Herpes Zoster, Herpes Zoster Vaccine
Conditions
Keywords
Pneumovax 23, Co-administration, Herpes zoster, Immunogenicity, Safety, Adults
Brief summary
The purpose of this study is to assess the immunogenicity, reactogenicity and safety of the GSK Biologicals HZ/su candidate vaccine when its first dose is co-administered with Pneumovax 23™ vaccine in adults aged 50 years or older.The impact of HZ/su vaccine on Pneumovax 23™ vaccine immune response will also be evaluated.
Interventions
BIOLOGICALHerpes Zoster vaccine GSK 1437173A
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
BIOLOGICALLicensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™
One dose administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female aged 50 years or older at the time of the first vaccination with the study vaccine(s). * Written informed consent obtained from the subject. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccines 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 vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine(s) and ending 30 days after the last dose of study vaccine. This includes any type of vaccine such as live, inactivated and subunit vaccines. * 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 vaccine/product. * Previous vaccination against Varicella-zoster virus (VZV) or HZ and/or planned administration during the study of an HZ or VZV vaccine other than the study vaccine. * History of HZ. * History of documented pneumococcal infection within 5 previous years. * Prior receipt of any pneumococcal vaccine or planned use of this vaccine during the study period, other than the study vaccine. * 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 vaccines. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥ 37.5°C /99.5°F by oral route. The preferred route for recording temperature in this study will be oral. * Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after the last dose of study vaccine. * Any persons with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal failure, nephrotic syndrome, and functional or anatomic asplenia. * Any condition which, in the opinion of the investigator, prevents the subject from participating in the study. * Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Vaccine Response for Anti-gE Antibodies | At Month 3 | Vaccine response rate for anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the Co-Ad group. Vaccine response defined as : For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL) For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration |
| Anti-glicoprotein E (gE) Antibody Concentrations | At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group) | Antibody concentrations were determined by ELISA, presented as geometric mean concentrations and expressed as milli international units per milliliter (mIU/mL). |
| Anti-pneumococcal Antibody Titers | At one month post-dose (Month 1) | Anti-pneumococcal antibody titers were presented as geometric mean titers (GMTs) for the 12 following serotypes as determined by Opsonophagocytic Assay (OPA): 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. |
| Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | At 1 month after vaccination | The Adjusted ratios of GMTs between groups (Control group and Co-Ad group) were presented for each individual pneumococcal conjugate serotype Opsonophagocytic Activity (OPA). |
| Adjusted GMCs Between Groups | At 1 month after last vaccine dose | The Adjusted ratios of GMCs between groups (Control group and Co-Ad group) was presented for anti-gE antibody ELISA concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [From First Vaccination up to 30 Days Post Last Vaccination] | From first vaccination up to 30 days post last vaccination (Month 0 - Month 3 for the Co-Ad Group & Month 0 - Month 5 for the Control Group) | 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 Serious Adverse Events (SAEs) [From the First Dose up to 30 Days Post Last Vaccination Period] | From the first dose up to 30 days post last 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 Any and Grade 3 Solicited Local Symptoms, by Dose | Within 7 days (Days 0 - 6) after each vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses. |
| Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [During the Period Starting After 30 Days Post Last Vaccination up to Study End] | During the period starting after 30 days post last vaccination up to study end (Month 3 - Month 14 for the Co-Ad Group & Month 5 - Month 16 for the Control Group) | 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 Serious Adverse Events (SAEs) [From 30 Days Post Last Vaccination up to Study End] | From 30 days post last vaccination up to study end | 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, Across Doses, by Vaccine | Within 7 days (Days 0 - 6) after vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Days With Any Solicited Local and General Symptoms | Within 7 days (Days 0 - 6) after each vaccination | The Co-Ad Group received only 2 vaccine doses, hence the number of participants for the Dose 3 categories in this group is 0. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | From the first dose up to 30 days post last 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. |
Countries
Canada, Estonia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Co-Ad Group Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm. | 432 |
| Control Group Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm. | 433 |
