Herpes Zoster, Herpes Zoster Vaccine
Conditions
Keywords
Safety, Zoster, Immunogenicity, Adults, Consistency
Brief summary
The purpose of this study is to demonstrate lot-to-lot consistency in terms of immunogenicity, and evaluate safety of the Herpes Zoster subunit (HZ/su) vaccine. The study is designed as a randomized, double-blind study with three parallel groups.
Interventions
BIOLOGICALHerpes Zoster vaccine (GSK 1437173A)
2 doses administered intramuscularly in deltoid region of non-dominant arm.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
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 2 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. A prednisone dose of \< 20 mg/day 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 the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine (E.g. inactivated and subunit vaccines) within 8 days prior to or within 14 days after either dose of study vaccine. * Administration of long-acting immune-modifying drugs within six months prior to the first vaccine dose or expected administration at any time during the study period. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Previous vaccination against HZ or varicella. * Planned administration during the study of an HZ or varicella vaccine other than the study vaccine. * History of HZ. * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Acute disease and/or fever at the time of enrollment. * Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic route, or ≥ 38.0°C (100.4°F) on rectal route. The preferred route for recording temperature in this study will be oral. * Subjects with a minor illness without fever may be enrolled at the discretion of the investigator. * Administration of immunoglobulins and/or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period. * Pregnant or lactating females. * Females planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 4. * Any condition which, in the opinion of the investigator, prevents the subject from participating in the study. * Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study. * Any condition which, in the judgment of the investigator would make intramuscular injection unsafe.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value | At Month 3 | Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA | At Month 3 | 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 Any and Grade 3 Solicited Local Symptoms | Within 7 days (Days 0-6) after each vaccine dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activities. |
| Number of Days With Any Solicited Local Symptoms | During the 7 days (Days 0-6) after each vaccine dose | The number of days with any local symptoms reported during the solicited post-vaccination period. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within 7 days (Days 0-6) after each vaccine dose and across doses | Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and temperature \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature= temperature \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Anti-gE Humoral Immunogenicity | At Month 0 and Month 3 | Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter (mIU/mL). |
| Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 until study end (Month 14) | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During 30 days (Days 0-29) after each vaccination | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any Serious Adverse Events (SAEs) | From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 to study end (Month 14) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Days With Any Solicited General Symptoms | During the 7 days (Days 0-6) after each vaccine dose | The number of days with any general symptoms reported during the solicited post-vaccination period. |
Countries
Belgium, Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK1437173A Lot A Group Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months. | 218 |
| GSK1437173A Lot B Group Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months. | 217 |
| GSK1437173A Lot C Group Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months. | 216 |
| Total | 651 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 | 6 |
| Overall Study | Non-Serious Adverse Event | 0 | 1 | 0 |
| Overall Study | Serious Adverse Event | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | GSK1437173A Lot A Group | GSK1437173A Lot B Group | GSK1437173A Lot C Group | Total |
|---|---|---|---|---|
| Age, Continuous | 64.8 Years STANDARD_DEVIATION 8.8 | 64.3 Years STANDARD_DEVIATION 9.4 | 64.4 Years STANDARD_DEVIATION 8.8 | 64.5 Years STANDARD_DEVIATION 8.99 |
| Sex: Female, Male Female | 116 Participants | 130 Participants | 114 Participants | 360 Participants |
| Sex: Female, Male Male | 102 Participants | 87 Participants | 102 Participants | 291 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 | 202 / 218 | 201 / 217 | 198 / 216 |
| serious Total, serious adverse events | 13 / 218 | 14 / 217 | 20 / 216 |
Outcome results
Primary
Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value
Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL).
Time frame: At Month 3
Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1437173A Lot A Group | Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value | 210 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value | 210 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value | 202 Subjects |
95% CI: [0.86, 1.09]ANCOVA
95% CI: [0.85, 1.08]ANCOVA
95% CI: [0.88, 1.1]ANCOVA
Secondary
Anti-gE Humoral Immunogenicity
Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter (mIU/mL).
Time frame: At Month 0 and Month 3
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A Lot A Group | Anti-gE Humoral Immunogenicity | Anti-gE, Month 0 | 1378.4 mIU/mL |
| GSK1437173A Lot A Group | Anti-gE Humoral Immunogenicity | Anti-gE, Month 3 | 59556.1 mIU/mL |
| GSK1437173A Lot B Group | Anti-gE Humoral Immunogenicity | Anti-gE, Month 0 | 1166.5 mIU/mL |
| GSK1437173A Lot B Group | Anti-gE Humoral Immunogenicity | Anti-gE, Month 3 | 60733.8 mIU/mL |
| GSK1437173A Lot C Group | Anti-gE Humoral Immunogenicity | Anti-gE, Month 0 | 1381.2 mIU/mL |
| GSK1437173A Lot C Group | Anti-gE Humoral Immunogenicity | Anti-gE, Month 3 | 62058.3 mIU/mL |
Secondary
Number of Days With Any Solicited General Symptoms
The number of days with any general symptoms reported during the solicited post-vaccination period.
