Influenza
Conditions
Keywords
Primary study, immunogenicity, safety
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
Interventions
BIOLOGICALGSK Biologicals' quadrivalent influenza vaccine
Single intramuscular dose on Day 0.
BIOLOGICALGSK Biologicals' trivalent influenza vaccine
Single intramuscular dose on Day 0.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects as established by medical history and clinical examination before entering into the study. * Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 18 and 60 years of age at the time of the vaccination. * Written informed consent obtained from the subject. * If the subject is female, she must be of non-childbearing potential, if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine. * Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination. * Confirmed influenza infection within a year preceding the study start. * Administration of an influenza vaccine during Northern Hemisphere season 2007-2008. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * History of hypersensitivity to a previous dose of influenza vaccine * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). * Acute disease at the time of enrolment. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * History of chronic alcohol consumption and/or drug abuse. * Any condition which, in the opinion of the investigator, prevents the subject from participating in the study. * History of administration of experimental/licensed vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | At Day 0 and Day 21 | Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | Day 21 | Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens. |
| Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | At Days 0 and 21 | A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | During a 7 day (Days 0-6) follow-up period after vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | During a 7-day follow-up period (Days 0-6) after vaccination | Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). |
| Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | At Day 21 | A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens. |
| Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | During a 7-day follow-up period (Days 0-6) after vaccination | Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 °C. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature above 39.0°C. . Related = symptoms considered by the investigator to have a causal relationship to vaccination. |
| Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs). | During the entire study period (Days 0-180) | MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | During a 21 day (Days 0-20) follow-up period after vaccination- | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | During the entire study period (Days 0-180) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | During a 7-day follow-up period (Days 0-6) after vaccination | Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 | 105 |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 | 105 |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 | 105 |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 | 105 |
| Total | 420 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 0 | 1 |
| Overall Study | Migrated/moved from study area | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Trivalent Influenza Vaccine GSK 2115160A Group 1 | Trivalent Influenza Vaccine GSK 2115160A Group 2 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 38.5 Years STANDARD_DEVIATION 11.85 | 37.6 Years STANDARD_DEVIATION 12.3 | 36.6 Years STANDARD_DEVIATION 12.87 | 37.4 Years STANDARD_DEVIATION 12.51 | 37.5 Years STANDARD_DEVIATION 12.36 |
| Sex: Female, Male Female | 61 Participants | 66 Participants | 66 Participants | 58 Participants | 251 Participants |
| Sex: Female, Male Male | 44 Participants | 39 Participants | 39 Participants | 47 Participants | 169 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 84 / 105 | 90 / 105 | 81 / 105 | 72 / 105 |
| serious Total, serious adverse events | 0 / 105 | 0 / 105 | 0 / 105 | 1 / 105 |
Outcome results
Primary
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.
Time frame: At Day 0 and Day 21
Population: Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Wisconsin strain, Day 0 | 29.3 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Solomon Islands strain, Day 21 | 130.0 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Jiangsu strain, Day 21 | 179.1 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Solomon Islands strain, Day 0 | 21.4 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Wisconsin strain, Day 21 | 162.1 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Malaysia strain, Day 0 | 32.2 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Malaysia strain, Day 21 | 192.8 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Jiangsu strain, Day 0 | 19.6 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Solomon Islands strain, Day 21 | 150.6 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Wisconsin strain, Day 0 | 25.7 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Wisconsin strain, Day 21 | 189.5 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Solomon Islands strain, Day 0 | 22.2 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Malaysia strain, Day 21 | 213.0 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Jiangsu strain, Day 0 | 19.5 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Malaysia strain, Day 0 | 26.6 Titer |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Jiangsu strain, Day 21 | 158.3 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Malaysia strain, Day 0 | 23.2 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Solomon Islands strain, Day 21 | 160.4 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Wisconsin strain, Day 0 | 30.7 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Solomon Islands strain, Day 0 | 23.3 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Malaysia strain, Day 21 | 187.0 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Jiangsu strain, Day 0 | 23.4 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Wisconsin strain, Day 21 | 197.9 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Jiangsu strain, Day 21 | 59.2 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Jiangsu strain, Day 21 | 43.4 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Solomon Islands strain, Day 0 | 18.4 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Wisconsin strain, Day 0 | 29.0 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Wisconsin strain, Day 21 | 156.3 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Malaysia strain, Day 0 | 27.2 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Malaysia strain, Day 21 | 188.5 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | B/Jiangsu strain, Day 0 | 19.2 Titer |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | A/Solomon Islands strain, Day 21 | 133.8 Titer |
Secondary
HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
Time frame: Day 21
