Herpes Zoster
Conditions
Keywords
≥ 50 years of age, Herpes zoster, Safety, Immunogenicity, Adults
Brief summary
The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is not known.
Detailed description
Subjects in each group will be stratified by age with a minimum of 35 subjects in each stratum (50-59 years of age (YOA) stratum, 60-69 YOA stratum and ≥ 70 YOA stratum).
Interventions
BIOLOGICALHerpes zoster vaccine GSK1437173A
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
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. * 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 two months after completion of the vaccination series.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, a prednisone dose of \< 20 mg/day, or equivalent, is allowed. Inhaled, topical and intra-articular corticosteroids are allowed. * Administration or planned administration of a live vaccine in the period starting 30 days before and ending 30 days after either dose of study vaccine. * Administration or planned administration of a non-replicating vaccine within eight days prior to or within 14 days after either dose of study vaccine. * 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. * Previous vaccination against varicella or HZ (either registered product or participation in a previous vaccine study). * Planned administration during the study of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine. * History of HZ. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * 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). * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥ 37.5°C (99.5°F) for oral, axillary or tympanic route, or ≥ 38.0°C (100.4°F) for rectal route. The preferred route for recording temperature in this study will be oral. * Subjects with a minor illness (such as mild diarrhoea, 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 three months preceding the first dose of study vaccine or planned administration during the study period. * Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study. * Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study. * Pregnant or lactating female. * Female planning to become pregnant during the entire treatment period and for two months after completion of the vaccination series, or planning to discontinue contraceptive precautions (if of childbearing potential).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA). | At one month (M1) after Dose 2 | Vaccine response was 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. The objective required a comparison of VRR between 0,6-months and 0,12-months schedules. |
| Concentrations of Antibodies Against Anti-gE as Determined by ELISA. | At one month (M1) after Dose 2 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Solicited General Symptoms. | During the 7 day period (Days 0-6) following each dose (D) | Assessed solicited general symptoms were Fatigue, Gastrointestinal (meaning nausea, vomiting, diarrhoea and/or abdominal pain), Headache, Myalgia, Shivering and Temperature (temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]). Any = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Fatigue = fatigue that prevented normal activity. Grade 3 Gastrointestinal = gastrointestinal that prevented normal every day activities. Grade 3 Headache = headache that prevented normal activity. Grade 3 Myalgia = myalgia that prevented normal activity. Grade 3 Shivering = shivering that prevented normal activity. Grade 3 Temperature = temperature higher than (\>) 39.0°C. |
| Number of Subjects With Unsolicited Adverse Events (AEs). | During the 30 Days (Day 0-29) following vaccination | An adverse event (AE) is 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. |
| Number of Subjects With Serious Adverse Events (SAEs). | From first vaccination up to one month (30 Days) post last vaccination | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. |
| Number of Subjects With SAE(s). | Starting from 30 Days post last vaccine administration up to study end at Month 24 | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. |
| Concentrations of Antibodies Against Anti-gE as Determined by ELISA. | Prior (PRE) to vaccination and twelve (M12) post Dose 2 | — |
| Number of Days With Solicited General Symptoms. | During the 7 Days (Day 0-6) following vaccination | Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2. |
| Number of Subjects With Potential Immune-mediated Diseases (pIMDs). | From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2) | 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. |
| Number of Subjects With pIMDs. | From one month (30 Days) following the last vaccine administration up to study end at Month 24 | 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. |
| Number of Days With Solicited Local Symptoms. | During the 7 Days (Day 0-6) following vaccination | Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2. |
| Number of Subjects With Solicited Local Symptoms. | During the 7 day period (Days 0-6) following each dose (D) | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 100 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity. |
Countries
Estonia, United States
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| GSK1437173A-0,2 M Group Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule. | 119 |
| GSK1437173A-0,6 M Group Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule. | 119 |
| GSK1437173A-0,12 M Group Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule. | 116 |
| Total | 354 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse event, serious fatal | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 |
| Overall Study | Serious adverse event | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | GSK1437173A-0,2 M Group | GSK1437173A-0,6 M Group | GSK1437173A-0,12 M Group | Total |
|---|---|---|---|---|
| Age, Continuous | 64.5 Years STANDARD_DEVIATION 8.9 | 64 Years STANDARD_DEVIATION 8.6 | 64.1 Years STANDARD_DEVIATION 9.2 | 64.2 Years STANDARD_DEVIATION 8.88 |
| Sex: Female, Male Female | 90 Participants | 77 Participants | 79 Participants | 246 Participants |
| Sex: Female, Male Male | 29 Participants | 42 Participants | 37 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 107 / 119 | 106 / 119 | 107 / 116 |
| serious Total, serious adverse events | 5 / 119 | 9 / 119 | 12 / 116 |
Outcome results
Primary
Concentrations of Antibodies Against Anti-gE as Determined by ELISA.