Time frame: During the 7 days (Days 0-6) after each vaccine dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1437173A Lot A Group | Number of Days With Any Solicited General Symptoms | Fatigue post-Dose 1 | 2.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited General Symptoms | Fatigue post-Dose 2 | 2.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited General Symptoms | Gastrointestinal symptoms post-Dose 1 | 1.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited General Symptoms | Gastrointestinal symptoms post-Dose 2 | 1.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited General Symptoms | Headache post-Dose 1 | 1.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited General Symptoms | Headache post-Dose 2 | 1.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited General Symptoms | Myalgia post-Dose 1 | 2.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited General Symptoms | Myalgia post-Dose 2 | 2.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited General Symptoms | Shivering post-Dose 1 | 1.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited General Symptoms | Shivering post-Dose 2 | 1.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited General Symptoms | Temperature post-Dose 1 | 1.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited General Symptoms | Temperature post-Dose 2 | 1.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited General Symptoms | Temperature post-Dose 2 | 1.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited General Symptoms | Fatigue post-Dose 1 | 2.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited General Symptoms | Myalgia post-Dose 1 | 2.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited General Symptoms | Shivering post-Dose 1 | 2.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited General Symptoms | Fatigue post-Dose 2 | 2.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited General Symptoms | Headache post-Dose 2 | 1.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited General Symptoms | Temperature post-Dose 1 | 1.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited General Symptoms | Gastrointestinal symptoms post-Dose 1 | 1.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited General Symptoms | Myalgia post-Dose 2 | 2.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited General Symptoms | Headache post-Dose 1 | 1.5 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited General Symptoms | Gastrointestinal symptoms post-Dose 2 | 1.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited General Symptoms | Shivering post-Dose 2 | 1.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited General Symptoms | Gastrointestinal symptoms post-Dose 2 | 1.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited General Symptoms | Headache post-Dose 1 | 2.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited General Symptoms | Shivering post-Dose 2 | 1.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited General Symptoms | Headache post-Dose 2 | 2.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited General Symptoms | Myalgia post-Dose 1 | 2.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited General Symptoms | Myalgia post-Dose 2 | 2.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited General Symptoms | Temperature post-Dose 1 | 1.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited General Symptoms | Fatigue post-Dose 1 | 2.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited General Symptoms | Fatigue post-Dose 2 | 1.5 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited General Symptoms | Shivering post-Dose 1 | 1.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited General Symptoms | Gastrointestinal symptoms post-Dose 1 | 1.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited General Symptoms | Temperature post-Dose 2 | 1.0 Days |
Secondary
Number of Days With Any Solicited Local Symptoms
The number of days with any local symptoms reported during the solicited post-vaccination period.
Time frame: During the 7 days (Days 0-6) after each vaccine dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1437173A Lot A Group | Number of Days With Any Solicited Local Symptoms | Swelling post-Dose 2 | 3.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited Local Symptoms | Swelling post-Dose 1 | 2.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited Local Symptoms | Pain post-Dose 2 | 2.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited Local Symptoms | Pain post-Dose 1 | 2.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited Local Symptoms | Redness post-Dose 2 | 3.0 Days |
| GSK1437173A Lot A Group | Number of Days With Any Solicited Local Symptoms | Redness post-Dose 1 | 2.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited Local Symptoms | Pain post-Dose 1 | 3.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited Local Symptoms | Swelling post-Dose 1 | 2.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited Local Symptoms | Swelling post-Dose 2 | 3.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited Local Symptoms | Redness post-Dose 1 | 3.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited Local Symptoms | Redness post-Dose 2 | 3.0 Days |
| GSK1437173A Lot B Group | Number of Days With Any Solicited Local Symptoms | Pain post-Dose 2 | 2.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited Local Symptoms | Swelling post-Dose 2 | 3.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited Local Symptoms | Redness post-Dose 2 | 3.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited Local Symptoms | Pain post-Dose 1 | 3.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited Local Symptoms | Pain post-Dose 2 | 2.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited Local Symptoms | Swelling post-Dose 1 | 3.0 Days |
| GSK1437173A Lot C Group | Number of Days With Any Solicited Local Symptoms | Redness post-Dose 1 | 2.0 Days |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activities.
