Herpes Zoster
Conditions
Keywords
HZ, Safety, Immunogenicity, Shingles, Adults, Prevenar 13
Brief summary
The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.
Detailed description
Following the initial approval of the GlaxoSmithKline (GSK) Biologicals' HZ/su vaccine, the protocol was amended to indicate that the trademark is Shingrix. In addition, the term candidate vaccine has been replaced by study vaccine throughout the protocol.
Interventions
BIOLOGICALHZ/su vaccine GSK1437173A
2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.
BIOLOGICALPrevenar13
1 dose of 0.5 mL of the vaccine. Administered by intramuscular injection into the deltoid muscle of the 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. * Written informed consent obtained from the subject prior to performance of any study specific procedure. * A male or female, aged ≥50 YOA at the time of the first vaccination with the study vaccine(s). * Female subjects of non-childbearing potential may be enrolled in the study. * 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 during the period starting 30 days before the first dose of study vaccines (Day -30 to Day 1), or planned use during the study period. * Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe. * Use or anticipated use of immunosuppressants or other immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids (\>14 consecutive days of prednisone at a dose of ≥20 mg/day \[or equivalent\]), long-acting immune modifying agents or immunosuppressive/cytotoxic therapy. Inhaled, topical and intra-articular corticosteroids are allowed. * Administration or planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines. * 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 and/or planned administration of an HZ or VZV vaccine other than the study vaccine during the study period. * History of HZ. * History of documented pneumococcal infection within 5 previous years. * Prior receipt of any pneumococcal vaccine or planned use during the study period, other than the study vaccines. * 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 enrollment. * Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity. * Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator. * Administration of immunoglobulins and/or any blood products during the period starting 3 months before 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 person with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal failure, nephrotic syndrome and functional or anatomic asplenia. * Any medical condition that in the judgment of the investigator would prevent the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group | One month post-dose 2 (Month 3) | Vaccine response rate (VRR) for Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) humoral immunogenicity was determined by Enzyme Limked Immunosorbent Assay (ELISA). The VRR for anti-gE is defined as the percentage of subjects who had at least: a 4-fold increase in the anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the anti-gE antibodies concentration as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who are seronegative at baseline. |
| Anti-gE Antibody Concentrations | One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group). | Anti-gE antibody concentrations in terms of Geometric Mean concentrations (GMC) were determined by ELISA and expressed as milli-international units per milliliter (mIU/mL) |
| Anti-pneumococcal Antibody Titers | At one month post-dose 1 (Month 1) | Anti-pneumococcal antibody titers for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were determined by Multiplex Opsonophagocytosis Assay (MOPA) |
| Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody | One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group). | Anti-gE antibody concentrations (GMCs) adjusted for age and baseline concentrations were determined using Analysis Of Covariance (ANCOVA) model. Adjusted GMCs were expressed in milli-international units per milliliter (mIU/mL) |
| Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | At one month post-dose 1 (Month 1) | Geometric mean antibody (anti-pneumococcal antibodies: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) titers adjusted for age and baseline concentration were determined using ANCOVA model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Related Serious Adverse Events (SAE) From Day 1 to 30 Days Post Last Vaccination | From first vaccination at Day 1 up to 30 days post last vaccination | SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= SAEs assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any and Related SAEs From 30 Days Post Last Vaccination up to Study End. | From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group) | Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= SAEs assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Within 7 days (Day 1 - 7) after each vaccination | Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 erythema/swelling = erythema/swelling that had spread beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses. |
