Influenza
Conditions
Keywords
Adjuvanted pandemic influenza candidate vaccine, Influenza
Brief summary
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.
Detailed description
This study has 2 phases: The study ID 107064 corresponds to objectives & outcome measures evaluated from day 0 until day 51. The study ID 107217 corresponds to objectives & outcome measures evaluated at day 180. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALAdjuvanted pandemic influenza candidate vaccine
2 doses, intramuscular injection
BIOLOGICALFluarix
One intramuscular injection
BIOLOGICALPlacebo
One intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * A male or female aged 18 years or above at the time of the first vaccination. * Written informed consent obtained from the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * If the subject is female, she must be of non-childbearing potential, for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion criteria
* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination. * Administration of interpandemic influenza vaccine between Day 0 and Day 51of the study. Those study participants belonging to risk groups eligible to receive the annual interpandemic influenza vaccine (in accordance with local regulations) can receive the annual vaccination after day 51 and before the end of the study on Day 180. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first administration of the study vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * History of chronic alcohol consumption and/or drug abuse. * History of hypersensitivity to vaccines. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Major congenital defects or serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included). * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the study vaccine or during the study. * Lactating women * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Medically Significant Conditions (MSCs) | From Day 0 to Day 51 | MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of Subjects With New Onset Chronic Diseases (NOCDs) | From Day 0 to Day 180 | NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects With Solicited General Symptoms (Across Doses) | During the 7-day (Days 0-6) post vaccination across dosses | Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (\>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 21st Day (Days 0-20) post Dose 1 | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available. |
| Number of Subjects With AEs | During the 30 Day (Days 0-29) post Dose 2 | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 to Day 180 | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Solicited Local Symptoms | During a 7 day follow-up period after each dose of vaccine and overall. | Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (\>) 50 millimeters (mm) in diameter |
| Number of Subjects With Solicited General Symptoms (Dose 1) | During the 7-day (Days 0-6) after Dose 1 | Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (\>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination. |
| Number of Subjects With Solicited General Symptoms (Dose 2) | During the 7-day (Days 0-6) after Dose 2 | Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (\>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects Against H5N1 | At Day 21 and Day 42 | Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower 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 fourfold increase in post-vaccination titer. Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination. |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain | At Day 21 and Day 42 | Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0. |
| Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | At Day 0 (PRE), Day 21 and Day 42 | Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection. |
| Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | At Day 0 (PRE), 21 and 42 | Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs). |
Countries
Estonia, France, Germany, Netherlands, Russia, Spain, Sweden
Participant flow
Pre-assignment details
Out of the 5075 subjects enrolled in this study, 4 subjects did not receive any study vaccine and were hence excluded from study start.
Participants by arm
| Arm | Count |
|---|---|
| GSK1562902A 18-60 YOA Group Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. | 3,397 |
| GSK1562902A >60 YOA Group Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. | 405 |
| Fluarix+Placebo 18-60 YOA Group Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. | 1,136 |
| Fluarix+Placebo >60 YOA Group Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. | 133 |
| Total | 5,071 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 20 | 1 |
| Overall Study | Lost to Follow-up | 37 | 13 |
| Overall Study | Migrated/moved from study area | 2 | 1 |
| Overall Study | Others | 33 | 8 |
| Overall Study | Protocol Violation | 3 | 1 |
| Overall Study | Serious adverse event | 3 | 0 |
| Overall Study | Withdrawal by Subject | 37 | 8 |
Baseline characteristics
| Characteristic | GSK1562902A 18-60 YOA Group | GSK1562902A >60 YOA Group | Fluarix+Placebo 18-60 YOA Group | Fluarix+Placebo >60 YOA Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 34.8 Years STANDARD_DEVIATION 12.24 | 67.3 Years STANDARD_DEVIATION 6.01 | 35.4 Years STANDARD_DEVIATION 12.51 | 66.6 Years STANDARD_DEVIATION 5.2 | 38.36 Years STANDARD_DEVIATION 15.4 |
| Sex: Female, Male Female | 2018 Participants | 187 Participants | 691 Participants | 56 Participants | 2952 Participants |
| Sex: Female, Male Male | 1379 Participants | 218 Participants | 445 Participants | 77 Participants | 2119 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 | 3,189 / 3,397 | 338 / 405 | 938 / 1,136 | 83 / 133 |
| serious Total, serious adverse events | 27 / 3,397 | 15 / 405 | 10 / 1,136 | 5 / 133 |
Outcome results
Primary
Number of Subjects With AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.
