Herpes Zoster
Conditions
Keywords
Herpes Zoster, Intramuscular, Subcutaneous, Safety, ≥50 years of age, Adults, Immunogenicity, Elderly
Brief summary
The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC) as compared to intramuscularly (IM) to people 50 years of age and older.
Detailed description
There are 2 treatment groups in this study based upon the mode of vaccine administration. The humoral immunogenicity (HI) will be measured in all subjects.
Interventions
BIOLOGICALHerpes zoster vaccine GSK1437173A
HZ/su vaccine administered either into the subcutaneous tissue of the upper arm (deltoid region) of the non-dominant arm or intramuscularly in the deltoid region of non-dominant arm on a 0,2-month schedule.
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
* Subject who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Subject, residing in Japan, is of Japanese ethnic origin, defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese. * Subject has provided written informed consent. * Subject, male or female, who is 50 YOA or older at the time of the first vaccination. * Subject, if female, of non-childbearing potential may be enrolled in the study. * Subject, if female, 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 (i.e., for 2 months after Month 2). *
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Concurrently participating or planned participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Administration or planned administration of a live vaccine within 30 days prior to the first study vaccination through 30 days after the second study vaccination. * Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine. * Planned administration, during the study, of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine. * Administration of immunoglobulins and/or any blood products within the three (3) months preceding the first dose of study vaccine or planned administration during the study period. * Chronic administration (defined as \>14 consecutive days) 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 long-acting immune-modifying drugs (e.g., infliximab) within six months prior to the first vaccine dose through the duration of the study period. * History of HZ. * Previous vaccination against HZ or varicella (registered or investigational product). * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment. * 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. * Acute disease and/or fever at the time of vaccination: * 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. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) through Month 4 (i.e., 2 months after the second dose of study vaccine).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | From Month 0 to Month 3 | 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. |
| Number of Subjects With Solicited Local Symptoms | During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses | The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities. |
| Number of Subjects With Solicited General Symptoms | During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses | Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature higher than (\>) 39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination. |
| Mean Number of Days With General Symptoms | During the 7 day (Days 0-6) post vaccination, after each dose (D) | Days with solicited general symptoms were tabulated for the total vaccinated cohort. |
| Number of Subjects With Potential Immune-Mediated Disorders (pIMDs) | From Month 0 to Month 3 | Potential immune-mediated diseases (pIMDs) were 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 Unsolicited Adverse Events (AEs) | Within 30 days (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. |
| Mean Number of Days With Local Symptoms | During the 7 day (Days 0-6) post vaccination, after each dose (D) | Days with solicited local symptoms were tabulated for the total vaccinated cohort. |
| Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL) | Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3) | A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value, of 18 mIU/mL. |
| Anti-gE Antibody Concentrations | Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3) | Anti-gE antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL. |
| Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations | At two months after Dose 1 (M2) and one month after Dose 2 (M3) | Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. |
| Descriptive Statistics of Anti-gE Antibody Concentrations | Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3) | Anti-gE antibody concentrations were assessed by the Enzyme Lynked Immunosorbent Assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-gE Antibody Concentrations | At Month 14 | Anti-gE antibody concentrations were expressed as geometric mean concnetrations (GMCs) and measured in mIU/mL. |
| Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations | Twelve Months after Dose 2 (M14) | 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. |
| Number of Subjects With pIMDs | Up to Month 14 post vaccination period | Potential immune-mediated diseases (pIMDs) were 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 SAEs | Up to Month 14 post vaccination period | 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. |
| Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL | At Month 14 | A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value of 97 mIU/mL. |
Countries
Japan
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 |
|---|---|
| SC GSK1437173A Group Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule. | 30 |
| IM GSK1437173A Group Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | SC GSK1437173A Group | IM GSK1437173A Group | Total |
|---|---|---|---|
| Age, Continuous | 61.6 Years STANDARD_DEVIATION 7.59 | 62.2 Years STANDARD_DEVIATION 7.83 | 61.90 Years STANDARD_DEVIATION 7.65 |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 30 / 30 | 28 / 30 |
| serious Total, serious adverse events | 2 / 30 | 1 / 30 |
Outcome results
Primary
Anti-gE Antibody Concentrations
Anti-gE antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL.
Time frame: Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SC GSK1437173A Group | Anti-gE Antibody Concentrations | Anti-gE, PRE | 1424.3 mIU/mL |
| SC GSK1437173A Group | Anti-gE Antibody Concentrations | Anti-gE, M2 | 19902.5 mIU/mL |
| SC GSK1437173A Group | Anti-gE Antibody Concentrations | Anti-gE, M3 | 44126.1 mIU/mL |
| IM GSK1437173A Group | Anti-gE Antibody Concentrations | Anti-gE, PRE | 1116.8 mIU/mL |
| IM GSK1437173A Group | Anti-gE Antibody Concentrations | Anti-gE, M2 | 12842 mIU/mL |
| IM GSK1437173A Group | Anti-gE Antibody Concentrations | Anti-gE, M3 | 45521.5 mIU/mL |
Primary
Descriptive Statistics of Anti-gE Antibody Concentrations
Anti-gE antibody concentrations were assessed by the Enzyme Lynked Immunosorbent Assay.