Time frame: At one month (M1) after Dose 2
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects for whom the pre vaccination and one month post dose 2 time point data were obtained from ATP cohort for immunogenicity.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK1437173A-0,6 M Group | Concentrations of Antibodies Against Anti-gE as Determined by ELISA. | 44376.3 mIU/mL |
| GSK1437173A-0,12 M Group | Concentrations of Antibodies Against Anti-gE as Determined by ELISA. | 38153.7 mIU/mL |
| GSK1437173A-0,12 M Group | Concentrations of Antibodies Against Anti-gE as Determined by ELISA. | 37435.8 mIU/mL |
Comparison: To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,6-month schedule compared to a 0,2-month schedule.97.5% CI: [0.98, 1.39]ANCOVA
Comparison: To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,12-month schedule compared to a 0,2-month schedule.97.5% CI: [0.93, 1.53]ANCOVA
Primary
Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA).
Vaccine response was 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. The objective required a comparison of VRR between 0,6-months and 0,12-months schedules.
Time frame: At one month (M1) after Dose 2
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1437173A-0,6 M Group | Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA). | 110 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA). | 104 Subjects |
Secondary
Concentrations of Antibodies Against Anti-gE as Determined by ELISA.
Time frame: Prior (PRE) to vaccination and twelve (M12) post Dose 2
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects for whom the pre vaccination and one month post dose 2 time point data were obtained from ATP cohort for immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A-0,6 M Group | Concentrations of Antibodies Against Anti-gE as Determined by ELISA. | Anti-gE, PRE [N=118,114,110] | 1079.1 mIU/mL |
| GSK1437173A-0,6 M Group | Concentrations of Antibodies Against Anti-gE as Determined by ELISA. | Anti-gE, M12 [N=117,115,110] | 14245.4 mIU/mL |
| GSK1437173A-0,12 M Group | Concentrations of Antibodies Against Anti-gE as Determined by ELISA. | Anti-gE, PRE [N=118,114,110] | 1066.1 mIU/mL |
| GSK1437173A-0,12 M Group | Concentrations of Antibodies Against Anti-gE as Determined by ELISA. | Anti-gE, M12 [N=117,115,110] | 12911.5 mIU/mL |
| GSK1437173A-0,12 M Group | Concentrations of Antibodies Against Anti-gE as Determined by ELISA. | Anti-gE, PRE [N=118,114,110] | 1019.4 mIU/mL |
| GSK1437173A-0,12 M Group | Concentrations of Antibodies Against Anti-gE as Determined by ELISA. | Anti-gE, M12 [N=117,115,110] | 11892.1 mIU/mL |
Secondary
Number of Days With Solicited General Symptoms.
Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.