Time frame: During the 30 Day (Days 0-29) post Dose 2
Population: The analysis was performed on the TVc which included all subjects who had received the second dose and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 18-60 YOA Group | Number of Subjects With AEs | Any AEs | 644 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With AEs | Grade 3 AEs | 65 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With AEs | Grade 3 AEs | 9 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With AEs | Any AEs | 75 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With AEs | Any AEs | 180 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With AEs | Grade 3 AEs | 28 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With AEs | Any AEs | 23 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With AEs | Grade 3 AEs | 3 Participants |
Primary
Number of Subjects With Medically Significant Conditions (MSCs)
MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: From Day 0 to Day 51
Population: The analysis was performed on the TVc which included all vaccinated subjects for whom data were available at Day 51.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A 18-60 YOA Group | Number of Subjects With Medically Significant Conditions (MSCs) | 60 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Medically Significant Conditions (MSCs) | 10 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Medically Significant Conditions (MSCs) | 11 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Medically Significant Conditions (MSCs) | 3 Participants |
Primary
Number of Subjects With New Onset Chronic Diseases (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From Day 0 to Day 180
Population: The analysis was performed on the Vaccinated Cohort (Extended follow-up) which included all vaccinated subjects for whom data were available at Day 180.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A 18-60 YOA Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 9 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 7 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 3 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 0 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 to Day 180
Population: The analysis was performed on the Vaccinated Cohort (Extended follow-up) which included all vaccinated subjects for whom data were available at Day 180.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A 18-60 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | 27 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | 15 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | 10 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | 5 Participants |
Primary
Number of Subjects With Solicited General Symptoms (Across Doses)
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (\>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Time frame: During the 7-day (Days 0-6) post vaccination across dosses
Population: The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Arthralgia, Across | 874 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Arthralgia, Across | 87 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Arthralgia, Across | 829 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Fatigue, Across | 1736 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Fatigue, Across | 155 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Fatigue, Across | 1576 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Fever, Across | 466 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Fever, Across | 16 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Fever, Across | 432 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Headache, Across | 1566 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Headache, Across | 112 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Headache, Across | 1347 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Myalgia, Across | 1670 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Myalgia, Across | 125 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Myalgia, Across | 1593 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Shivering, Across | 711 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Shivering, Across | 56 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Shivering, Across | 675 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Sweating, Across | 727 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Sweating, Across | 47 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Sweating, Across | 649 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Shivering, Across | 21 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Arthralgia, Across | 82 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Fever, Across | 1 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Headache, Across | 94 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Fever, Across | 24 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Shivering, Across | 26 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Myalgia, Across | 107 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Myalgia, Across | 124 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Arthralgia, Across | 67 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Sweating, Across | 9 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Shivering, Across | 1 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Myalgia, Across | 5 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Fever, Across | 20 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Fatigue, Across | 4 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Fatigue, Across | 100 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Sweating, Across | 53 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Headache, Across | 114 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Fatigue, Across | 117 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Arthralgia, Across | 4 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Sweating, Across | 64 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Headache, Across | 3 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Arthralgia, Across | 4 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Fatigue, Across | 289 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Fever, Across | 38 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Shivering, Across | 71 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Fever, Across | 0 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Fever, Across | 29 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Headache, Across | 350 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Headache, Across | 14 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Sweating, Across | 134 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Headache, Across | 266 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Myalgia, Across | 276 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Sweating, Across | 102 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Myalgia, Across | 9 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Myalgia, Across | 249 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Sweating, Across | 3 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Shivering, Across | 86 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Arthralgia, Across | 130 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Arthralgia, Across | 112 