Population: Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | FA/Solomon Islands strain | 6.1 Fold increase |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | A/Wisconsin strain | 5.5 Fold increase |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | B/Malaysia strain | 6.0 Fold increase |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | B/Jiangsu strain | 9.1 Fold increase |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | A/Wisconsin strain | 7.4 Fold increase |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | B/Malaysia strain | 8.0 Fold increase |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | B/Jiangsu strain | 8.1 Fold increase |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | FA/Solomon Islands strain | 6.8 Fold increase |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | B/Malaysia strain | 8.1 Fold increase |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | A/Wisconsin strain | 6.4 Fold increase |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | B/Jiangsu strain | 2.5 Fold increase |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | FA/Solomon Islands strain | 6.9 Fold increase |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | B/Jiangsu strain | 2.3 Fold increase |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | A/Wisconsin strain | 5.4 Fold increase |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | FA/Solomon Islands strain | 7.3 Fold increase |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | B/Malaysia strain | 6.9 Fold increase |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).
Time frame: During a 7 day (Days 0-6) follow-up period after vaccination
Population: Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 76 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 3 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 3 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 79 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 6 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 4 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 3 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 5 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 7 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 74 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 2 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 52 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 1 Subjects |
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: During the entire study period (Days 0-180)
Population: Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 1.0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination
Time frame: During a 7-day follow-up period (Days 0-6) after vaccination
Population: Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 4 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 17 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 4 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Nausea | 8 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 33 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Nausea | 8 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Nausea | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 1 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 32 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever | 1 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 25 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 1 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 3 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 6 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 6 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 24 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 17 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 1 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 1 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 47 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 10 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 25 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 3 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 40 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Nausea | 10 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 33 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Nausea | 11 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 36 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 25 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 10 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Nausea | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 47 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 3 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 4 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 3 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever | 3 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 40 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 3 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 13 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 2 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 13 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 36 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 3 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 36 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 28 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 26 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 33 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 33 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Nausea | 8 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Nausea | 2 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Nausea | 8 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 9 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 9 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever | 2 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 2 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 4 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 15 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 23 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 26 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 4 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 33 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 12 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 34 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Nausea | 9 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 15 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 11 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Nausea | 8 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Nausea | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 1 Subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination
Time frame: During a 21 day (Days 0-20) follow-up period after vaccination-
Population: Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | Related unsolicited AE(s) | 3 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | Grade 3 unsolicited AE(s) | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | Any unsolicited AE(s) | 7 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | Grade 3 unsolicited AE(s) | 1 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | Any unsolicited AE(s) | 7 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | Related unsolicited AE(s) | 3 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | Grade 3 unsolicited AE(s) | 3 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | Related unsolicited AE(s) | 7 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | Any unsolicited AE(s) | 16 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | Grade 3 unsolicited AE(s) | 2 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | Any unsolicited AE(s) | 11 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | Related unsolicited AE(s) | 3 Subjects |
Secondary
Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.