Time frame: During the 7 Days (Day 0-6) following vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1437173A-0,6 M Group | Number of Days With Solicited General Symptoms. | Days with Headache, D2 | 36 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited General Symptoms. | Days with Temperature, D1 | 21 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited General Symptoms. | Days with Gastrointestinal, D2 | 14 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited General Symptoms. | Days with Shivering, D2 | 25 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited General Symptoms. | Days with Fatigue, D1 | 42 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited General Symptoms. | Days with Gastrointestinal, D1 | 22 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited General Symptoms. | Days with Temperature, D2 | 20 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited General Symptoms. | Days with Myalgia, D1 | 43 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited General Symptoms. | Days with Shivering, D1 | 25 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited General Symptoms. | Days with Headache, D1 | 35 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited General Symptoms. | Days with Myalgia, D2 | 48 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited General Symptoms. | Days with Fatigue, D2 | 43 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Myalgia, D2 | 42 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Shivering, D1 | 25 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Fatigue, D2 | 46 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Shivering, D2 | 23 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Temperature, D1 | 22 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Temperature, D2 | 16 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Gastrointestinal, D1 | 17 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Gastrointestinal, D2 | 5 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Headache, D2 | 27 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Fatigue, D1 | 50 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Myalgia, D1 | 38 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Headache, D1 | 39 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Temperature, D2 | 26 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Headache, D1 | 34 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Fatigue, D1 | 46 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Fatigue, D2 | 59 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Gastrointestinal, D1 | 17 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Gastrointestinal, D2 | 12 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Headache, D2 | 37 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Myalgia, D1 | 46 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Myalgia, D2 | 43 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Shivering, D1 | 29 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Shivering, D2 | 35 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited General Symptoms. | Days with Temperature, D1 | 14 Days |
Secondary
Number of Days With Solicited Local Symptoms.
Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.
Time frame: During the 7 Days (Day 0-6) following vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1437173A-0,6 M Group | Number of Days With Solicited Local Symptoms. | Days with Pain, D1 | 84 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited Local Symptoms. | Days with Swelling, D1 | 17 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited Local Symptoms. | Days with Redness, D1 | 37 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited Local Symptoms. | Days with Redness, D2 | 28 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited Local Symptoms. | Days with Swelling, D2 | 15 Days |
| GSK1437173A-0,6 M Group | Number of Days With Solicited Local Symptoms. | Days with Pain, D2 | 71 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited Local Symptoms. | Days with Redness, D2 | 27 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited Local Symptoms. | Days with Pain, D1 | 77 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited Local Symptoms. | Days with Pain, D2 | 83 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited Local Symptoms. | Days with Redness, D1 | 39 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited Local Symptoms. | Days with Swelling, D1 | 23 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited Local Symptoms. | Days with Swelling, D2 | 9 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited Local Symptoms. | Days with Pain, D2 | 87 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited Local Symptoms. | Days with Swelling, D2 | 24 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited Local Symptoms. | Days with Swelling, D1 | 25 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited Local Symptoms. | Days with Pain, D1 | 80 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited Local Symptoms. | Days with Redness, D1 | 32 Days |
| GSK1437173A-0,12 M Group | Number of Days With Solicited Local Symptoms. | Days with Redness, D2 | 37 Days |
Secondary
Number of Subjects With pIMDs.
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.
Time frame: From one month (30 Days) following the last vaccine administration up to study end at Month 24
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1437173A-0,6 M Group | Number of Subjects With pIMDs. | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With pIMDs. | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With pIMDs. | 0 Subjects |
Secondary
Number of Subjects With Potential Immune-mediated Diseases (pIMDs).
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.
Time frame: From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1437173A-0,6 M Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs). | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs). | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs). | 0 Subjects |
Secondary
Number of Subjects With SAE(s).
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.
Time frame: Starting from 30 Days post last vaccine administration up to study end at Month 24
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1437173A-0,6 M Group | Number of Subjects With SAE(s). | 5 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With SAE(s). | 6 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With SAE(s). | 4 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.
Time frame: From first vaccination up to one month (30 Days) post last vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1437173A-0,6 M Group | Number of Subjects With Serious Adverse Events (SAEs). | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Serious Adverse Events (SAEs). | 4 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Serious Adverse Events (SAEs). | 8 Subjects |
Secondary
Number of Subjects With Solicited General Symptoms.
Assessed solicited general symptoms were Fatigue, Gastrointestinal (meaning nausea, vomiting, diarrhoea and/or abdominal pain), Headache, Myalgia, Shivering and Temperature (temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]). Any = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Fatigue = fatigue that prevented normal activity. Grade 3 Gastrointestinal = gastrointestinal that prevented normal every day activities. Grade 3 Headache = headache that prevented normal activity. Grade 3 Myalgia = myalgia that prevented normal activity. Grade 3 Shivering = shivering that prevented normal activity. Grade 3 Temperature = temperature higher than (\>) 39.0°C.