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Shivering, Across | 2 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Fatigue, Across | 346 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Fatigue, Across | 8 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Shivering, Across | 5 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Headache, Across | 2 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Shivering, Across | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Arthralgia, Across | 15 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Sweating, Across | 2 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Headache, Across | 19 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Fever, Across | 7 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Arthralgia, Across | 1 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Shivering, Across | 5 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Fever, Across | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Fatigue, Across | 17 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Arthralgia, Across | 13 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Sweating, Across | 16 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Myalgia, Across | 2 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Myalgia, Across | 18 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Sweating, Across | 19 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Fever, Across | 9 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Myalgia, Across | 14 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Grade 3 Fatigue, Across | 3 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Related Headache, Across | 16 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Across Doses) | Any Fatigue, Across | 24 Participants |
Primary
Number of Subjects With Solicited General Symptoms (Dose 1)
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (\>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Time frame: During the 7-day (Days 0-6) after Dose 1
Population: The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Arthralgia, Dose 1 | 625 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Arthralgia, Dose 1 | 47 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Arthralgia, Dose 1 | 583 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Fatigue, Dose 1 | 1384 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Fatigue, Dose 1 | 90 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Fatigue, Dose 1 | 1220 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Fever, Dose 1 | 270 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Fever, Dose 1 | 7 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Fever, Dose 1 | 243 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Headache, Dose 1 | 1159 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Headache, Dose 1 | 60 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Headache, Dose 1 | 960 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Myalgia, Dose 1 | 1336 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Myalgia, Dose 1 | 77 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Myalgia, Dose 1 | 1249 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Shivering, Dose 1 | 482 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Shivering, Dose 1 | 34 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Shivering, Dose 1 | 448 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Sweating, Dose 1 | 481 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Sweating, Dose 1 | 17 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Sweating, Dose 1 | 415 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Shivering, Dose 1 | 11 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Arthralgia, Dose 1 | 57 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Fever, Dose 1 | 0 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Headache, Dose 1 | 63 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Fever, Dose 1 | 10 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Shivering, Dose 1 | 14 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Myalgia, Dose 1 | 80 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Myalgia, Dose 1 | 93 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Arthralgia, Dose 1 | 46 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Sweating, Dose 1 | 3 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Myalgia, Dose 1 | 1 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Fever, Dose 1 | 8 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Fatigue, Dose 1 | 3 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Fatigue, Dose 1 | 67 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Sweating, Dose 1 | 31 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Headache, Dose 1 | 79 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Fatigue, Dose 1 | 80 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Arthralgia, Dose 1 | 1 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Sweating, Dose 1 | 38 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Headache, Dose 1 | 1 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Arthralgia, Dose 1 | 3 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Fatigue, Dose 1 | 235 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Fever, Dose 1 | 24 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Shivering, Dose 1 | 55 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Fever, Dose 1 | 0 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Fever, Dose 1 | 20 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Headache, Dose 1 | 275 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Headache, Dose 1 | 6 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Sweating, Dose 1 | 95 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Headache, Dose 1 | 203 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Myalgia, Dose 1 | 239 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Sweating, Dose 1 | 71 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Myalgia, Dose 1 | 5 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Myalgia, Dose 1 | 220 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Sweating, Dose 1 | 1 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Shivering, Dose 1 | 67 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Arthralgia, Dose 1 | 100 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Arthralgia, Dose 1 | 86 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Shivering, Dose 1 | 2 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Fatigue, Dose 1 | 284 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Fatigue, Dose 1 | 4 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Shivering, Dose 1 | 3 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Headache, Dose 1 | 2 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Shivering, Dose 1 | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Arthralgia, Dose 1 | 13 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Sweating, Dose 1 | 1 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Headache, Dose 1 | 18 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Fever, Dose 1 | 5 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Arthralgia, Dose 1 | 1 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Shivering, Dose 1 | 3 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Fever, Dose 1 | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Fatigue, Dose 1 | 15 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Arthralgia, Dose 1 | 11 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Sweating, Dose 1 | 15 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Myalgia, Dose 1 | 2 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Myalgia, Dose 1 | 12 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Sweating, Dose 1 | 17 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Fever, Dose 1 | 6 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Myalgia, Dose 1 | 11 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Grade 3 Fatigue, Dose 1 | 2 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Related Headache, Dose 1 | 15 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 1) | Any Fatigue, Dose 1 | 20 Participants |