| Total | 865 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 |
| Overall Study | Lost to Follow-up | 4 | 7 |
| Overall Study | Migrated from study area | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Co-Ad Group | Control Group |
|---|---|---|---|
| Age, Continuous | 63.2 Years STANDARD_DEVIATION 8.4 | 63.2 Years STANDARD_DEVIATION 8.4 | 63.2 Years STANDARD_DEVIATION 8.4 |
| Race/Ethnicity, Customized African Heritage / African American | 21 Participants | 12 Participants | 9 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 4 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 10 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 6 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Mixed Origin | 7 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White - Arabic / North African Heritage | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 814 Participants | 408 Participants | 406 Participants |
| Sex: Female, Male Female | 516 Participants | 264 Participants | 252 Participants |
| Sex: Female, Male Male | 349 Participants | 168 Participants | 181 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 432 | 5 / 433 |
| other Total, other adverse events | 400 / 432 | 393 / 433 |
| serious Total, serious adverse events | 17 / 432 | 19 / 433 |
Outcome results
Primary
Adjusted GMCs Between Groups
The Adjusted ratios of GMCs between groups (Control group and Co-Ad group) was presented for anti-gE antibody ELISA concentrations
Time frame: At 1 month after last vaccine dose
Population: This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Co-Ad Group | Adjusted GMCs Between Groups | 49569.0 mIU/mL |
| Control Group | Adjusted GMCs Between Groups | 50474.5 mIU/mL |
Comparison: Adjusted ratios of GMCs between groups (Control group and Co-Ad group) for anti-gE antibody ELISA concentrations95% CI: [0.93, 1.11]ANCOVA
Primary
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
The Adjusted ratios of GMTs between groups (Control group and Co-Ad group) were presented for each individual pneumococcal conjugate serotype Opsonophagocytic Activity (OPA).
Time frame: At 1 month after vaccination
Population: This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Co-Ad Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-1 | 67.6 Titers |
| Co-Ad Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-18C | 1040.9 Titers |
| Co-Ad Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-6B | 1536.8 Titers |
| Co-Ad Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-3 | 105.0 Titers |
| Co-Ad Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-4 | 1264.1 Titers |
| Co-Ad Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-5 | 152.6 Titers |
| Co-Ad Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-7F | 2491.3 Titers |
| Co-Ad Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-9V | 1911.8 Titers |
| Co-Ad Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-14 | 2610.1 Titers |
| Co-Ad Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-19A | 1558.6 Titers |
| Co-Ad Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-19F | 938.2 Titers |
| Co-Ad Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-23F | 372.8 Titers |
| Control Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-6B | 1666.6 Titers |
| Control Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-14 | 2678.1 Titers |
| Control Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-18C | 1099.8 Titers |
| Control Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-23F | 419.1 Titers |
| Control Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-7F | 2324.7 Titers |
| Control Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-1 | 65.6 Titers |
| Control Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-19F | 914.1 Titers |
| Control Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-3 | 108.9 Titers |
| Control Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-9V | 1970.3 Titers |
| Control Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-4 | 1117.2 Titers |
| Control Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-19A | 1350.5 Titers |
| Control Group | Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups | MOPA-5 | 159.8 Titers |
Comparison: Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-1.95% CI: [0.81, 1.31]ANCOVA
Comparison: Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-395% CI: [0.8, 1.16]ANCOVA
Comparison: Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-495% CI: [0.92, 1.4]ANCOVA
Comparison: Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-595% CI: [0.75, 1.21]ANCOVA
Comparison: Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-6B95% CI: [0.73, 1.16]ANCOVA
Comparison: Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-7F95% CI: [0.89, 1.29]ANCOVA
Comparison: Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-9V95% CI: [0.79, 1.19]ANCOVA
Comparison: Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-1495% CI: [0.81, 1.18]ANCOVA
Comparison: Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-18C95% CI: [0.77, 1.16]ANCOVA
Comparison: Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19A95% CI: [0.95, 1.4]ANCOVA
Comparison: Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19F95% CI: [0.84, 1.25]ANCOVA
Comparison: Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-23F95% CI: [0.7, 1.12]ANCOVA
Primary
Anti-glicoprotein E (gE) Antibody Concentrations
Antibody concentrations were determined by ELISA, presented as geometric mean concentrations and expressed as milli international units per milliliter (mIU/mL).