| Number of Subjects With Any pIMDs From 30 Days Post Last Vaccination up to Study End. | From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group) | pIMDs assessed were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not had an autoimmune aetiology. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Within 7 days (Day 1 - 7) after each vaccination | Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 erythema/swelling = erythema/swelling that had spread beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses. |
| Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) From Day 1 to 30 Days Post Last Vaccination | From first vaccination at Day 1 up to 30 days post last vaccination. | pIMDs assessed were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not had an autoimmune aetiology. Related pIMDs= pIMDs assessed by the investigator as causally related to the study vaccination. |
| Number of Days With Each Solicited Local Symptoms | Within 7 days (Day 1 - 7) after each vaccination | The number of days with any local symptoms had been assessed during the post-vaccination period. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within 7 days (Day 1 - 7) after each vaccination | Assessed solicited general symptoms were fatigue, fever \[defined as oral temperature ≥ 38.0 degrees Celsius (°C)/ 100.4 degrees Fahrenheit (°F)\], GastroIntestinal (GI) symptoms, headache, myalgia and shivering. 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 Solicited General Symptoms | Within 7 days (Day 1 - 7) after each vaccination | The number of days with any general symptoms had been assessed during the post-vaccination period. Assessed solicited general symptoms were fatigue, fever, GastroIntestinal (GI) symptoms, headache, myalgia and shivering. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE) | Within 30 days (Day 1 to 30) after each vaccination | An unsolicited AE covered 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, Germany, United States
Participant flow
Recruitment details
The study was conducted in 4 countries (Canada, Estonia, Germany & United States)
Pre-assignment details
Out of 913 subjects enrolled in the study, 1 subject violated protocol prior to randomization. 912 subjects were vaccinated and included in the Exposed Set, 901 subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Co-Ad Group Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm | 449 |
| Control Group Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm | 463 |
| Total | 912 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Consent withdrawal, not due to an Adverse Event | 3 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Control Group | Total | Co-Ad Group |
|---|---|---|---|
| Age, Continuous | 63.2 Years STANDARD_DEVIATION 8.4 | 63.1 Years STANDARD_DEVIATION 8.4 | 63.1 Years STANDARD_DEVIATION 8.3 |
| Race/Ethnicity, Customized American Indian Or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black Or African American | 8 Participants | 16 Participants | 8 Participants |
| Race/Ethnicity, Customized Mixed Origin | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White - Arabic / North African Heritage | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 452 Participants | 891 Participants | 439 Participants |
| Sex: Female, Male Female | 284 Participants | 543 Participants | 259 Participants |
| Sex: Female, Male Male | 179 Participants | 369 Participants | 190 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 449 | 4 / 463 |
| other Total, other adverse events | 419 / 449 | 427 / 463 |
| serious Total, serious adverse events | 16 / 449 | 16 / 463 |
Outcome results
Primary
Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody
Anti-gE antibody concentrations (GMCs) adjusted for age and baseline concentrations were determined using Analysis Of Covariance (ANCOVA) model. Adjusted GMCs were expressed in milli-international units per milliliter (mIU/mL)
Time frame: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
Population: Analysis was performed on the PPS for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Co-Ad Group | Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody | 58526.8 mlU/mL |
| Control Group | Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody | 54634.9 mlU/mL |
Comparison: Anti-gE GMCs (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean concentrations (GMCs) for anti-gE antibodies, one month after the administration of last vaccine dose.95% CI: [0.99, 1.16]ANCOVA
Primary
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies
Geometric mean antibody (anti-pneumococcal antibodies: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) titers adjusted for age and baseline concentration were determined using ANCOVA model.