Time frame: Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| SC GSK1437173A Group | Descriptive Statistics of Anti-gE Antibody Concentrations | Anti-gE, PRE | 1404.1 mIU/mL | Standard Deviation 1398.82 |
| SC GSK1437173A Group | Descriptive Statistics of Anti-gE Antibody Concentrations | Anti-gE, M2 | 19400.1 mIU/mL | Standard Deviation 24456.86 |
| SC GSK1437173A Group | Descriptive Statistics of Anti-gE Antibody Concentrations | Anti-gE, M3 | 44182 mIU/mL | Standard Deviation 27990.99 |
| IM GSK1437173A Group | Descriptive Statistics of Anti-gE Antibody Concentrations | Anti-gE, PRE | 946.3 mIU/mL | Standard Deviation 3231.78 |
| IM GSK1437173A Group | Descriptive Statistics of Anti-gE Antibody Concentrations | Anti-gE, M2 | 14330.1 mIU/mL | Standard Deviation 14548.75 |
| IM GSK1437173A Group | Descriptive Statistics of Anti-gE Antibody Concentrations | Anti-gE, M3 | 42444.8 mIU/mL | Standard Deviation 27555.21 |
Primary
Mean Number of Days With General Symptoms
Days with solicited general symptoms were tabulated for the total vaccinated cohort.
Time frame: During the 7 day (Days 0-6) post vaccination, after 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 (MEAN) |
|---|---|---|---|
| SC GSK1437173A Group | Mean Number of Days With General Symptoms | Days with fatigue, D1 | 2.3 Days |
| SC GSK1437173A Group | Mean Number of Days With General Symptoms | Days with fever, D1 | 1.3 Days |
| SC GSK1437173A Group | Mean Number of Days With General Symptoms | Days with gastrointestinal symptoms, D1 | 2 Days |
| SC GSK1437173A Group | Mean Number of Days With General Symptoms | Days with headache, D1 | 1.8 Days |
| SC GSK1437173A Group | Mean Number of Days With General Symptoms | Days with myalgia, D1 | 6.5 Days |
| SC GSK1437173A Group | Mean Number of Days With General Symptoms | Days with Shivering, D1 | 1.3 Days |
| SC GSK1437173A Group | Mean Number of Days With General Symptoms | Days with fatigue, D2 | 2 Days |
| SC GSK1437173A Group | Mean Number of Days With General Symptoms | Days with fever, D2 | 1 Days |
| SC GSK1437173A Group | Mean Number of Days With General Symptoms | Days with gastrointestinal symptoms, D2 | 3.6 Days |
| SC GSK1437173A Group | Mean Number of Days With General Symptoms | Days with headache, D2 | 2 Days |
| SC GSK1437173A Group | Mean Number of Days With General Symptoms | Days with myalgia, D2 | 2 Days |
| SC GSK1437173A Group | Mean Number of Days With General Symptoms | Days with Shivering, D2 | 2.2 Days |
| IM GSK1437173A Group | Mean Number of Days With General Symptoms | Days with myalgia, D2 | 1.3 Days |
| IM GSK1437173A Group | Mean Number of Days With General Symptoms | Days with fatigue, D1 | 2 Days |
| IM GSK1437173A Group | Mean Number of Days With General Symptoms | Days with fatigue, D2 | 1.3 Days |
| IM GSK1437173A Group | Mean Number of Days With General Symptoms | Days with fever, D1 | 1 Days |
| IM GSK1437173A Group | Mean Number of Days With General Symptoms | Days with headache, D2 | 1.3 Days |
| IM GSK1437173A Group | Mean Number of Days With General Symptoms | Days with gastrointestinal symptoms, D1 | 2 Days |
| IM GSK1437173A Group | Mean Number of Days With General Symptoms | Days with fever, D2 | 1 Days |
| IM GSK1437173A Group | Mean Number of Days With General Symptoms | Days with headache, D1 | 1.4 Days |
| IM GSK1437173A Group | Mean Number of Days With General Symptoms | Days with Shivering, D2 | 1 Days |
| IM GSK1437173A Group | Mean Number of Days With General Symptoms | Days with myalgia, D1 | 2 Days |
| IM GSK1437173A Group | Mean Number of Days With General Symptoms | Days with gastrointestinal symptoms, D2 | 1.3 Days |
| IM GSK1437173A Group | Mean Number of Days With General Symptoms | Days with Shivering, D1 | 1.3 Days |
Primary
Mean Number of Days With Local Symptoms
Days with solicited local symptoms were tabulated for the total vaccinated cohort.
