Herpes Zoster
Conditions
Keywords
Boostrix, Herpes zoster, Immunogenicity, Co-administration, Adults, Safety
Brief summary
The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine in adults aged 50 years or older compared to administration of vaccines separately.
Interventions
BIOLOGICALHerpes Zoster vaccine GSK 1437173A
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm at Visit Day 0 and Visit Month 2 for Co-Ad group and at Visit Month 2 and Visit Month 4 for Control group.
BIOLOGICALBoostrix
1 dose administered intramuscularly (IM) in the deltoid region of the dominant arm at Visit Day 0 for both Co-Ad and Control groups.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female aged 50 years or older at the time of the first vaccination with the study vaccine(s). * Written informed consent obtained from the subject. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and 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 vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent). A prednisone dose of \< 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed. * Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine(s) and ending 30 days after the last dose of study vaccine. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines (e.g., inactivated and subunit influenza vaccines). * Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period. * 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 vaccine/product (pharmaceutical product or device). * Previous vaccination against VZV or HZ and/or planned administration during the study of an HZ or VZV vaccine (including an investigational or non-registered vaccine) other than the study vaccine. * History of HZ. * Vaccination against diphtheria, or tetanus in the last five years or planned vaccination against diphtheria or tetanus during the study period, other than the study vaccine(s). * Administration of a combined tetanus, diphtheria and pertussis (Tdap) vaccine at any time prior to study entry. * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus \[HIV\] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines including prior severe allergic reaction following tetanus-toxoid, diphtheria-toxoid or pertussis-containing vaccine. * Hypersensitivity to latex. Note: The investigational HZ/su vaccine does not contain latex. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥ 37.5°C /99.5°F by oral route. The preferred route for recording temperature in this study will be oral. * Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose 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 before 2 months after the last dose of study vaccine. * Any condition which, in the opinion of the investigator, prevents the subject from participating in the study. * Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe. * Encephalopathy (e.g. coma, decreased consciousness, prolonged seizures) not attributable to an identifiable cause within 7 days of administration of a previous pertussis antigen-containing vaccine. * Progressive or unstable neurologic disorder. * History of Arthus-type hypersensitivity reaction following a prior dose of a tetanus-toxoid containing vaccine within the last 10 years. * History of Guillain-Barré syndrome within 6 weeks of receipt of a prior vaccine containing tetanus toxoid.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group | At 1 month post-Dose 2 (Month 3) | This outcome was required only for the GSK1437173A Group. Vaccine response defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. |
| Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens | At 1 month post-Dose 1 (Month 1) | Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). |
| Antibody Concentrations Against Glycoprotein E (Anti-gE) | At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group) | Antibody concentrations against glycoprotein E (gE) have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off was an anti-gE antibody concentration greater than or equal to (≥) 97 mIU/mL. |
| Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens | At 1 month post-Dose 1 (Month 1) | Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (\>) 100 millimeters (mm). 0 Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (\>) 100 millimeters (mm). 0 implies that: 1. No data were applicable for the GSK1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group 2. No data were applicable for the Boostrix vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for both the groups. 3\. No data were applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever \[defined as oral, axillary, rectal or tympanic temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = temperature above (\>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to vaccination. 0 Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses |
| Number of Days With Solicited Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | The number of days with local and general symptoms have been assessed during the solicited post-vaccination period. 0 Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses |
| Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | From first vaccination up to study end (Day 0 to Month 14) | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMDs assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within the 30-day (Days 0-29) post-vaccination period | 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. |
| Number of Subjects With Any Serious Adverse Events (SAEs) | From first vaccination up to study end (Day 0 to Month 14) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
Countries
United States
Participant flow
Recruitment details
Not all subjects who were enrolled started the study due to elimination from statistical analyses or no vaccination received.
Pre-assignment details
For one subject, the reason for withdrawal was incorrectly entered into the eCRF as lost due to Crohn's disease. The subject withdrew from the study due to a combination of irritable bowel syndrome and time constraints associated with employment. This information was clarified after database freeze.