Time frame: At one month post-dose 1 (Month 1)
Population: Analysis was performed on the PPS for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Co-Ad Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-4 | 1331.6 Titers |
| Co-Ad Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-9V | 2955.8 Titers |
| Co-Ad Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-6A | 2253.8 Titers |
| Co-Ad Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-14 | 1992.3 Titers |
| Co-Ad Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-3 | 99.6 Titers |
| Co-Ad Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-18C | 1558.9 Titers |
| Co-Ad Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-6B | 1967.3 Titers |
| Co-Ad Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-19A | 1663.5 Titers |
| Co-Ad Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-5 | 278.9 Titers |
| Co-Ad Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-19F | 760.2 Titers |
| Co-Ad Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-7F | 2337.3 Titers |
| Co-Ad Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-23F | 896.6 Titers |
| Co-Ad Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-1 | 147.1 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-23F | 748.2 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-1 | 141.2 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-3 | 97.3 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-4 | 1066.9 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-5 | 269.1 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-6A | 1784.4 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-6B | 1445.4 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-7F | 1935.1 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-9V | 2553.5 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-14 | 1730.7 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-18C | 1403.8 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-19A | 1619.2 Titers |
| Control Group | Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies | MOPA-19F | 696.4 Titers |
Comparison: Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-1), one month after the administration of Prevnar 13 vaccine dose.95% CI: [0.82, 1.33]ANCOVA
Comparison: Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-3), one month after the administration of Prevnar 13 vaccine dose.95% CI: [0.86, 1.22]ANCOVA
Comparison: Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-4), one month after the administration of Prevnar 13 vaccine dose.95% CI: [1.02, 1.52]ANCOVA
Comparison: Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-5), one month after the administration of Prevnar 13 vaccine dose.95% CI: [0.81, 1.32]ANCOVA
Comparison: Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-6A), one month after the administration of Prevnar 13 vaccine dose.95% CI: [1.02, 1.56]ANCOVA
Comparison: Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-6B), one month after the administration of Prevnar 13 vaccine dose.95% CI: [1.07, 1.73]ANCOVA
Comparison: Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-7F), one month after the administration of Prevnar 13 vaccine dose.95% CI: [1.01, 1.44]ANCOVA
Comparison: Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-9V), one month after the administration of Prevnar 13 vaccine dose.95% CI: [0.97, 1.39]ANCOVA
Comparison: Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-14), one month after the administration of Prevnar 13 vaccine dose.95% CI: [0.94, 1.42]ANCOVA
Comparison: Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-18C), one month after the administration of Prevnar 13 vaccine dose.95% CI: [0.92, 1.34]ANCOVA
Comparison: Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-19A), one month after the administration of Prevnar 13 vaccine dose.95% CI: [0.87, 1.22]ANCOVA
Comparison: Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-19F), one month after the administration of Prevnar 13 vaccine dose.95% CI: [0.9, 1.32]ANCOVA
Comparison: Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-23F), one month after the administration of Prevnar 13 vaccine dose.95% CI: [0.96, 1.5]ANCOVA
Primary
Anti-gE Antibody Concentrations
Anti-gE antibody concentrations in terms of Geometric Mean concentrations (GMC) were determined by ELISA and expressed as milli-international units per milliliter (mIU/mL)
Time frame: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
Population: Analysis was performed on the PPS for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Co-Ad Group | Anti-gE Antibody Concentrations | 54789.9 mlU/mL |
| Control Group | Anti-gE Antibody Concentrations | 59126.7 mlU/mL |
Primary
Anti-pneumococcal Antibody Titers
Anti-pneumococcal antibody titers for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were determined by Multiplex Opsonophagocytosis Assay (MOPA)
Time frame: At one month post-dose 1 (Month 1)
Population: Analysis was performed on the PPS for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-23F | 758.1 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-1 | 144.2 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-3 | 99.8 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-4 | 1127.2 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-5 | 279.4 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-6A | 1839.3 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-6B | 1499.4 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-7F | 1981 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-9V | 2541.9 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-14 | 1752.6 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-18C | 1450.3 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-19A | 1684.9 Titers |
| Co-Ad Group | Anti-pneumococcal Antibody Titers | MOPA-19F | 712 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-18C | 1606.6 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-7F | 2387.5 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-1 | 151.5 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-19F | 802.4 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-3 | 100.2 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-9V | 3049.3 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-4 | 1392.4 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-19A | 1664.3 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-5 | 292.8 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-14 | 2096 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-6A | 2354.9 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-23F | 925.5 Titers |
| Control Group | Anti-pneumococcal Antibody Titers | MOPA-6B | 2025.9 Titers |
Primary
Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group
Vaccine response rate (VRR) for Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) humoral immunogenicity was determined by Enzyme Limked Immunosorbent Assay (ELISA). The VRR for anti-gE is defined as the percentage of subjects who had at least: a 4-fold increase in the anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the anti-gE antibodies concentration as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who are seronegative at baseline.
