Day 42 | 0 Participants |
| Placebo Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Day 21 | 0 Participants |
| Placebo Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain | Flu A/Anhui/1/2013 (H7N9), Month 6 | 0 Participants |
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).
Time frame: At Days 21 and 42 and at Month 6
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2789869A F1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 0 Participants |
| GSK2789869A F1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 4 Participants |
| GSK2789869A F1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 13 Participants |
| GSK2789869A F2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 0 Participants |
| GSK2789869A F2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 9 Participants |
| GSK2789869A F2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 22 Participants |
| GSK2789869A F3 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 17 Participants |
| GSK2789869A F3 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 10 Participants |
| GSK2789869A F3 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 1 Participants |
| GSK2789869A F4 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 19 Participants |
| GSK2789869A F4 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 3 Participants |
| GSK2789869A F4 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 13 Participants |
| Placebo Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Day 21 | 0 Participants |
| Placebo Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Day 42 | 0 Participants |
| Placebo Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain | Flu A/mallard/NL/12/2000 (H7N1), Month 6 | 0 Participants |