Influenza, Influenza Vaccines
Conditions
Keywords
prophylaxis of pandemic influenza
Brief summary
Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world. Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have been directly transmitted to humans, raising concern over the possibility of a new influenza pandemic among the world's immunologically naive populations. In order to face this kind of situation, a pandemic influenza vaccine has to be developed.
Interventions
BIOLOGICALSB218352_15
Non-adjuvanted pandemic influenza A formulation 1 vaccine
BIOLOGICALSB218352_8
Non-adjuvanted pandemic influenza A formulation 2 vaccine
BIOLOGICALSB218352_4
Non-adjuvanted pandemic influenza A formulation 3 vaccine
BIOLOGICALSB218352_2
Non-adjuvanted pandemic influenza A formulation 4 vaccine
BIOLOGICALSB218352_8AL
Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine
BIOLOGICALSB218352_4AL
Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine
BIOLOGICALSB218352_2AL
Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol * A male or female aged over 60 years at the time of vaccination. * Written informed consent obtained from the subject.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period. * Participation in an earlier study with a candidate pandemic H9N2 vaccine. * Acute disease at the time of enrolment. * Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Drug and/or alcohol dependency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | At Day 10 post Dose 1 | Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs). |
| Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | At Day 21 post Dose 1 | Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs). |
| Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | At Day 10 post Dose 1 | Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer lower than (\<) 1:10 and a post-vaccination titre higher than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer |
| Seroconversion Factor for Influenza A Subtype H9N2 | At Day 10 post Dose 1 | Seroconversion factor was defined as the fold increase in serum HI GMTs on day 10 compared to day 0. |
| Number of Seroprotected Subjects Against H9N2 | At Day 10 post Dose 1 | Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection. |
| Number of Subjects With Seroprotection Power Against H9N2 | At Day 10 post Dose 1 | Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | At Days 0, 10, 21 and 42 post-vaccination | Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L). |
| Frequency of Antigen-specific CD8 T-cells | At Days 0, 10, 21 and 42 post-vaccination | Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). |
| Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | At Days 189 and 365 | SCF was defined as the fold increase in serum HI GMTs at the post-vaccination time points compared to Day 0, for each vaccine strain. |
| Cytokine-positive CD8 T-cells Frequency | At Days 10, 21 and 42 post-vaccination | Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0. |
| Number of Subjects With Antibody Persistence | At Days 189 and 365 | Antibody persistence was evaluated in terms of seroprotection rate (SPR) against influenza A subtype H9N2 and seroconversion rate (SCR) against influenza A subtype H9N2. |
| Number of Subjects With Solicited General Symptoms | During the 4-days (Day 0-3) post Dose 1 | Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination. |
| Number of Subjects With Unsolicited AEs | During the 30-days post Dose 3 (Days 189-219 for Subset 1 groups and Days 365-395 for Subset 2 groups) | 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. |
| Number of Subjects With SAEs | Within the 365-day post-vaccination period (Days 0-364 for Subset 1 groups) and within the 395-day post-vaccination period (Days 0-394 for Subset 2 groups) | A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). |
| Number of Subjects With Any SAEs | Up to 30-day post Dose 3 (Days 365-394) | A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). Only Subset 2 groups had available data for the specified time frame. |
| Number of Subjects With Solicited Local Symptoms | During the 4-days post Dose 1 (Days 0-3), post Dose 2 (Days 21-24) and across these doses | Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm). |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 30-days (Day 0-30) post vaccination | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 to Day 51 | A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). |
| Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | At Days 0, 10, 21 and 42 post vaccination | Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L). |
| Frequency of Antigen-specific CD4 T-cells | At Days 0, 10, 21 and 42 post-vaccination | Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). |
| Cytokine-positive CD4 T-cells Frequency | At Days 10, 21 and 42 post-vaccination | Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0. |
Countries
Germany
Participant flow
Pre-assignment details
After Part I, the core study (study period from Visit 1 on Day 0 up to the phone contact on Day 51), the enrolled subjects were stratified into Subset 1 (Part II - Visit 5 on Day 189 to study conclusion, i.e ., Visit 7 on Day 365) or Subset 2 (Part II - Visit 6 on Day 365 to study conclusion, i.e ., phone contact on Day 395).