Time frame: During the entire study period (Days 0-180)
Population: Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs). | AID | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs). | MAE(s) | 1 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs). | AID | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs). | MAE(s) | 4 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs). | AID | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs). | MAE(s) | 5 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs). | AID | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs). | MAE(s) | 5 Subjects |
Secondary
Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
Time frame: At Day 21
Population: Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | B/Jiangsu strain | 79 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | A/Solomon Islands strain | 59 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | B/Malaysia strain | 60 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | A/Wisconsin strain | 63 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | A/Wisconsin strain | 69 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | B/Jiangsu strain | 82 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | A/Solomon Islands strain | 60 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | B/Malaysia strain | 68 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | A/Solomon Islands strain | 57 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | B/Malaysia strain | 59 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | B/Jiangsu strain | 28 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | A/Wisconsin strain | 67 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | B/Jiangsu strain | 20 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | A/Solomon Islands strain | 63 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | B/Malaysia strain | 62 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | A/Wisconsin strain | 62 Subjects |
Secondary
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
Time frame: At Days 0 and 21
Population: Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Solomon Islands strain, Day 0 | 39 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Solomon Islands strain, Day 21 | 96 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Wisconsin strain, Day 0 | 53 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Wisconsin strain, Day 21 | 101 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Malaysia strain, Day 0 | 53 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Malaysia strain, Day 21 | 101 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Jiangsu strain, Day 0 | 33 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Jiangsu strain, Day 21 | 102 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Malaysia strain, Day 21 | 101 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Malaysia strain, Day 0 | 49 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Solomon Islands strain, Day 21 | 92 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Jiangsu strain, Day 21 | 99 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Jiangsu strain, Day 0 | 40 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Wisconsin strain, Day 21 | 102 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Wisconsin strain, Day 0 | 48 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Solomon Islands strain, Day 0 | 44 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Jiangsu strain, Day 0 | 45 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Wisconsin strain, Day 0 | 56 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Wisconsin strain, Day 21 | 104 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Malaysia strain, Day 0 | 44 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Malaysia strain, Day 21 | 100 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Jiangsu strain, Day 21 | 78 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Solomon Islands strain, Day 0 | 42 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Solomon Islands strain, Day 21 | 97 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Wisconsin strain, Day 0 | 58 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Wisconsin strain, Day 21 | 101 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Solomon Islands strain, Day 21 | 95 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A/Solomon Islands strain, Day 0 | 37 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Malaysia strain, Day 0 | 47 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Jiangsu strain, Day 21 | 67 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Jiangsu strain, Day 0 | 41 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | B/Malaysia strain, Day 21 | 98 Subjects |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
Time frame: During a 7-day follow-up period (Days 0-6) after vaccination
Population: Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Any Pain | 76 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Pain | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Any Redness | 3 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Redness | 1 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Any Swelling | 3 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Swelling | 1 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Swelling | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Redness | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Any Pain | 79 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Any Redness | 6 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Pain | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Any Swelling | 4 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Pain | 3 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Any Redness | 5 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Redness | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Swelling | 3 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Any Swelling | 7 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Any Pain | 74 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Any Swelling | 2 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Swelling | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Pain | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Redness | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Any Pain | 52 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Any Redness | 1 Subjects |
Secondary
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 °C. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature above 39.0°C. . Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Time frame: During a 7-day follow-up period (Days 0-6) after vaccination
Population: Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Fatigue | 32 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Fatigue | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Arthralgia | 6 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Nausea | 8 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Fatigue | 33 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Arthralgia | 6 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Arthralgia | 1 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Nausea | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Nausea | 8 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Myalgia | 17 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Myalgia | 17 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Shivering | 4 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Shivering | 1 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Headache | 24 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Fever | 1 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Fever | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Shivering | 4 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Headache | 3 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Headache | 25 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Fever | 1 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Myalgia | 1 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Fever | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Shivering | 10 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Shivering | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Shivering | 10 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Fever | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Fever | 0 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Arthralgia | 25 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Arthralgia | 3 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Arthralgia | 25 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Fatigue | 47 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Fatigue | 4 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Fatigue | 47 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Headache | 36 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Headache | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Headache | 33 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Myalgia | 40 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Myalgia | 3 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Myalgia | 40 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Nausea | 11 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Nausea | 2 Subjects |
| Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Nausea | 10 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Myalgia | 3 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Nausea | 2 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Shivering | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Shivering | 9 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Myalgia | 33 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Headache | 28 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Shivering | 9 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Nausea | 8 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Arthralgia | 2 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Headache | 26 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Fatigue | 36 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Arthralgia | 13 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Fever | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Arthralgia | 13 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Nausea | 8 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Fatigue | 36 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Myalgia | 33 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Fever | 2 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Headache | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Fatigue | 3 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 1 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Fever | 2 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Fatigue | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Fatigue | 33 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Fever | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Nausea | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Headache | 26 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Headache | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Myalgia | 15 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Headache | 23 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Shivering | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Myalgia | 15 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Nausea | 8 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Myalgia | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Shivering | 4 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Fever | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Arthralgia | 12 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Nausea | 9 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Related Arthralgia | 11 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Fever | 1 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Fatigue | 34 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Grade 3 Arthralgia | 0 Subjects |
| Trivalent Influenza Vaccine GSK 2115160A Group 2 | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Any Shivering | 4 Subjects |