Participants by arm
| Arm | Count |
|---|---|
| GSK1437173A Group Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later. | 412 |
| Control Group Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart. | 418 |
| Total | 830 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Active Phase | Adverse Event | 3 | 2 |
| Active Phase | Enrolled in error | 1 | 0 |
| Active Phase | Lost due to Crohn's disease | 0 | 1 |
| Active Phase | Lost to Follow-up | 8 | 11 |
| Active Phase | Protocol Violation | 1 | 2 |
| Active Phase | Withdrawal by Subject | 3 | 4 |
| Safety Phase | Adverse Event | 6 | 3 |
| Safety Phase | Enrolled in error | 1 | 0 |
| Safety Phase | Lost due to Crohn's disease | 0 | 1 |
| Safety Phase | Lost to Follow-up | 11 | 18 |
| Safety Phase | Protocol Violation | 1 | 2 |
| Safety Phase | Withdrawal by Subject | 8 | 11 |
Baseline characteristics
| Characteristic | GSK1437173A Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 63.4 Years STANDARD_DEVIATION 8.4 | 63.1 Years STANDARD_DEVIATION 9 | 63.25 Years STANDARD_DEVIATION 8.7 |
| Race/Ethnicity, Customized Geographic ancestry African Heritage/African American | 41 Participants | 53 Participants | 94 Participants |
| Race/Ethnicity, Customized Geographic ancestry American Indian or Alaskan Native | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Central/South Asian Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - East Asian Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Japanese Heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Mixed Origin | 2 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Arabic/North African Heritage | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian/European Heritage | 364 Participants | 357 Participants | 721 Participants |
| Sex: Female, Male Female | 222 Participants | 225 Participants | 447 Participants |
| Sex: Female, Male Male | 190 Participants | 193 Participants | 383 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 412 | 5 / 418 |
| other Total, other adverse events | 368 / 412 | 380 / 418 |
| serious Total, serious adverse events | 21 / 412 | 31 / 418 |
Outcome results
Primary
Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens
Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: At 1 month post-Dose 1 (Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A Group | Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens | Anti-D | 2.2 IU/mL |
| GSK1437173A Group | Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens | Anti-T | 8.7 IU/mL |
| Control Group | Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens | Anti-D | 2.5 IU/mL |
| Control Group | Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens | Anti-T | 10.1 IU/mL |
Comparison: Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for diphteria (D) antigen, one month after the vaccine dose.95% CI: [-3.03, 2.85]
Comparison: Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for tetanus (T) antigen, one month after the vaccine dose.95% CI: [-1.18, 1.27]
Primary
Antibody Concentrations Against Glycoprotein E (Anti-gE)
Antibody concentrations against glycoprotein E (gE) have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off was an anti-gE antibody concentration greater than or equal to (≥) 97 mIU/mL.
Time frame: At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK1437173A Group | Antibody Concentrations Against Glycoprotein E (Anti-gE) | 51687.7 mIU/mL |
| Control Group | Antibody Concentrations Against Glycoprotein E (Anti-gE) | 57998.6 mIU/mL |
Comparison: Demonstration of non-inferiority of the humoral immune response to two doses of the GSK1437173A vaccine when Boostrix vaccine was co-administered with the first GSK1437173A vaccine dose compared to two doses of GSK1437173A vaccine (administered separately from Boostrix vaccine), one month after the last vaccine dose.95% CI: [1.02, 1.21]
Primary
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens
Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: At 1 month post-Dose 1 (Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A Group | Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens | Anti-PT | 41.1 IU/mL |
| GSK1437173A Group | Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens | Anti-FHA | 309.3 IU/mL |
| GSK1437173A Group | Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens | Anti-PRN | 222.6 IU/mL |
| Control Group | Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens | Anti-PT | 53.9 IU/mL |
| Control Group | Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens | Anti-FHA | 399.4 IU/mL |
| Control Group | Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens | Anti-PRN | 278.1 IU/mL |
Comparison: Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for pertussis toxoid (PT), one month after the vaccine dose.95% CI: [1, 1.36]
Comparison: Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for filamentous hemagglutinin (FHA) antigen, one month after the vaccine dose.95% CI: [1.07, 1.44]
Comparison: Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for pertactin (PRN) antigen, one month after the vaccine dose.95% CI: [1.02, 1.58]
Primary
Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group
This outcome was required only for the GSK1437173A Group. Vaccine response defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Time frame: At 1 month post-Dose 2 (Month 3)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available, only for subjects in the GSK1437173A Group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group | 361 Participants |
Secondary
Number of Days With Solicited Symptoms
The number of days with local and general symptoms have been assessed during the solicited post-vaccination period. 0 Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| GSK1437173A Group | Number of Days With Solicited Symptoms | Swelling, Dose 1 | 3.3 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Pain, Dose 2 | 2.8 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Redness, Dose 1 | 3.3 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Redness, Dose 2 | 3.2 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Pain, Dose 1 | 3.2 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Swelling, Dose 2 | 3.1 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Fatigue, Dose 1 | 2.4 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Fatigue, Dose 2 | 2.3 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Gastrointestinal, Dose 1 | 2.3 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Gastrointestinal, Dose 2 | 2.0 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Headache, Dose 1 | 1.8 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Headache, Dose 2 | 1.9 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Myalgia, Dose 1 | 2.9 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Myalgia, Dose 2 | 2.7 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Shivering, Dose 1 | 1.6 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Shivering, Dose 2 | 1.6 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Temperature, Dose 1 | 1.7 Days |