Time frame: At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)
Population: This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Co-Ad Group | Anti-glicoprotein E (gE) Antibody Concentrations | 49918.0 mIU/mL |
| Control Group | Anti-glicoprotein E (gE) Antibody Concentrations | 50327.9 mIU/mL |
Primary
Anti-pneumococcal Antibody Titers
Anti-pneumococcal antibody titers were presented as geometric mean titers (GMTs) for the 12 following serotypes as determined by Opsonophagocytic Assay (OPA): 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
Time frame: At one month post-dose (Month 1)
Population: This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-1 | 65.1 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-23F | 431.4 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-9V | 1898.4 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-14 | 2629.4 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-3 | 106.7 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-4 | 1079.4 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-5 | 161.4 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-6B | 1619.0 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-7F | 2352.5 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-18C | 1077.4 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-19A | 1349.6 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-19F | 904.3 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-4 | 1328.8 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-1 | 68.6 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-19F | 953.0 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-7F | 2460.4 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-23F | 367.3 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-5 | 149.5 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-9V | 1991.3 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-19A | 1573.1 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-14 | 2612.8 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-6B | 1564.4 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-3 | 107.4 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-18C | 1076.0 Titers |
Primary
Number of Subjects With a Vaccine Response for Anti-gE Antibodies
Vaccine response rate for anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the Co-Ad group. Vaccine response defined as : For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL) For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration
Time frame: At Month 3
Population: This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Co-Ad Group | Number of Subjects With a Vaccine Response for Anti-gE Antibodies | 394 Participants |
Secondary
Number of Days With Any Solicited Local and General Symptoms
The Co-Ad Group received only 2 vaccine doses, hence the number of participants for the Dose 3 categories in this group is 0.
Time frame: Within 7 days (Days 0 - 6) after each vaccination
Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Headache, Dose 2 | 2 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Redness, Dose 1 | 3 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Fatigue, Dose 2 | 2 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Myalgia, Dose 1 | 2 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Swelling, Dose 1 | 3 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Myalgia, Dose 2 | 2 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Pain, Dose 1 | 3 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Gastrointestinal, Dose 1 | 2 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Shivering, Dose 1 | 1 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Redness, Dose 2 | 3 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Shivering, Dose 2 | 1 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Gastrointestinal, Dose 2 | 2 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Pain, Dose 2 | 3 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Temperature (Oral), Dose 1 | 1 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Fatigue, Dose 1 | 2 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Temperature (Oral), Dose 2 | 1 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Headache, Dose 1 | 2 days |
| Co-Ad Group | Number of Days With Any Solicited Local and General Symptoms | Any Swelling, Dose 2 | 3 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Headache, Dose 3 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Myalgia, Dose 1 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Myalgia, Dose 2 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Myalgia, Dose 3 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Shivering, Dose 1 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Shivering, Dose 2 | 1 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Shivering, Dose 3 | 1 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Temperature (Oral), Dose 1 | 1 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Temperature (Oral), Dose 2 | 1 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Temperature (Oral), Dose 3 | 1 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Headache, Dose 1 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Pain, Dose 1 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Pain, Dose 2 | 3 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Pain, Dose 3 | 3 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Redness, Dose 1 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Redness, Dose 2 | 3 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Redness, Dose 3 | 3 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Swelling, Dose 1 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Swelling, Dose 2 | 4 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Swelling, Dose 3 | 3 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Fatigue, Dose 1 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Fatigue, Dose 2 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Fatigue, Dose 3 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Gastrointestinal, Dose 1 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Gastrointestinal, Dose 2 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Gastrointestinal, Dose 3 | 2 days |
| Control Group | Number of Days With Any Solicited Local and General Symptoms | Any Headache, Dose 2 | 2 days |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.