Primary
Number of Subjects With Solicited General Symptoms (Dose 2)
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (\>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Time frame: During the 7-day (Days 0-6) after Dose 2
Population: The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Arthralgia, Dose 2 | 513 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Arthralgia, Dose 2 | 46 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Arthralgia, Dose 2 | 493 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Fatigue, Dose 2 | 1108 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Fatigue, Dose 2 | 81 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Fatigue, Dose 2 | 1014 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Fever, Dose 2 | 278 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Fever, Dose 2 | 10 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Fever, Dose 2 | 266 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Headache, Dose 2 | 934 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Headache, Dose 2 | 59 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Headache, Dose 2 | 800 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Myalgia, Dose 2 | 1044 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Myalgia, Dose 2 | 61 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Myalgia, Dose 2 | 999 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Shivering, Dose 2 | 390 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Shivering, Dose 2 | 29 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Shivering, Dose 2 | 378 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Sweating, Dose 2 | 442 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Sweating, Dose 2 | 32 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Sweating, Dose 2 | 397 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Shivering, Dose 2 | 13 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Arthralgia, Dose 2 | 47 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Fever, Dose 2 | 1 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Headache, Dose 2 | 56 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Fever, Dose 2 | 16 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Shivering, Dose 2 | 15 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Myalgia, Dose 2 | 65 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Myalgia, Dose 2 | 72 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Arthralgia, Dose 2 | 39 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Sweating, Dose 2 | 7 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Shivering, Dose 2 | 1 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Myalgia, Dose 2 | 4 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Fever, Dose 2 | 14 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Fatigue, Dose 2 | 2 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Fatigue, Dose 2 | 66 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Sweating, Dose 2 | 33 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Headache, Dose 2 | 69 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Fatigue, Dose 2 | 77 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Arthralgia, Dose 2 | 3 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Sweating, Dose 2 | 41 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Headache, Dose 2 | 2 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Arthralgia, Dose 2 | 2 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Fatigue, Dose 2 | 119 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Fever, Dose 2 | 15 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Shivering, Dose 2 | 19 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Fever, Dose 2 | 0 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Fever, Dose 2 | 10 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Headache, Dose 2 | 155 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Headache, Dose 2 | 8 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Sweating, Dose 2 | 59 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Headache, Dose 2 | 111 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Myalgia, Dose 2 | 67 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Sweating, Dose 2 | 42 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Myalgia, Dose 2 | 5 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Myalgia, Dose 2 | 53 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Sweating, Dose 2 | 2 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Shivering, Dose 2 | 24 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Arthralgia, Dose 2 | 41 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Arthralgia, Dose 2 | 34 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Shivering, Dose 2 | 0 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Fatigue, Dose 2 | 148 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Fatigue, Dose 2 | 5 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Shivering, Dose 2 | 5 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Headache, Dose 2 | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Shivering, Dose 2 | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Arthralgia, Dose 2 | 6 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Sweating, Dose 2 | 1 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Headache, Dose 2 | 8 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Fever, Dose 2 | 4 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Arthralgia, Dose 2 | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Shivering, Dose 2 | 5 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Fever, Dose 2 | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Fatigue, Dose 2 | 12 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Arthralgia, Dose 2 | 4 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Sweating, Dose 2 | 9 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Myalgia, Dose 2 | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Myalgia, Dose 2 | 10 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Sweating, Dose 2 | 13 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Fever, Dose 2 | 5 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Myalgia, Dose 2 | 7 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Grade 3 Fatigue, Dose 2 | 1 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Related Headache, Dose 2 | 8 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited General Symptoms (Dose 2) | Any Fatigue, Dose 2 | 14 Participants |
Primary
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (\>) 50 millimeters (mm) in diameter
Time frame: During a 7 day follow-up period after each dose of vaccine and overall.