Time frame: During the 7 day period (Days 0-6) following each dose (D)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Myalgia, Across [N=119,119,116] | 63 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue, D2 [N=118,117,111] | 43 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Headache, Across [N=119,119,116] | 47 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Headache, D1 [N=119,119,115] | 35 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Fatigue, D2 [N=118,117,111] | 4 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Temperature, D1 [N=119,119,115] | 21 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Myalgia, Across [N=119,119,116] | 7 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Fatigue, D2 [N=118,117,111] | 41 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Gastrointestinal, D1 [N=119,119,115] | 3 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue, D1 [N=119,119,115] | 42 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Gastrointestinal, D2 [N=118,117,111] | 14 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Fatigue, Across [N=119,119,116] | 49 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Headache, D1 [N=119,119,115] | 1 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Gastrointestinal, D2 [N=118,117,111] | 0 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Myalgia, Across [N=119,119,116] | 57 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Headache, Across [N=119,119,116] | 2 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Gastrointestinal, D2 [N=118,117,111] | 14 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Gastrointestinal, D1 [N=119,119,115] | 19 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Fatigue, D1 [N=119,119,115] | 37 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Headache, D2 [N=118,117,111] | 36 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Shivering, Across [N=119,119,116] | 37 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Headache, D1 [N=119,119,115] | 31 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Headache, D2 [N=118,117,111] | 2 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Shivering, D1 [N=119,119,115] | 22 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Temperature, D1 [N=119,119,115] | 1 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Headache, D2 [N=118,117,111] | 32 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Shivering, Across [N=119,119,116] | 4 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Headache, Across [N=119,119,116] | 41 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Myalgia, D2 [N=118,117,111] | 48 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Shivering, D1 [N=119,119,115] | 25 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Myalgia, D1 [N=119,119,115] | 43 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Myalgia, D2 [N=118,117,111] | 5 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Shivering, Across [N=119,119,116] | 34 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Gastrointestinal, Across [N=119,119,116] | 27 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Myalgia, D2 [N=118,117,111] | 46 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Temperature, Across [N=119,119,116] | 32 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Shivering, D1 [N=119,119,115] | 1 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Gastrointestinal, Across [N=119,119,116] | 26 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Myalgia, D1 [N=119,119,115] | 2 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Shivering, D2 [N=118,117,111] | 25 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Temperature, D1 [N=119,119,115] | 19 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Temperature, Across [N=119,119,116] | 1 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Shivering, D2 [N=118,117,111] | 3 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue, Across [N=119,119,116] | 54 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Gastrointestinal, D1 [N=119,119,115] | 22 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Shivering, D2 [N=118,117,111] | 24 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Fatigue, D1 [N=119,119,115] | 3 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Myalgia, D1 [N=119,119,115] | 36 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Any Temperature, D2 [N=118,117,111] | 20 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Temperature, Across [N=119,119,116] | 29 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Gastrointestinal, Across [N=119,119,116] | 3 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Temperature, D2 [N=118,117,111] | 0 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Fatigue, Across [N=119,119,116] | 7 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited General Symptoms. | Related Temperature, D2 [N=118,117,111] | 19 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Gastrointestinal, D1 [N=119,119,115] | 17 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Temperature, D2 [N=118,117,111] | 16 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Gastrointestinal, Across [N=119,119,116] | 17 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Shivering, D1 [N=119,119,115] | 25 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue, Across [N=119,119,116] | 63 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Headache, Across [N=119,119,116] | 47 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Gastrointestinal, D1 [N=119,119,115] | 1 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Headache, Across [N=119,119,116] | 4 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Shivering, D1 [N=119,119,115] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Fatigue, Across [N=119,119,116] | 5 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Fatigue, Across [N=119,119,116] | 57 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Headache, Across [N=119,119,116] | 38 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Gastrointestinal, Across [N=119,119,116] | 20 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Shivering, D1 [N=119,119,115] | 22 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Gastrointestinal, Across [N=119,119,116] | 2 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Myalgia, Across [N=119,119,116] | 57 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Myalgia, Across [N=119,119,116] | 4 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Temperature, D1 [N=119,119,115] | 22 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Myalgia, Across [N=119,119,116] | 52 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Shivering, Across [N=119,119,116] | 35 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Shivering, Across [N=119,119,116] | 3 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Temperature, D1 [N=119,119,115] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Gastrointestinal, D1 [N=119,119,115] | 14 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Temperature, Across [N=119,119,116] | 32 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Temperature, Across [N=119,119,116] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Temperature, D1 [N=119,119,115] | 21 