Time frame: One month post-dose 2 (Month 3)
Population: Analysis was performed on the Per-Protocol Set (PPS) for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Co-Ad Group | Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group | 99.1 Percentage of subjects |
Secondary
Number of Days With Each Solicited Local Symptoms
The number of days with any local symptoms had been assessed during the post-vaccination period.
Time frame: Within 7 days (Day 1 - 7) after each vaccination
Population: Analysis was performed on ES which included all subjects with at least one vaccine administration documented and who provided solicited safety data and for those who experienced the specified symptom for the specific dose.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Co-Ad Group | Number of Days With Each Solicited Local Symptoms | Any pain,Dose1 | 3 Days |
| Co-Ad Group | Number of Days With Each Solicited Local Symptoms | Any swelling, Dose2 | 3 Days |
| Co-Ad Group | Number of Days With Each Solicited Local Symptoms | Any erythema, Dose2 | 3 Days |
| Co-Ad Group | Number of Days With Each Solicited Local Symptoms | Any swelling, Dose1 | 2 Days |
| Co-Ad Group | Number of Days With Each Solicited Local Symptoms | Any pain,Dose2 | 3 Days |
| Co-Ad Group | Number of Days With Each Solicited Local Symptoms | Any erythema,Dose1 | 3 Days |
| Control Group | Number of Days With Each Solicited Local Symptoms | Any swelling, Dose2 | 2 Days |
| Control Group | Number of Days With Each Solicited Local Symptoms | Any erythema,Dose3 | 2 Days |
| Control Group | Number of Days With Each Solicited Local Symptoms | Any pain,Dose3 | 3 Days |
| Control Group | Number of Days With Each Solicited Local Symptoms | Any swelling,Dose3 | 2 Days |
| Control Group | Number of Days With Each Solicited Local Symptoms | Any erythema,Dose1 | 2 Days |
| Control Group | Number of Days With Each Solicited Local Symptoms | Any pain,Dose1 | 2 Days |
| Control Group | Number of Days With Each Solicited Local Symptoms | Any swelling, Dose1 | 2 Days |
| Control Group | Number of Days With Each Solicited Local Symptoms | Any erythema, Dose2 | 2 Days |
| Control Group | Number of Days With Each Solicited Local Symptoms | Any pain,Dose2 | 3 Days |
Secondary
Number of Days With Solicited General Symptoms
The number of days with any general symptoms had been assessed during the post-vaccination period. Assessed solicited general symptoms were fatigue, fever, GastroIntestinal (GI) symptoms, headache, myalgia and shivering.
Time frame: Within 7 days (Day 1 - 7) after each vaccination
Population: Analysis was performed on ES which included all subjects with at least one vaccine administration documented and who provided solicited safety data and for those who experienced the specified symptom for the specific dose.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Co-Ad Group | Number of Days With Solicited General Symptoms | Any GI symptoms,Dose2 | 1 Days |
| Co-Ad Group | Number of Days With Solicited General Symptoms | Any fatigue,Dose1 | 2 Days |
| Co-Ad Group | Number of Days With Solicited General Symptoms | Any headache,Dose2 | 2 Days |
| Co-Ad Group | Number of Days With Solicited General Symptoms | Any shivering,Dose1 | 1 Days |
| Co-Ad Group | Number of Days With Solicited General Symptoms | Any myalgia,Dose2 | 2 Days |
| Co-Ad Group | Number of Days With Solicited General Symptoms | Any headache,Dose1 | 2 Days |
| Co-Ad Group | Number of Days With Solicited General Symptoms | Any shivering,Dose2 | 1 Days |
| Co-Ad Group | Number of Days With Solicited General Symptoms | Any fever,Dose1 | 1 Days |
| Co-Ad Group | Number of Days With Solicited General Symptoms | Any fever,Dose2 | 1 Days |
| Co-Ad Group | Number of Days With Solicited General Symptoms | Any GI symptoms,Dose1 | 2 Days |
| Co-Ad Group | Number of Days With Solicited General Symptoms | Any fatigue,Dose2 | 2 Days |
| Co-Ad Group | Number of Days With Solicited General Symptoms | Any myalgia,Dose1 | 2 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any headache,Dose2 | 2 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any myalgia,Dose2 | 2 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any shivering,Dose2 | 1 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any fever,Dose2 | 1 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any GI symptoms,Dose3 | 1 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any fatigue,Dose3 | 2 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any headache,Dose3 | 1.5 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any myalgia,Dose3 | 2 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any shivering,Dose3 | 1 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any fever,Dose3 | 1 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any fatigue,Dose1 | 2 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any GI symptoms,Dose1 | 1 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any headache,Dose1 | 1 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any myalgia,Dose1 | 2 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any shivering,Dose1 | 1 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any fever,Dose1 | 1 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any fatigue,Dose2 | 2 Days |
| Control Group | Number of Days With Solicited General Symptoms | Any GI symptoms,Dose2 | 1 Days |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose
Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 erythema/swelling = erythema/swelling that had spread beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.