Population: The analysis was performed on the Total Vaccinated cohort (TVc) which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Ecchymosis, Dose 2 [N=3247;395;1102;132] | 3 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 [N=3247;395;1102;132] | 77 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across [N=3343;1123;133] | 1107 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 [N=3247;395;1102;132] | 819 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Ecchymosis, Across [N=3343;403;1123;133] | 11 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 [N=3247;395;1102;132] | 168 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1[N=3342;403;1123;133] | 2926 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 [N=3247;395;1102.132] | 719 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Ecchymosis, Across [N=3343;403;1123;133] | 320 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 [N=3247;395;1102;132] | 96 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across [N=3343;403;1123;133] | 250 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1[N=3342;403;1123;133] | 169 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Ecchymosis, Dose 1[N=3342;403;1123;133] | 8 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1[N=3342;403;1123;133] | 910 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across [N=3343;403;1123;133] | 1277 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1[N=3342;403;1123;133] | 128 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1[N=3342;403;1123;133] | 812 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across [N=3343;1123;133] | 189 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across [N=3343;403;1123;133] | 221 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1[N=3342;403;1123;133] | 134 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Induration, Dose 1[N=3342;403;1123;133] | 876 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Ecchymosis, Dose 2 [N=3247;395;1102;132] | 144 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across [N=3343;403;1123;133] | 3037 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Induration, Across [N=3343;403;1123;133] | 1150 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Ecchymosis, Dose 1 [N=3342;403;1123;133] | 212 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Induration, Dose 2 [N=3247;395;1102;132] | 734 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Induration, Across [N=3343;403;1123;133] | 148 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Induration, Dose 2 [N=3247;395;1102;132] | 81 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Induration, Dose 1[N=3342;403;1123;133] | 96 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 [N=3247;395;1102;132] | 2451 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1[N=3342;403;1123;133] | 12 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Ecchymosis, Dose 1 [N=3342;403;1123;133] | 16 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 [N=3247;395;1102;132] | 1 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across [N=3343;403;1123;133] | 4 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Ecchymosis, Across [N=3343;403;1123;133] | 2 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Ecchymosis, Dose 2 [N=3247;395;1102;132] | 1 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 [N=3247;395;1102;132] | 105 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across [N=3343;403;1123;133] | 36 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1[N=3342;403;1123;133] | 88 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Induration, Dose 2 [N=3247;395;1102;132] | 7 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 [N=3247;395;1102;132] | 25 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Induration, Across [N=3343;403;1123;133] | 12 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Ecchymosis, Across [N=3343;403;1123;133] | 29 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 [N=3247;395;1102;132] | 199 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 [N=3247;395;1102.132] | 89 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1[N=3342;403;1123;133] | 233 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1[N=3342;403;1123;133] | 12 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Induration, Dose 2 [N=3247;395;1102;132] | 75 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 [N=3247;395;1102;132] | 11 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across [N=3343;1123;133] | 22 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across [N=3343;403;1123;133] | 271 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across [N=3343;1123;133] | 133 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1[N=3342;403;1123;133] | 3 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Ecchymosis, Dose 2 [N=3247;395;1102;132] | 16 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across [N=3343;403;1123;133] | 165 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Induration, Dose 1[N=3342;403;1123;133] | 73 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1[N=3342;403;1123;133] | 112 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Ecchymosis, Dose 1[N=3342;403;1123;133] | 1 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Induration, Across [N=3343;403;1123;133] | 108 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Induration, Dose 1[N=3342;403;1123;133] | 6 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Induration, Dose 1[N=3342;403;1123;133] | 10 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Ecchymosis, Dose 1 [N=3342;403;1123;133] | 39 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Ecchymosis, Dose 1[N=3342;403;1123;133] | 0 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Induration, Dose 1[N=3342;403;1123;133] | 199 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1[N=3342;403;1123;133] | 724 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1[N=3342;403;1123;133] | 6 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1[N=3342;403;1123;133] | 281 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1[N=3342;403;1123;133] | 17 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1[N=3342;403;1123;133] | 176 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1[N=3342;403;1123;133] | 12 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Ecchymosis, Dose 2 [N=3247;395;1102;132] | 31 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Ecchymosis, Dose 2 [N=3247;395;1102;132] | 1 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Induration, Dose 2 [N=3247;395;1102;132] | 41 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Induration, Dose 2 [N=3247;395;1102;132] | 0 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 [N=3247;395;1102;132] | 173 