Time frame: Within 7 days (Days 0 - 6) after each vaccination
Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Dose 1 | 99 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Dose 1 | 344 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Dose 1 | 46 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Dose 1 | 182 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Dose 1 | 15 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Dose 1 | 4 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Dose 2 | 298 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Dose 2 | 35 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Dose 2 | 146 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Dose 2 | 15 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Dose 2 | 79 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Dose 2 | 4 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Across Doses | 372 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Across Doses | 68 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Across Doses | 233 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Across Doses | 27 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Across Doses | 137 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Across Doses | 7 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Across Doses | 115 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Dose 3 | 136 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Dose 2 | 67 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Dose 3 | 8 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Across Doses | 357 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Dose 1 | 169 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Dose 2 | 2 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Dose 1 | 5 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Dose 3 | 293 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Dose 1 | 31 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Across Doses | 12 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Dose 1 | 2 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Dose 3 | 32 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Dose 1 | 21 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Across Doses | 49 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Across Doses | 6 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Pain, Dose 2 | 290 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Swelling, Dose 3 | 74 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Pain, Dose 2 | 28 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Across Doses | 194 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Any Redness, Dose 2 | 129 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Swelling, Dose 3 | 3 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Grade 3 Redness, Dose 2 | 4 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: This analysis was performed on the Total Vaccinated cohort, including subjects with at least one vaccine dose administered, only on those subjects with completed symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 1 | 187 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 1 | 69 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms, Dose 2 | 6 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms, Dose 2 | 52 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 2 | 141 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 2 | 182 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 2 | 63 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Across doses | 236 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Across doses | 46 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 1 | 194 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 1 | 27 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 1 | 175 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms, Dose 1 | 76 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms, Dose 1 | 6 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms, Dose 1 | 67 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 1 | 156 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 1 | 15 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 1 | 141 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 1 | 29 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 1 | 177 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Dose 1 | 91 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Dose 1 | 12 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Dose 1 | 86 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Dose 1 | 1 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 1 | 67 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 2 | 191 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 2 | 29 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 2 | 174 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms, Dose 2 | 61 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 2 | 19 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 2 | 124 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 2 | 25 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 2 | 171 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Dose 2 | 83 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Dose 2 | 14 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Dose 2 | 78 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 2 | 67 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Dose 2 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Across doses | 253 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Across doses | 47 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms, Across doses | 114 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms, Across doses | 12 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms, Across doses | 100 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Across doses | 209 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Across doses | 29 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Across doses | 195 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Across doses | 257 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Across doses | 245 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Across doses | 137 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Across doses | 25 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Across doses | 131 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Across doses | 112 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Across doses | 1 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Across doses | 108 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Dose 3 | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 1 | 64 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Dose 2 | 25 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Dose 1 | 27 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Dose 1 | 26 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Across doses | 15 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 1 | 12 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 2 | 30 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms, Dose 2 | 4 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 3 | 66 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 2 | 26 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 2 | 124 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 3 | 174 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 3 | 22 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Across doses | 193 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Across doses | 31 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 3 | 166 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Across doses | 225 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Across doses | 228 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Across doses | 37 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms, Dose 3 | 47 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 1 | 87 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Across doses | 91 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms, Dose 3 | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 1 | 81 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Across doses | 216 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms, Dose 1 | 31 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms, Dose 3 | 46 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Across doses | 95 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms, Dose 