Time frame: Within 7 days (Day 1 - 7) after each vaccination
Population: Analysis was performed on Exposed Set (ES) which included all subjects with at least one vaccine administration documented and who provided solicited safety data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Erythema, Dose1 | 131 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Erythema, Dose1 | 7 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Pain, Dose1 | 347 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Pain, Dose1 | 28 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Swelling, Dose1 | 76 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Swelling, Dose1 | 1 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Erythema, Dose2 | 147 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Erythema, Dose2 | 9 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Pain, Dose2 | 326 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Pain, Dose2 | 28 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Swelling, Dose2 | 70 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Swelling, Dose2 | 1 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Erythema, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Erythema, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Pain, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Pain, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Swelling, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Swelling, Dose3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Erythema, Dose3 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Erythema, Dose1 | 31 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Pain, Dose2 | 32 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Erythema, Dose1 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Swelling, Dose3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Pain, Dose1 | 241 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Swelling, Dose2 | 72 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Pain, Dose1 | 9 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Pain, Dose3 | 350 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Swelling, Dose1 | 21 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Swelling, Dose2 | 2 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Swelling, Dose1 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Swelling, Dose3 | 60 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Erythema, Dose2 | 128 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Erythema, Dose3 | 123 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Erythema, Dose2 | 5 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Grade3 Pain, Dose3 | 41 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose | Any Pain, Dose2 | 359 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose
Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 erythema/swelling = erythema/swelling that had spread beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.
Time frame: Within 7 days (Day 1 - 7) after each vaccination
Population: Analysis was performed on Exposed Set (ES) which included all subjects with at least one vaccine administration documented and who provided solicited safety data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Pain, Prevenar13, Dose1 | 233 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Erythema, GSK1437173A, Dose1 | 5 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Erythema, Prevenar13, Dose1 | 48 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Erythema, Prevenar13, Dose1 | 2 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Pain, GSK1437173A, Dose1 | 332 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Pain, GSK1437173A, Dose1 | 25 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Erythema, GSK1437173A, Dose1 | 120 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Pain, Prevenar13, Dose1 | 11 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Swelling, GSK1437173A, Dose1 | 69 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Swelling, GSK1437173A, Dose1 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Swelling, Prevenar13, Dose1 | 33 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Swelling, Prevenar13, Dose1 | 1 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Erythema, GSK1437173A, Dose2 | 147 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Erythema, GSK1437173A, Dose2 | 9 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Pain, GSK1437173A, Dose2 | 326 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Pain, GSK1437173A, Dose2 | 28 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Swelling, GSK1437173A, Dose2 | 70 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Swelling, GSK1437173A, Dose2 | 1 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Erythema, GSK1437173A, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Erythema, GSK1437173A, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Pain, GSK1437173A, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Pain, GSK1437173A, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Swelling, GSK1437173A, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Swelling, GSK1437173A, Dose3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Swelling, GSK1437173A, Dose3 | 60 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Erythema, GSK1437173A, Dose1 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Erythema, GSK1437173A, Dose2 | 128 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Erythema, GSK1437173A, Dose1 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Erythema, GSK1437173A, Dose3 | 123 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Erythema, Prevenar13, Dose1 | 31 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Erythema, GSK1437173A, Dose2 | 5 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Erythema, Prevenar13, Dose1 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Pain, GSK1437173A, Dose3 | 41 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Pain, GSK1437173A, Dose1 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Pain, GSK1437173A, Dose2 | 359 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Pain, GSK1437173A, Dose1 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Erythema, GSK1437173A, Dose3 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Pain, Prevenar13, Dose1 | 241 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Pain, GSK1437173A, Dose2 | 32 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Pain, Prevenar13, Dose1 | 9 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Swelling, GSK1437173A, Dose3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Swelling, GSK1437173A, Dose1 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Swelling, GSK1437173A, Dose2 | 72 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Swelling, GSK1437173A, Dose1 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Pain, GSK1437173A, Dose3 | 350 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Any Swelling, Prevenar13, Dose1 | 21 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Swelling, GSK1437173A, Dose2 | 2 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose | Grade3 Swelling, Prevenar13, Dose1 | 0 Participants |
Secondary
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) From Day 1 to 30 Days Post Last Vaccination
pIMDs assessed were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not had an autoimmune aetiology. Related pIMDs= pIMDs assessed by the investigator as causally related to the study vaccination.