Time frame: Within 7 days (Days 0-6) after each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered, only on those subjects with the symptoms sheet filled in.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 160 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 52 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 4 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 155 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 29 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 3 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 24 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 1 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 188 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 38 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 22 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 22 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 38 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 4 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 18 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 3 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 3 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 68 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 152 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 2 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 196 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 179 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 1 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 6 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 48 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 1 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 33 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 13 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 47 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 28 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 16 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 3 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 44 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 7 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 62 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 155 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 43 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 2 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 185 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 2 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 25 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 3 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 1 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 41 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 1 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 26 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 7 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 166 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 39 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 13 Subjects |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and temperature \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature= temperature \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: Within 7 days (Days 0-6) after each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered, only on those subjects with the symptom sheets filled in.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 66 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 30 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 74 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 11 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 66 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 5 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 62 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 23 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 1 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 19 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 63 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 5 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 59 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 85 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 4 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 71 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 31 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 1 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 28 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 24 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 91 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 14 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 89 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 33 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 2 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 29 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 9 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 69 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 99 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 20 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 85 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 67 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 43 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 2 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 40 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across Doses | 114 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across Doses | 18 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across Doses | 111 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across Doses | 46 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Gastrointestinal,Across Doses | 3 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across Doses | 101 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across Doses | 13 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across Doses | 95 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across Doses | 128 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across Doses | 24 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across Doses | 112 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across Doses | 80 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across Doses | 12 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across Doses | 79 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across Doses | 59 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across Doses | 2 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across Doses | 53 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across Doses | 41 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 80 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 68 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 11 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across Doses | 13 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across Doses | 39 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 85 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 76 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across Doses | 109 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 34 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across Doses | 12 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across Doses | 7 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across Doses | 107 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 21 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 21 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across Doses | 11 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 4 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 91 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 63 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 11 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across Doses | 0 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 22 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 81 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across Doses | 102 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across Doses | 49 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 2 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 20 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 60 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across Doses | 46 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 68 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 5 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across Doses | 45 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 4 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 7 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 59 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 63 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across Doses | 65 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 89 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across Doses | 119 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Gastrointestinal,Across Doses | 2 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 3 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 34 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 29 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 78 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across Doses | 67 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 80 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across Doses | 101 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 4 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 19 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 33 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across Doses | 108 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 23 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 64 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across Doses | 89 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across Doses | 41 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 19 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 82 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 6 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 76 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across Doses | 82 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 29 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across Doses | 43 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 5 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 7 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 66 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across Doses | 113 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 5 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across Doses | 46 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 63 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 83 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across Doses | 10 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 76 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across Doses | 102 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 7 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 43 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across Doses | 1 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 25 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 1 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across Doses | 60 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 25 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 4 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 28 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 44 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across Doses | 107 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 22 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across Doses | 10 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 58 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across Doses | 7 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 26 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 4 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across Doses | 103 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 23 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 49 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 4 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across Doses | 50 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 43 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 76 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 4 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Gastrointestinal,Across Doses | 9 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 62 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across Doses | 9 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 22 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across Doses | 58 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 21 Subjects |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During 30 days (Days 0-29) after each vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 23 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 13 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 72 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 15 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 69 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 22 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 76 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 27 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 9 Subjects |
Secondary
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology
Time frame: From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 until study end (Month 14)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1437173A Lot A Group | Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | pIMDs from Month 0 to Month 3 | 3 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | pIMDs from Month 4 to Month 14 | 2 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | pIMDs from Month 0 to Month 3 | 0 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | pIMDs from Month 4 to Month 14 | 0 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | pIMDs from Month 0 to Month 3 | 1 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | pIMDs from Month 4 to Month 14 | 2 Subjects |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 to study end (Month 14)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1437173A Lot A Group | Number of Subjects With Any Serious Adverse Events (SAEs) | SAEs from Month 0 to Month 3 | 5 Subjects |
| GSK1437173A Lot A Group | Number of Subjects With Any Serious Adverse Events (SAEs) | SAEs from Month 4 to Month 14 | 10 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any Serious Adverse Events (SAEs) | SAEs from Month 0 to Month 3 | 7 Subjects |
| GSK1437173A Lot B Group | Number of Subjects With Any Serious Adverse Events (SAEs) | SAEs from Month 4 to Month 14 | 8 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any Serious Adverse Events (SAEs) | SAEs from Month 0 to Month 3 | 4 Subjects |
| GSK1437173A Lot C Group | Number of Subjects With Any Serious Adverse Events (SAEs) | SAEs from Month 4 to Month 14 | 16 Subjects |
Secondary
Number of Vaccine Responders for Anti-gE Concentrations as Determined by 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.
Time frame: At Month 3
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1437173A Lot A Group | Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA | 201 Subjects |
| GSK1437173A Lot B Group | Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA | 205 Subjects |
| GSK1437173A Lot C Group | Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA | 197 Subjects |