| GSK1437173A Group | Number of Days With Solicited Symptoms | Temperature, Dose 2 | 1.6 Days |
| Control Group | Number of Days With Solicited Symptoms | Fatigue, Dose 2 | 2.7 Days |
| Control Group | Number of Days With Solicited Symptoms | Fatigue, Dose 3 | 2.6 Days |
| Control Group | Number of Days With Solicited Symptoms | Temperature, Dose 1 | 2.4 Days |
| Control Group | Number of Days With Solicited Symptoms | Gastrointestinal, Dose 1 | 2.1 Days |
| Control Group | Number of Days With Solicited Symptoms | Shivering, Dose 1 | 2.3 Days |
| Control Group | Number of Days With Solicited Symptoms | Gastrointestinal, Dose 2 | 2.3 Days |
| Control Group | Number of Days With Solicited Symptoms | Gastrointestinal, Dose 3 | 1.9 Days |
| Control Group | Number of Days With Solicited Symptoms | Temperature, Dose 3 | 1.5 Days |
| Control Group | Number of Days With Solicited Symptoms | Headache, Dose 1 | 2.2 Days |
| Control Group | Number of Days With Solicited Symptoms | Shivering, Dose 2 | 1.6 Days |
| Control Group | Number of Days With Solicited Symptoms | Pain, Dose 1 | 2.6 Days |
| Control Group | Number of Days With Solicited Symptoms | Headache, Dose 2 | 2.1 Days |
| Control Group | Number of Days With Solicited Symptoms | Pain, Dose 2 | 2.9 Days |
| Control Group | Number of Days With Solicited Symptoms | Pain, Dose 3 | 2.7 Days |
| Control Group | Number of Days With Solicited Symptoms | Headache, Dose 3 | 2.0 Days |
| Control Group | Number of Days With Solicited Symptoms | Redness, Dose 1 | 3.0 Days |
| Control Group | Number of Days With Solicited Symptoms | Shivering, Dose 3 | 1.5 Days |
| Control Group | Number of Days With Solicited Symptoms | Redness, Dose 2 | 3.2 Days |
| Control Group | Number of Days With Solicited Symptoms | Redness, Dose 3 | 2.9 Days |
| Control Group | Number of Days With Solicited Symptoms | Myalgia, Dose 1 | 2.3 Days |
| Control Group | Number of Days With Solicited Symptoms | Swelling, Dose 1 | 3.5 Days |
| Control Group | Number of Days With Solicited Symptoms | Temperature, Dose 2 | 1.5 Days |
| Control Group | Number of Days With Solicited Symptoms | Swelling, Dose 2 | 3.0 Days |
| Control Group | Number of Days With Solicited Symptoms | Swelling, Dose 3 | 2.9 Days |
| Control Group | Number of Days With Solicited Symptoms | Myalgia, Dose 2 | 2.9 Days |
| Control Group | Number of Days With Solicited Symptoms | Fatigue, Dose 1 | 2.5 Days |
| Control Group | Number of Days With Solicited Symptoms | Myalgia, Dose 3 | 2.7 Days |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (\>) 100 millimeters (mm). 0 Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Dose 1 | 26 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Dose 2 | 289 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Dose 1 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Dose 2 | 15 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Dose 1 | 315 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Dose 2 | 116 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Across doses | 346 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Dose 1 | 79 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Across doses | 39 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Dose 2 | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Across doses | 167 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Dose 1 | 119 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Across doses | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Dose 2 | 83 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Across doses | 124 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Dose 1 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Across doses | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Across doses | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Dose 1 | 156 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Dose 1 | 3 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Dose 1 | 18 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Dose 1 | 22 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Dose 2 | 299 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Dose 2 | 21 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Dose 2 | 102 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Dose 2 | 3 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Dose 2 | 67 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Dose 3 | 282 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Dose 3 | 101 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Dose 3 | 3 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Dose 3 | 76 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Dose 3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Across doses | 357 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Across doses | 39 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Across doses | 148 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Across doses | 7 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Across doses | 115 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Dose 3 | 24 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (\>) 100 millimeters (mm). 0 implies that: 1. No data were applicable for the GSK1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group 2. No data were applicable for the Boostrix vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for both the groups. 