1 | 28 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 3 | 144 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 1 | 72 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms, Across doses | 84 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 1 | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 3 | 13 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 1 | 87 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Across doses | 218 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 1 | 5 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 3 | 135 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 1 | 82 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms, Across doses | 7 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 3 | 162 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Across doses | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 3 | 26 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms, Across doses | 77 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 1 | 11 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 3 | 157 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 2 | 124 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Across doses | 99 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 2 | 11 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Dose 3 | 72 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 2 | 109 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Across doses | 208 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms, Dose 2 | 38 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms, Dose 2 | 29 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 2 | 104 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Dose 3 | 11 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 2 | 9 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Across doses | 96 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 2 | 85 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Dose 3 | 69 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 2 | 11 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 1 | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 2 | 119 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 3 | 67 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Dose 2 | 30 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Across doses | 24 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Dose 2 | 3 Participants |
Secondary
Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [During the Period Starting After 30 Days Post Last Vaccination up to Study End]
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: During the period starting after 30 days post last vaccination up to study end (Month 3 - Month 14 for the Co-Ad Group & Month 5 - Month 16 for the Control Group)
Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Co-Ad Group | Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [During the Period Starting After 30 Days Post Last Vaccination up to Study End] | 1 Participants |
| Control Group | Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [During the Period Starting After 30 Days Post Last Vaccination up to Study End] | 0 Participants |
Secondary
Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [From First Vaccination up to 30 Days Post Last Vaccination]
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 for the Co-Ad Group & Month 0 - Month 5 for the Control Group)
Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Ad Group | Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [From First Vaccination up to 30 Days Post Last Vaccination] | Any pIMDs | 0 Participants |
| Co-Ad Group | Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [From First Vaccination up to 30 Days Post Last Vaccination] | Related pIMDs | 0 Participants |
| Control Group | Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [From First Vaccination up to 30 Days Post Last Vaccination] | Any pIMDs | 1 Participants |
| Control Group | Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [From First Vaccination up to 30 Days Post Last Vaccination] | Related pIMDs | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) [From 30 Days Post Last Vaccination up to Study End]
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 30 days post last vaccination up to study end
Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Ad Group | Number of Subjects With Serious Adverse Events (SAEs) [From 30 Days Post Last Vaccination up to Study End] | Subjects with any SAE(s) | 10 Participants |
| Co-Ad Group | Number of Subjects With Serious Adverse Events (SAEs) [From 30 Days Post Last Vaccination up to Study End] | Fatal SAE(s) | 2 Participants |
| Co-Ad Group | Number of Subjects With Serious Adverse Events (SAEs) [From 30 Days Post Last Vaccination up to Study End] | Related SAE(s) | 2 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) [From 30 Days Post Last Vaccination up to Study End] | Subjects with any SAE(s) | 10 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) [From 30 Days Post Last Vaccination up to Study End] | Fatal SAE(s) | 2 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) [From 30 Days Post Last Vaccination up to Study End] | Related SAE(s) | 2 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) [From the First Dose up to 30 Days Post Last 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.
Time frame: From the first dose up to 30 days post last vaccination period
Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Ad Group | Number of Subjects With Serious Adverse Events (SAEs) [From the First Dose up to 30 Days Post Last Vaccination Period] | Subjects with any SAE(s) | 7 Participants |
| Co-Ad Group | Number of Subjects With Serious Adverse Events (SAEs) [From the First Dose up to 30 Days Post Last Vaccination Period] | Fatal SAEs | 0 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) [From the First Dose up to 30 Days Post Last Vaccination Period] | Subjects with any SAE(s) | 9 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) [From the First Dose up to 30 Days Post Last Vaccination Period] | Fatal SAEs | 0 Participants |
Secondary
Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: Within 7 days (Days 0 - 6) after vaccination
Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Ad Group | Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine | Any Swelling, Pneumovax 23, Across Doses | 36 Participants |
| Co-Ad Group | Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine | Any Pain, GSK1437173A, Across Doses | 369 Participants |
| Co-Ad Group | Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine | Any Pain, Pneumovax 23, Across Doses | 223 Participants |
| Co-Ad Group | Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine | Any Redness, GSK1437173A, Across Doses | 223 Participants |
| Co-Ad Group | Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine | Any Redness, Pneumovax 23, Across Doses | 69 Participants |
| Co-Ad Group | Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine | Any Swelling, GSK1437173A, Across Doses | 129 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine | Any Redness, Pneumovax 23, Across Doses | 31 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine | Any Swelling, Pneumovax 23, Across Doses | 21 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine | Any Redness, GSK1437173A, Across Doses | 186 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine | Any Pain, GSK1437173A, Across Doses | 343 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine | Any Swelling, GSK1437173A, Across Doses | 108 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine | Any Pain, Pneumovax 23, Across Doses | 169 Participants |
Secondary
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: From the first dose up to 30 days post last vaccination period
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Ad Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Subjects with any AE(s) | 132 Participants |
| Co-Ad Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Subjects with grade 3 AE(s) | 16 Participants |
| Co-Ad Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Subjects with related AE(s) | 34 Participants |
| Control Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Subjects with any AE(s) | 140 Participants |
| Control Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Subjects with grade 3 AE(s) | 28 Participants |
| Control Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Subjects with related AE(s) | 28 Participants |