Time frame: During the 7 day (Days 0-6) post vaccination, after 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 (MEAN) |
|---|---|---|---|
| SC GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with arm movement, D1 | 3.9 Days |
| SC GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with pain, D1 | 3.3 Days |
| SC GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with injection site pruritus, D1 | 5.2 Days |
| SC GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with redness, D1 | 6.5 Days |
| SC GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with swelling, D1 | 5 Days |
| SC GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with arm movement, D2 | 2.9 Days |
| SC GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with pain, D2 | 3.4 Days |
| SC GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with injection site pruritus, D2 | 4.9 Days |
| SC GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with redness, D2 | 5.9 Days |
| SC GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with swelling, D2 | 4.3 Days |
| IM GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with injection site pruritus, D2 | 1.9 Days |
| IM GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with arm movement, D1 | 3 Days |
| IM GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with arm movement, D2 | 2.2 Days |
| IM GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with pain, D1 | 2.7 Days |
| IM GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with swelling, D2 | 2.8 Days |
| IM GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with injection site pruritus, D1 | 2.2 Days |
| IM GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with pain, D2 | 2.3 Days |
| IM GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with redness, D1 | 2.6 Days |
| IM GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with redness, D2 | 3.7 Days |
| IM GSK1437173A Group | Mean Number of Days With Local Symptoms | Days with swelling, D1 | 3 Days |
Primary
Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL)
A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value, of 18 mIU/mL.
Time frame: Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SC GSK1437173A Group | Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL) | Anti-gE, PRE | 29 Participants |
| SC GSK1437173A Group | Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL) | Anti-gE, M2 | 29 Participants |
| SC GSK1437173A Group | Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL) | Anti-gE, M3 | 29 Participants |
| IM GSK1437173A Group | Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL) | Anti-gE, PRE | 29 Participants |
| IM GSK1437173A Group | Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL) | Anti-gE, M2 | 29 Participants |
| IM GSK1437173A Group | Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL) | Anti-gE, M3 | 29 Participants |
Primary
Number of Subjects With Potential Immune-Mediated Disorders (pIMDs)
Potential immune-mediated diseases (pIMDs) were 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 Month 0 to Month 3
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SC GSK1437173A Group | Number of Subjects With Potential Immune-Mediated Disorders (pIMDs) | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Potential Immune-Mediated Disorders (pIMDs) | 0 Participants |
Primary
Number of Subjects With 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 Month 0 to Month 3
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SC GSK1437173A Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature higher than (\>) 39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination.
Time frame: During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and who had their symptom sheet filled-in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Headache, D1 | 11 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever/Axillary, Across | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Headache, D2 | 11 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, D2 | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across | 17 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fever/Axillary, D1 | 3 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, D1 | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across | 21 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, D2 | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fever/Axillary, D2 | 5 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, D2 | 16 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Headache, D1 | 11 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fever/Axillary, Across | 6 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Headache, D2 | 11 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fever/Axillary, D1 | 3 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across | 17 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Gastrointestinal symptoms, D1 | 2 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, D1 | 2 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, D2 | 5 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Gastrointestinal symptoms, D2 | 5 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Across | 7 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fever/Axillary, D2 | 5 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, D1 | 1 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Gastrointestinal symptoms, Across | 7 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, D2 | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, D1 | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Across | 1 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, D1 | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, D1 | 2 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fever/Axillary, Across | 6 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, D2 | 5 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, D2 | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Across | 7 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, D1 | 14 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Shivering, D1 | 3 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastrointestinal symptoms,Across | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Shivering, D2 | 6 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever/Axillary, D1 | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Shivering, Across | 8 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Gastrointestinal symptoms, D1 | 2 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, D1 | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across | 21 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, D2 | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Gastrointestinal symptoms, D2 | 5 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, Across | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever/Axillary, D2 | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Shivering, D1 | 3 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Gastrointestinal symptoms,Across | 7 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Shivering, D2 | 6 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, D2 | 16 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Shivering, Across | 8 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, D1 | 14 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Shivering, Across | 7 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, D1 | 12 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, D2 | 9 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across | 16 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, D1 | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, D2 | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, D1 | 12 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, D2 | 9 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across | 16 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fever/Axillary, D1 | 2 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fever/Axillary, D2 | 6 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fever/Axillary, Across | 7 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever/Axillary, D1 | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever/Axillary, D2 | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever/Axillary, Across | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fever/Axillary, D1 | 2 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fever/Axillary, D2 | 6 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fever/Axillary, Across | 7 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Gastrointestinal symptoms, D1 | 4 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Gastrointestinal symptoms, D2 | 3 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Gastrointestinal symptoms, Across | 5 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, D1 | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, D2 | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastrointestinal symptoms,Across | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Gastrointestinal symptoms, D1 | 4 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Gastrointestinal symptoms, D2 | 3 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Gastrointestinal symptoms,Across | 5 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Headache, D1 | 8 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Headache, D2 | 10 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across | 13 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, D1 | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, D2 | 2 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across | 2 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Headache, D1 | 8 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Headache, D2 | 10 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across | 13 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, D1 | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, D2 | 3 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Across | 4 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, D1 | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, D2 | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Across | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, D1 | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, D2 | 3 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Across | 4 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Shivering, D1 | 3 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Shivering, D2 | 6 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Shivering, Across | 7 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, D1 | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, D2 | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, Across | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Shivering, D1 | 3 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Shivering, D2 | 6 Participants |
Primary
Number of Subjects With Solicited Local Symptoms
The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities.