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 [N=3247;395;1102;132] | 2 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 [N=3247;395;1102;132] | 93 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 [N=3247;395;1102;132] | 1 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 [N=3247;395;1102.132] | 42 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 [N=3247;395;1102;132] | 0 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Ecchymosis, Across [N=3343;403;1123;133] | 65 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Ecchymosis, Across [N=3343;403;1123;133] | 1 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Induration, Across [N=3343;403;1123;133] | 215 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Induration, Across [N=3343;403;1123;133] | 10 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across [N=3343;403;1123;133] | 748 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across [N=3343;403;1123;133] | 8 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across [N=3343;403;1123;133] | 312 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across [N=3343;403;1123;133] | 17 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across [N=3343;1123;133] | 196 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across [N=3343;1123;133] | 12 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Induration, Dose 2 [N=3247;395;1102;132] | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across [N=3343;403;1123;133] | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Induration, Across [N=3343;403;1123;133] | 19 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Induration, Dose 2 [N=3247;395;1102;132] | 5 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Ecchymosis, Dose 2 [N=3247;395;1102;132] | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across [N=3343;1123;133] | 17 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Induration, Across [N=3343;403;1123;133] | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Ecchymosis, Dose 2 [N=3247;395;1102;132] | 3 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1[N=3342;403;1123;133] | 1 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Induration, Dose 1[N=3342;403;1123;133] | 17 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across [N=3343;403;1123;133] | 39 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1[N=3342;403;1123;133] | 15 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1[N=3342;403;1123;133] | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across [N=3343;1123;133] | 1 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across [N=3343;403;1123;133] | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1[N=3342;403;1123;133] | 34 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1[N=3342;403;1123;133] | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Ecchymosis, Dose 1[N=3342;403;1123;133] | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across [N=3343;403;1123;133] | 38 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1[N=3342;403;1123;133] | 36 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 [N=3247;395;1102;132] | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 [N=3247;395;1102.132] | 4 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 [N=3247;395;1102;132] | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Induration, Dose 1[N=3342;403;1123;133] | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Ecchymosis, Across [N=3343;403;1123;133] | 5 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 [N=3247;395;1102;132] | 16 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 [N=3247;395;1102;132] | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Ecchymosis, Dose 1 [N=3342;403;1123;133] | 3 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Ecchymosis, Across [N=3343;403;1123;133] | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 [N=3247;395;1102;132] | 8 Participants |
Primary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.
Time frame: During the 21st Day (Days 0-20) post Dose 1
Population: The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in at Day 51.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 18-60 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 917 Participants |
| GSK1562902A 18-60 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 95 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 5 Participants |
| GSK1562902A >60 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 74 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 244 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 22 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 19 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 1 Participants |
Secondary
Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1
Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).
Time frame: At Day 0 (PRE), 21 and 42
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 18-60 YOA Group | Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | anti-HA, Day 42 [N=268;140;96;50] | 307.0 Titers |
| GSK1562902A 18-60 YOA Group | Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | anti-HA, Pre [N=269;146;96;50] | 5.0 Titers |
| GSK1562902A 18-60 YOA Group | Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | anti-HA, Day 21 [N=269;145;97;49] | 31.8 Titers |
| GSK1562902A >60 YOA Group | Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | anti-HA, Day 21 [N=269;145;97;49] | 43.8 Titers |
| GSK1562902A >60 YOA Group | Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | anti-HA, Pre [N=269;146;96;50] | 5.0 Titers |
| GSK1562902A >60 YOA Group | Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | anti-HA, Day 42 [N=268;140;96;50] | 187.0 Titers |
| Fluarix+Placebo 18-60 YOA Group | Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | anti-HA, Day 21 [N=269;145;97;49] | 6.0 Titers |
| Fluarix+Placebo 18-60 YOA Group | Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | anti-HA, Pre [N=269;146;96;50] | 5.0 Titers |
| Fluarix+Placebo 18-60 YOA Group | Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | anti-HA, Day 42 [N=268;140;96;50] | 5.6 Titers |
| Fluarix+Placebo >60 YOA Group | Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | anti-HA, Pre [N=269;146;96;50] | 5.0 Titers |
| Fluarix+Placebo >60 YOA Group | Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | anti-HA, Day 42 [N=268;140;96;50] | 7.5 Titers |
| Fluarix+Placebo >60 YOA Group | Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | anti-HA, Day 21 [N=269;145;97;49] | 7.5 Titers |
Secondary
Number of Seroconverted Subjects Against H5N1
Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower 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 fourfold increase in post-vaccination titer. Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.