Time frame: From first vaccination at Day 1 up to 30 days post last vaccination.
Population: Analysis was performed on ES which included all subjects with at least one vaccine administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Ad Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) From Day 1 to 30 Days Post Last Vaccination | Subjects with any pIMDs | 1 Participants |
| Co-Ad Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) From Day 1 to 30 Days Post Last Vaccination | Subjects with related pIMDs | 0 Participants |
| Control Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) From Day 1 to 30 Days Post Last Vaccination | Subjects with any pIMDs | 1 Participants |
| Control Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) From Day 1 to 30 Days Post Last Vaccination | Subjects with related pIMDs | 0 Participants |
Secondary
Number of Subjects With Any and Related SAEs From 30 Days Post Last Vaccination up to Study End.
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= SAEs assessed by the investigator as causally related to the study vaccination.
Time frame: From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)
Population: Analysis was performed on ES which included all subjects with at least one vaccine administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Ad Group | Number of Subjects With Any and Related SAEs From 30 Days Post Last Vaccination up to Study End. | Subjects with any SAEs | 10 Participants |
| Co-Ad Group | Number of Subjects With Any and Related SAEs From 30 Days Post Last Vaccination up to Study End. | Subjects with related SAEs | 0 Participants |
| Control Group | Number of Subjects With Any and Related SAEs From 30 Days Post Last Vaccination up to Study End. | Subjects with any SAEs | 10 Participants |
| Control Group | Number of Subjects With Any and Related SAEs From 30 Days Post Last Vaccination up to Study End. | Subjects with related SAEs | 0 Participants |
Secondary
Number of Subjects With Any and Related Serious Adverse Events (SAE) From Day 1 to 30 Days Post Last Vaccination
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= SAEs assessed by the investigator as causally related to the study vaccination.