3\. No data were applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, Boostrix vaccine, Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, Boostrix vaccine, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, Boostrix vaccine, Dose 2 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, Boostrix vaccine, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, GSK1437173A vaccine, Dose 1 | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, GSK1437173A vaccine, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, Boostrix vaccine, Dose 2 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, GSK1437173A vaccine, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, GSK1437173A vaccine, Dose 1 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, Boostrix vaccine, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, GSK1437173A vaccine, Dose 2 | 116 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, Boostrix vaccine, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, GSK1437173A vaccine, Dose 1 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, GSK1437173A vaccine, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, GSK1437173A vaccine, Dose 2 | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, GSK1437173A vaccine, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, Boostrix vaccine, Dose 1 | 31 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, Boostrix vaccine, Across doses | 183 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, Boostrix vaccine, Dose 2 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, Boostrix vaccine, Across doses | 8 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, Boostrix vaccine, Dose 2 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, GSK1437173A vaccine, Across doses | 339 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, Boostrix vaccine, Dose 2 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, GSK1437173A vaccine, Across doses | 34 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, Boostrix vaccine, Dose 1 | 23 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, Boostrix vaccine, Across doses | 31 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, GSK1437173A vaccine, Dose 2 | 83 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, Boostrix vaccine, Across doses | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, Boostrix vaccine, Dose 2 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, GSK1437173A vaccine, Across doses | 163 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, GSK1437173A vaccine, Dose 2 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, GSK1437173A vaccine, Across doses | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, GSK1437173A vaccine, Dose 1 | 108 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, Boostrix vaccine, Across doses | 23 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, Boostrix vaccine, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, Boostrix vaccine, Across doses | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, GSK1437173A vaccine, Dose 2 | 289 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, GSK1437173A vaccine, Across doses | 117 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, Boostrix vaccine, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, GSK1437173A vaccine,Across doses | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, Boostrix vaccine, Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, Boostrix vaccine, Dose 1 | 183 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, GSK1437173A vaccine, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, Boostrix vaccine, Dose 1 | 8 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, GSK1437173A vaccine, Dose 2 | 15 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, GSK1437173A vaccine, Dose 1 | 290 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, GSK1437173A vaccine, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, GSK1437173A vaccine, Dose 1 | 20 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, Boostrix vaccine, Dose 3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, Boostrix vaccine, Dose 1 | 18 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, Boostrix vaccine, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, GSK1437173A vaccine, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, GSK1437173A vaccine, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, Boostrix vaccine, Dose 1 | 22 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, Boostrix vaccine, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, GSK1437173A vaccine, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, GSK1437173A vaccine, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, Boostrix vaccine, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, Boostrix vaccine, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, GSK1437173A vaccine, Dose 2 | 299 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, GSK1437173A vaccine, Dose 2 | 21 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, Boostrix vaccine, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, Boostrix vaccine, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, GSK1437173A vaccine, Dose 2 | 102 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, GSK1437173A vaccine, Dose 2 | 3 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, Boostrix vaccine, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, Boostrix vaccine, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, GSK1437173A vaccine, Dose 2 | 67 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, GSK1437173A vaccine, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, Boostrix vaccine, Dose 3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, Boostrix vaccine, Dose 3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, GSK1437173A vaccine, Dose 3 | 282 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, GSK1437173A vaccine, Dose 3 | 24 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, Boostrix vaccine, Dose 3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, Boostrix vaccine, Dose 3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, GSK1437173A vaccine, Dose 3 | 101 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, GSK1437173A vaccine, Dose 3 | 3 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, Boostrix vaccine, Dose 3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, GSK1437173A vaccine, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, GSK1437173A vaccine, Dose 3 | 76 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, GSK1437173A vaccine, Dose 3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, Boostrix vaccine, Across doses | 156 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, Boostrix vaccine, Across doses | 3 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, GSK1437173A vaccine, Across doses | 344 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, GSK1437173A vaccine, Across doses | 37 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, Boostrix vaccine, Across doses | 18 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, Boostrix vaccine, Across doses | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Redness, GSK1437173A vaccine, Across doses | 144 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Redness, GSK1437173A vaccine, Across doses | 6 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, Boostrix vaccine, Across doses | 22 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, Boostrix vaccine, Across doses | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Swelling, GSK1437173A vaccine, Across doses | 109 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Swelling, GSK1437173A vaccine,Across doses | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, Boostrix vaccine, Dose 1 | 156 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Grade 3 Pain, Boostrix vaccine, Dose 1 | 3 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Any Pain, GSK1437173A vaccine, Dose 1 | 0 Participants |