Time frame: At Day 21 and Day 42
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 18-60 YOA Group | Number of Seroconverted Subjects Against H5N1 | anti-HA, Day 21 [N=269;145;96;49] | 147 Participants |
| GSK1562902A 18-60 YOA Group | Number of Seroconverted Subjects Against H5N1 | anti-HA, Day 42 [N=268;140;96;50] | 245 Participants |
| GSK1562902A >60 YOA Group | Number of Seroconverted Subjects Against H5N1 | anti-HA, Day 42 [N=268;140;96;50] | 128 Participants |
| GSK1562902A >60 YOA Group | Number of Seroconverted Subjects Against H5N1 | anti-HA, Day 21 [N=269;145;96;49] | 89 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Seroconverted Subjects Against H5N1 | anti-HA, Day 21 [N=269;145;96;49] | 5 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Seroconverted Subjects Against H5N1 | anti-HA, Day 42 [N=268;140;96;50] | 3 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Seroconverted Subjects Against H5N1 | anti-HA, Day 21 [N=269;145;96;49] | 5 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Seroconverted Subjects Against H5N1 | anti-HA, Day 42 [N=268;140;96;50] | 6 Participants |
Secondary
Number of Seroprotected Subjects Against A/Vietnam Influenza Strain
Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection.
Time frame: At Day 0 (PRE), Day 21 and Day 42
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 18-60 YOA Group | Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | A/Vietnam, Day 42 [N=268;140;96;50] | 245 Participants |
| GSK1562902A 18-60 YOA Group | Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | A/Vietnam, PRE [N=269;146;96;50] | 0 Participants |
| GSK1562902A 18-60 YOA Group | Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | A/Vietnam, Day 21 [N=269;145;97;49] | 147 Participants |
| GSK1562902A >60 YOA Group | Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | A/Vietnam, Day 42 [N=268;140;96;50] | 128 Participants |
| GSK1562902A >60 YOA Group | Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | A/Vietnam, Day 21 [N=269;145;97;49] | 89 Participants |
| GSK1562902A >60 YOA Group | Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | A/Vietnam, PRE [N=269;146;96;50] | 0 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | A/Vietnam, PRE [N=269;146;96;50] | 0 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | A/Vietnam, Day 21 [N=269;145;97;49] | 5 Participants |
| Fluarix+Placebo 18-60 YOA Group | Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | A/Vietnam, Day 42 [N=268;140;96;50] | 3 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | A/Vietnam, Day 42 [N=268;140;96;50] | 6 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | A/Vietnam, PRE [N=269;146;96;50] | 0 Participants |
| Fluarix+Placebo >60 YOA Group | Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | A/Vietnam, Day 21 [N=269;145;97;49] | 5 Participants |
Secondary
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0.
Time frame: At Day 21 and Day 42
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 18-60 YOA Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain | A/Vietnam, Day 21 [N=269;145;96;49] | 6.4 Titer fold increase |
| GSK1562902A 18-60 YOA Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain | A/Vietnam, Day 21 [N=268;140;96;50] | 61.4 Titer fold increase |
| GSK1562902A >60 YOA Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain | A/Vietnam, Day 21 [N=268;140;96;50] | 37.4 Titer fold increase |
| GSK1562902A >60 YOA Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain | A/Vietnam, Day 21 [N=269;145;96;49] | 8.8 Titer fold increase |
| Fluarix+Placebo 18-60 YOA Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain | A/Vietnam, Day 21 [N=269;145;96;49] | 1.2 Titer fold increase |
| Fluarix+Placebo 18-60 YOA Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain | A/Vietnam, Day 21 [N=268;140;96;50] | 1.1 Titer fold increase |
| Fluarix+Placebo >60 YOA Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain | A/Vietnam, Day 21 [N=269;145;96;49] | 1.5 Titer fold increase |
| Fluarix+Placebo >60 YOA Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain | A/Vietnam, Day 21 [N=268;140;96;50] | 1.5 Titer fold increase |