Time frame: During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and who had their symptom sheet filled-in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, D1 | 2 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Injection site pruritus, Across | 21 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, D2 | 1 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Arm movement impairment, D2 | 16 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across | 2 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Injection site pruritus, D1 | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Redness, D1 | 23 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Arm movement impairment, Across | 1 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Redness, D2 | 23 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Injection site pruritus, D2 | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across | 26 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Arm movement impairment, D1 | 1 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, D1 | 12 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Injection site pruritus, Across | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, D2 | 12 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Injection site pruritus, D1 | 19 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across | 17 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Pain, D1 | 28 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, D1 | 22 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Arm movement impairment, Across | 18 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, D2 | 20 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Pain, D2 | 25 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across | 24 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Injection site pruritus, D2 | 15 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, D1 | 8 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across | 28 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, D2 | 6 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Arm movement impairment, D2 | 0 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across | 10 Participants |
| SC GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Arm movement impairment, D1 | 10 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across | 2 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Arm movement impairment, D1 | 7 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Arm movement impairment, D2 | 11 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Arm movement impairment, Across | 12 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Arm movement impairment, D1 | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Arm movement impairment, D2 | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Arm movement impairment, Across | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Injection site pruritus, D1 | 6 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Injection site pruritus, D2 | 8 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Injection site pruritus, Across | 10 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Injection site pruritus, D1 | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Injection site pruritus, D2 | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Injection site pruritus, Across | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Pain, D1 | 26 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Pain, D2 | 21 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across | 27 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, D1 | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, D2 | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Redness, D1 | 11 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Redness, D2 | 12 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across | 15 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, D1 | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, D2 | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across | 2 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, D1 | 7 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, D2 | 11 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across | 12 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, D1 | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, D2 | 1 Participants |
Primary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: Within 30 days (Days 0-29) post vaccination period
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SC GSK1437173A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 9 Participants |
| SC GSK1437173A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 1 Participants |
| SC GSK1437173A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 1 Participants |
| IM GSK1437173A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 6 Participants |
| IM GSK1437173A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 1 Participants |
Primary
Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Time frame: At two months after Dose 1 (M2) and one month after Dose 2 (M3)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SC GSK1437173A Group | Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations | Anti-gE, M2 | 28 Participants |
| SC GSK1437173A Group | Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations | Anti-gE, M3 | 29 Participants |
| IM GSK1437173A Group | Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations | Anti-gE, M2 | 25 Participants |
| IM GSK1437173A Group | Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations | Anti-gE, M3 | 29 Participants |
Secondary
Anti-gE Antibody Concentrations
Anti-gE antibody concentrations were expressed as geometric mean concnetrations (GMCs) and measured in mIU/mL.
Time frame: At Month 14
Population: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| SC GSK1437173A Group | Anti-gE Antibody Concentrations | 15250.9 mIU/mL |
| IM GSK1437173A Group | Anti-gE Antibody Concentrations | 13870.2 mIU/mL |
Secondary
Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL
A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value of 97 mIU/mL.
Time frame: At Month 14
Population: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SC GSK1437173A Group | Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL | 30 Participants |
| IM GSK1437173A Group | Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL | 28 Participants |
Secondary
Number of Subjects With pIMDs
Potential immune-mediated diseases (pIMDs) were 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: Up to Month 14 post vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SC GSK1437173A Group | Number of Subjects With pIMDs | 0 Participants |
| IM GSK1437173A Group | Number of Subjects With pIMDs | 0 Participants |
Secondary
Number of Subjects With 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: Up to Month 14 post vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SC GSK1437173A Group | Number of Subjects With SAEs | 2 Participants |
| IM GSK1437173A Group | Number of Subjects With SAEs | 1 Participants |
Secondary
Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations
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.
Time frame: Twelve Months after Dose 2 (M14)
Population: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SC GSK1437173A Group | Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations | 25 Participants |
| IM GSK1437173A Group | Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations | 25 Participants |