Time frame: From first vaccination at Day 1 up to 30 days post last vaccination
Population: Analysis was performed on ES which included all subjects with at least one vaccine administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Ad Group | Number of Subjects With Any and Related Serious Adverse Events (SAE) From Day 1 to 30 Days Post Last Vaccination | Subjects with any SAEs | 7 Participants |
| Co-Ad Group | Number of Subjects With Any and Related Serious Adverse Events (SAE) From Day 1 to 30 Days Post Last Vaccination | Subjects with related SAEs | 0 Participants |
| Control Group | Number of Subjects With Any and Related Serious Adverse Events (SAE) From Day 1 to 30 Days Post Last Vaccination | Subjects with any SAEs | 8 Participants |
| Control Group | Number of Subjects With Any and Related Serious Adverse Events (SAE) From Day 1 to 30 Days Post Last Vaccination | Subjects with related SAEs | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, fever \[defined as oral temperature ≥ 38.0 degrees Celsius (°C)/ 100.4 degrees Fahrenheit (°F)\], GastroIntestinal (GI) symptoms, headache, myalgia and shivering. 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: Within 7 days (Day 1 - 7) after each vaccination
Population: Analysis was performed on ES which included all subjects with at least one vaccine administration documented and who provided solicited safety data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose2 | 156 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose1 | 150 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Headache, Dose2 | 18 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Fever, Dose1 | 1 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose2 | 143 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose1 | 78 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose2 | 203 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related GI symptoms, Dose1 | 55 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Myalgia, Dose2 | 23 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Shivering, Dose1 | 9 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose2 | 186 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Fatigue, Dose1 | 21 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose2 | 95 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose1 | 71 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Shivering, Dose2 | 12 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose1 | 130 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose2 | 86 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose2 | 192 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose1 | 8 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Fatigue, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Fatigue, Dose2 | 22 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Headache, Dose1 | 10 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose2 | 177 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Fever, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose1 | 10 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose2 | 16 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any GI symptoms, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose1 | 113 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 GI symptoms, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Fever, Dose2 | 2 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related GI symptoms, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any GI symptoms, Dose1 | 61 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose2 | 10 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Headache, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose1 | 168 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any GI symptoms, Dose2 | 57 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose1 | 149 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Myalgia, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 GI symptoms, Dose2 | 8 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Myalgia, Dose1 | 17 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related GI symptoms, Dose2 | 50 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Shivering, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 GI symptoms, Dose1 | 6 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose3 | 0 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose1 | 166 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose3 | 117 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose1 | 85 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Fatigue, Dose1 | 5 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose1 | 67 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose1 | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Fever, Dose1 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose1 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any GI symptoms, Dose1 | 37 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 GI symptoms, Dose1 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related GI symptoms, Dose1 | 30 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose1 | 72 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Headache, Dose1 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose1 | 59 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose1 | 102 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Myalgia, Dose1 | 4 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose1 | 86 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose1 | 7 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Shivering, Dose1 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose1 | 7 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose2 | 152 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Fatigue, Dose2 | 17 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose2 | 141 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose2 | 7 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Fever, Dose2 | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose2 | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any GI symptoms, Dose2 | 47 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 GI symptoms, Dose2 | 4 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related GI symptoms, Dose2 | 44 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose2 | 115 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Headache, Dose2 | 7 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose2 | 99 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose2 | 174 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Myalgia, Dose2 | 24 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose2 | 163 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose2 | 50 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Shivering, Dose2 | 8 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose2 | 47 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose3 | 210 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Fatigue, Dose3 | 27 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose3 | 202 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose3 | 23 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Fever, Dose3 | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose3 | 17 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any GI symptoms, Dose3 | 69 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 GI symptoms, Dose3 | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related GI symptoms, Dose3 | 63 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose3 | 180 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Headache, Dose3 | 23 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose3 | 168 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose3 | 224 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Myalgia, Dose3 | 37 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose3 | 215 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose3 | 122 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade3 Shivering, Dose3 | 20 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE)
An unsolicited AE covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: Within 30 days (Day 1 to 30) after each vaccination
Population: Analysis was performed on ES which included all subjects with at least one vaccine administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE) | Subjects with any AEs | 95 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE) | Subjects with Grade 3 AEs | 9 Participants |
| Co-Ad Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE) | Subjects with related AEs | 35 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE) | Subjects with any AEs | 107 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE) | Subjects with Grade 3 AEs | 13 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE) | Subjects with related AEs | 25 Participants |
Secondary
Number of Subjects With Any pIMDs From 30 Days Post Last Vaccination up to Study End.
pIMDs assessed were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not had an autoimmune aetiology.
Time frame: From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)
Population: Analysis was performed on ES which included all subjects with at least one vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Co-Ad Group | Number of Subjects With Any pIMDs From 30 Days Post Last Vaccination up to Study End. | 1 Participants |
| Control Group | Number of Subjects With Any pIMDs From 30 Days Post Last Vaccination up to Study End. | 0 Participants |