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Temperature, Across [N=119,119,116] | 31 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Shivering, Across [N=119,119,116] | 29 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Fatigue, D1 [N=119,119,115] | 1 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue, D2 [N=118,117,111] | 46 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Fatigue, D2 [N=118,117,111] | 4 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Headache, D1 [N=119,119,115] | 39 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Fatigue, D2 [N=118,117,111] | 41 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Gastrointestinal, D2 [N=118,117,111] | 5 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Gastrointestinal, D2 [N=118,117,111] | 1 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Headache, D1 [N=119,119,115] | 1 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Gastrointestinal, D2 [N=118,117,111] | 5 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Headache, D2 [N=118,117,111] | 27 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Headache, D2 [N=118,117,111] | 3 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Headache, D1 [N=119,119,115] | 31 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Headache, D2 [N=118,117,111] | 22 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Fatigue, D1 [N=119,119,115] | 49 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Myalgia, D2 [N=118,117,111] | 42 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Myalgia, D2 [N=118,117,111] | 2 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Myalgia, D1 [N=119,119,115] | 38 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Myalgia, D2 [N=118,117,111] | 39 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue, D1 [N=119,119,115] | 50 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Shivering, D2 [N=118,117,111] | 23 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Myalgia, D1 [N=119,119,115] | 2 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Shivering, D2 [N=118,117,111] | 3 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Shivering, D2 [N=118,117,111] | 20 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Temperature, D2 [N=118,117,111] | 16 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Myalgia, D1 [N=119,119,115] | 33 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Temperature, D2 [N=118,117,111] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Temperature, Across [N=119,119,116] | 30 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue, D1 [N=119,119,115] | 46 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Fatigue, D1 [N=119,119,115] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Fatigue, D1 [N=119,119,115] | 38 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Gastrointestinal, D1 [N=119,119,115] | 17 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Gastrointestinal, D1 [N=119,119,115] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Gastrointestinal, D1 [N=119,119,115] | 12 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Headache, D1 [N=119,119,115] | 34 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Headache, D1 [N=119,119,115] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Headache, D1 [N=119,119,115] | 26 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Myalgia, D1 [N=119,119,115] | 46 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Myalgia, D1 [N=119,119,115] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Myalgia, D1 [N=119,119,115] | 40 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Shivering, D1 [N=119,119,115] | 29 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Shivering, D1 [N=119,119,115] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Shivering, D1 [N=119,119,115] | 26 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Temperature, D1 [N=119,119,115] | 14 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Temperature, D1 [N=119,119,115] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Temperature, D1 [N=119,119,115] | 13 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue, D2 [N=118,117,111] | 59 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Fatigue, D2 [N=118,117,111] | 4 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Fatigue, D2 [N=118,117,111] | 56 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Gastrointestinal, D2 [N=118,117,111] | 12 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Gastrointestinal, D2 [N=118,117,111] | 1 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Gastrointestinal, D2 [N=118,117,111] | 10 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Headache, D2 [N=118,117,111] | 37 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Headache, D2 [N=118,117,111] | 5 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Headache, D2 [N=118,117,111] | 33 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Myalgia, D2 [N=118,117,111] | 43 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Myalgia, D2 [N=118,117,111] | 3 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Gastrointestinal, Across [N=119,119,116] | 1 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Myalgia, D2 [N=118,117,111] | 38 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Shivering, D2 [N=118,117,111] | 35 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Shivering, D2 [N=118,117,111] | 3 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Shivering, D2 [N=118,117,111] | 31 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Temperature, D2 [N=118,117,111] | 26 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Temperature, D2 [N=118,117,111] | 2 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Temperature, D2 [N=118,117,111] | 24 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Gastrointestinal, Across [N=119,119,116] | 21 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Headache, Across [N=119,119,116] | 53 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue, Across [N=119,119,116] | 71 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Headache, Across [N=119,119,116] | 5 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Fatigue, Across [N=119,119,116] | 4 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Fatigue, Across [N=119,119,116] | 65 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Headache, Across [N=119,119,116] | 45 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Gastrointestinal, Across [N=119,119,116] | 27 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Myalgia, Across [N=119,119,116] | 64 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Myalgia, Across [N=119,119,116] | 3 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Myalgia, Across [N=119,119,116] | 57 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Shivering, Across [N=119,119,116] | 48 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Shivering, Across [N=119,119,116] | 3 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Related Shivering, Across [N=119,119,116] | 43 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Any Temperature, Across [N=119,119,116] | 33 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited General Symptoms. | Grade 3 Temperature, Across [N=119,119,116] | 2 Subjects |
Secondary
Number of Subjects With Solicited Local Symptoms.