Secondary
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMDs assessed by the investigator as causally related to the study vaccination.
Time frame: From first vaccination up to study end (Day 0 to Month 14)
Population: The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Any pIMD(s) | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Related pIMD(s) | 0 Participants |
| Control Group | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Any pIMD(s) | 0 Participants |
| Control Group | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Related pIMD(s) | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose
Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever \[defined as oral, axillary, rectal or tympanic temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = temperature above (\>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to vaccination. 0 Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Gastrointestinal, Dose 1 | 25 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Temperature, Dose 2 | 32 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Fatigue, Dose 2 | 22 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Fatigue, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Myalgia, Dose 1 | 12 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Gastrointestinal, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Fatigue, Dose 2 | 101 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Gastrointestinal, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Gastrointestinal, Dose 1 | 52 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Gastrointestinal, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Gastrointestinal, Dose 2 | 51 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Headache, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Myalgia, Dose 1 | 134 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Headache, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Gastrointestinal, Dose 2 | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Headache, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Headache, Dose 1 | 106 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Myalgia, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Gastrointestinal, Dose 2 | 34 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Myalgia, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Shivering, Dose 1 | 64 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Myalgia, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Headache, Dose 2 | 99 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Shivering, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Fatigue, Dose 1 | 88 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Shivering, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Headache, Dose 2 | 10 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Shivering, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Shivering, Dose 1 | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Temperature, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Headache, Dose 2 | 74 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Temperature, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Headache, Dose 1 | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Shivering, Across doses | 112 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Myalgia, Dose 2 | 160 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Fatigue, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Temperature, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Shivering, Dose 1 | 48 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Fatigue, Across doses | 186 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Myalgia, Dose 2 | 17 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Fatigue, Across doses | 30 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Gastrointestinal, Dose 1 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Fatigue, Across doses | 143 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Myalgia, Dose 2 | 122 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Gastrointestinal, Across doses | 85 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Temperature, Dose 1 | 36 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Gastrointestinal, Across doses | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Shivering, Dose 2 | 79 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Gastrointestinal, Across doses | 51 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Headache, Dose 1 | 74 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Headache, Across doses | 152 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Shivering, Dose 2 | 12 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Headache, Across doses | 16 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Temperature, Dose 1 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Headache, Across doses | 118 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Shivering, Dose 2 | 60 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Myalgia, Across doses | 227 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Fatigue, Dose 1 | 12 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Myalgia, Across doses | 27 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Fatigue, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Myalgia, Across doses | 176 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Temperature, Dose 1 | 26 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Shivering, Across doses | 18 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Myalgia, Dose 1 | 177 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Shivering, Across doses | 86 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Temperature, Dose 2 | 51 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Temperature, Across doses | 72 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Fatigue, Dose 2 | 137 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Temperature, Across doses | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Temperature, Dose 2 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Temperature, Across doses | 48 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Fatigue, Dose 1 | 129 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Temperature, Across doses | 41 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Fatigue, Dose 1 | 65 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Fatigue, Dose 1 | 7 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Fatigue, Dose 1 | 37 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Gastrointestinal, Dose 1 | 35 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Gastrointestinal, Dose 1 | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Gastrointestinal, Dose 1 | 16 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Headache, Dose 1 | 60 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Headache, Dose 1 | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Headache, Dose 1 | 32 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Myalgia, Dose 1 | 102 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Myalgia, Dose 1 | 4 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Myalgia, Dose 1 | 76 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Shivering, Dose 1 | 16 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Shivering, Dose 1 | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Shivering, Dose 1 | 8 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Temperature, Dose 1 | 7 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Temperature, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Temperature, Dose 1 | 5 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Fatigue, Dose 2 | 110 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Fatigue, Dose 2 | 9 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Fatigue, Dose 2 | 74 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Gastrointestinal, Dose 2 | 46 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Gastrointestinal, Dose 2 | 5 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Gastrointestinal, Dose 2 | 28 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Headache, Dose 2 | 82 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Headache, Dose 2 | 8 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Headache, Dose 2 | 54 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Myalgia, Dose 2 | 155 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Myalgia, Dose 2 | 16 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Myalgia, Dose 2 | 116 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Shivering, Dose 2 | 38 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Shivering, Dose 2 | 4 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Shivering, Dose 2 | 27 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Fatigue, Dose 3 | 130 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Temperature, Dose 3 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Temperature, Dose 2 | 23 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Temperature, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Temperature, Dose 2 | 16 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Fatigue, Dose 3 | 92 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Gastrointestinal, Dose 3 | 54 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Gastrointestinal, Dose 3 | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Gastrointestinal, Dose 3 | 37 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Headache, Dose 3 | 95 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Headache, Dose 3 | 8 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Headache, Dose 3 | 69 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Myalgia, Dose 3 | 164 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Myalgia, Dose 3 | 19 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Myalgia, Dose 3 | 124 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Shivering, Dose 3 | 65 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Shivering, Dose 3 | 11 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Shivering, Dose 3 | 50 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Temperature, Dose 3 | 43 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Myalgia, Across doses | 186 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Fatigue, Dose 3 | 14 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Temperature, Dose 3 | 28 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Fatigue, Across doses | 192 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Fatigue, Across doses | 27 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Fatigue, Across doses | 134 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Gastrointestinal, Across doses | 97 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Gastrointestinal, Across doses | 9 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Gastrointestinal, Across doses | 62 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Headache, Across doses | 158 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Headache, Across doses | 15 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Headache, Across doses | 108 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Myalgia, Across doses | 243 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Myalgia, Across doses | 32 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Shivering, Across doses | 100 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Shivering, Across doses | 16 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Related Shivering, Across doses | 72 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Any Temperature, Across doses | 63 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Grade 3 Temperature, Across doses | 1 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: Within the 30-day (Days 0-29) post-vaccination period
Population: The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 105 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 10 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 27 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 118 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 15 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 31 Participants |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs)
Serious adverse events (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 first vaccination up to study end (Day 0 to Month 14)
Population: The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 21 Participants |
| Control Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 31 Participants |