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 100 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity.
Time frame: During the 7 day period (Days 0-6) following each dose (D)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Pain, D1 [N=119,119,115] | 1 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Redness, D2 [N=118,117,111] | 2 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, D2 [N=118,117,111] | 71 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, D1 [N=119,119,115] | 84 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, D2 [N=118,117,111] | 28 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Pain, D2 [N=118,117,111] | 6 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, Across [N=119,119,116] | 48 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Swelling, Across [N=119,119,116] | 0 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, D1 [N=119,119,115] | 37 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, Across [N=119,119,116] | 26 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Pain, Across [N=119,119,116] | 7 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Redness, D1 [N=119,119,115] | 0 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Across [N=119,119,116] | 91 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Swelling, D2 [N=118,117,111] | 0 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, D1 [N=119,119,115] | 17 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Redness, Across [N=119,119,116] | 2 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, D2 [N=118,117,111] | 15 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Swelling, D1 [N=119,119,115] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Redness, D1 [N=119,119,115] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, D1 [N=119,119,115] | 77 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Pain, D1 [N=119,119,115] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, D1 [N=119,119,115] | 39 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, D1 [N=119,119,115] | 23 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Swelling, D1 [N=119,119,115] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, D2 [N=118,117,111] | 83 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Pain, D2 [N=118,117,111] | 6 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, D2 [N=118,117,111] | 27 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Redness, D2 [N=118,117,111] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, D2 [N=118,117,111] | 9 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Swelling, D2 [N=118,117,111] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Across [N=119,119,116] | 95 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Pain, Across [N=119,119,116] | 6 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, Across [N=119,119,116] | 50 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Redness, Across [N=119,119,116] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, Across [N=119,119,116] | 28 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Swelling, Across [N=119,119,116] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Redness, D1 [N=119,119,115] | 1 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, D1 [N=119,119,115] | 80 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Swelling, D2 [N=118,117,111] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Pain, Across [N=119,119,116] | 12 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Swelling, Across [N=119,119,116] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Across [N=119,119,116] | 98 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, D1 [N=119,119,115] | 32 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Redness, Across [N=119,119,116] | 1 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Pain, D2 [N=118,117,111] | 10 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, D2 [N=118,117,111] | 87 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Pain, D1 [N=119,119,115] | 2 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, D2 [N=118,117,111] | 37 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Swelling, D1 [N=119,119,115] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, Across [N=119,119,116] | 39 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Grade 3 Redness, D2 [N=118,117,111] | 0 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, D1 [N=119,119,115] | 25 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, Across [N=119,119,116] | 53 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, D2 [N=118,117,111] | 24 Subjects |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs).
An adverse event (AE) is 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.
Time frame: During the 30 Days (Day 0-29) following vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1437173A-0,6 M Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Grade 3 AEs | 4 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Any AEs | 27 Subjects |
| GSK1437173A-0,6 M Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Related AEs | 9 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Grade 3 AEs | 4 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Any AEs | 27 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Related AEs | 5 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Any AEs | 23 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Related AEs | 7 Subjects |
| GSK1437173A-0,12 M Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Grade 3 AEs | 4 Subjects |