Participants by arm
| Arm | Count |
|---|---|
| SB218352_15 Group: Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. | 55 |
| SB218352_8 Group: Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. | 55 |
| SB218352_4 Group: Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. | 55 |
| SB218352_2 Group: Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. | 55 |
| SB218352_8AL Group: Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. | 55 |
| SB218352_4AL Group: Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. | 55 |
| SB218352_2AL Group: Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2. | 55 |
| Total | 385 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Study Part I | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Study Part II for Subset 2 | Serious Adverse Event | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | SB218352_15 Group: | SB218352_8 Group: | SB218352_4 Group: | SB218352_2 Group: | SB218352_8AL Group: | SB218352_4AL Group: | SB218352_2AL Group: | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 68.4 Years STANDARD_DEVIATION 5.11 | 69.0 Years STANDARD_DEVIATION 5.66 | 69.2 Years STANDARD_DEVIATION 5.77 | 69.1 Years STANDARD_DEVIATION 5.94 | 68.4 Years STANDARD_DEVIATION 5.92 | 68.4 Years STANDARD_DEVIATION 6.31 | 69.8 Years STANDARD_DEVIATION 5.91 | 68.9 Years STANDARD_DEVIATION 5.8 |
| Race/Ethnicity, Customized Arabic/North African | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White-Caucasian | 55 Participants | 55 Participants | 55 Participants | 54 Participants | 55 Participants | 55 Participants | 55 Participants | 384 Participants |
| Sex: Female, Male Female | 28 Participants | 31 Participants | 30 Participants | 32 Participants | 28 Participants | 41 Participants | 22 Participants | 212 Participants |
| Sex: Female, Male Male | 27 Participants | 24 Participants | 25 Participants | 23 Participants | 27 Participants | 14 Participants | 33 Participants | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 | 0 / 55 | 0 / 55 | 0 / 55 | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 26 / 55 | 16 / 55 | 25 / 55 | 14 / 55 | 28 / 55 | 22 / 55 | 24 / 55 |
| serious Total, serious adverse events | 1 / 55 | 0 / 55 | 1 / 55 | 0 / 55 | 0 / 55 | 0 / 55 | 1 / 55 |
Outcome results
Primary
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in postvaccination titer
Time frame: At Day 21 post Dose 2 (Day 42)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB218352_15 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 31 Participants |
| SB218352_8 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 22 Participants |
| SB218352_4 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 22 Participants |
| SB218352_2 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 11 Participants |
| SB218352_8AL Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 28 Participants |
| SB218352_4AL Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 22 Participants |
| SB218352_2AL Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 16 Participants |
Primary
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer lower than (\<) 1:10 and a post-vaccination titre higher than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer
Time frame: At Day 10 post Dose 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB218352_15 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 12 Participants |
| SB218352_8 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 11 Participants |
| SB218352_4 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 11 Participants |
| SB218352_2 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 1 Participants |
| SB218352_8AL Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 14 Participants |
| SB218352_4AL Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 10 Participants |
| SB218352_2AL Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 8 Participants |
Primary
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer
Time frame: At Day 21 post Dose 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB218352_15 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 19 Participants |
| SB218352_8 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 17 Participants |
| SB218352_4 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 13 Participants |
| SB218352_2 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 3 Participants |
| SB218352_8AL Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 20 Participants |
| SB218352_4AL Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 10 Participants |
| SB218352_2AL Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 10 Participants |
Primary
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer
Time frame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB218352_15 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 15 Participants |
| SB218352_8 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 18 Participants |
| SB218352_4 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 19 Participants |
| SB218352_2 Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 13 Participants |
| SB218352_8AL Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 20 Participants |
| SB218352_4AL Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 15 Participants |
| SB218352_2AL Group: | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 10 Participants |
| SB218352_15 Subset 2 | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 19 Participants |
| SB218352_8 Subset 2 | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 10 Participants |
| SB218352_4 Subset 2 | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 12 Participants |
| SB218352_2 Subset 2 | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 4 Participants |
| SB218352_8AL Subset 2 | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 17 Participants |
| SB218352_4AL Subset 2 | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 15 Participants |
| SB218352_2AL Subset 2 | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | 14 Participants |
Primary
Number of Seroprotected Subjects Against H9N2
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Time frame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB218352_15 Group: | Number of Seroprotected Subjects Against H9N2 | 18 Participants |
| SB218352_8 Group: | Number of Seroprotected Subjects Against H9N2 | 18 Participants |
| SB218352_4 Group: | Number of Seroprotected Subjects Against H9N2 | 21 Participants |
| SB218352_2 Group: | Number of Seroprotected Subjects Against H9N2 | 17 Participants |
| SB218352_8AL Group: | Number of Seroprotected Subjects Against H9N2 | 22 Participants |
| SB218352_4AL Group: | Number of Seroprotected Subjects Against H9N2 | 18 Participants |
| SB218352_2AL Group: | Number of Seroprotected Subjects Against H9N2 | 11 Participants |
| SB218352_15 Subset 2 | Number of Seroprotected Subjects Against H9N2 | 20 Participants |
| SB218352_8 Subset 2 | Number of Seroprotected Subjects Against H9N2 | 13 Participants |
| SB218352_4 Subset 2 | Number of Seroprotected Subjects Against H9N2 | 13 Participants |
| SB218352_2 Subset 2 | Number of Seroprotected Subjects Against H9N2 | 6 Participants |
| SB218352_8AL Subset 2 | Number of Seroprotected Subjects Against H9N2 | 20 Participants |
| SB218352_4AL Subset 2 | Number of Seroprotected Subjects Against H9N2 | 17 Participants |
| SB218352_2AL Subset 2 | Number of Seroprotected Subjects Against H9N2 | 16 Participants |
Primary
Number of Seroprotected Subjects Against H9N2
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Time frame: At Day 21 post Dose 2 (Day 42)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB218352_15 Group: | Number of Seroprotected Subjects Against H9N2 | 41 Participants |
| SB218352_8 Group: | Number of Seroprotected Subjects Against H9N2 | 27 Participants |
| SB218352_4 Group: | Number of Seroprotected Subjects Against H9N2 | 27 Participants |
| SB218352_2 Group: | Number of Seroprotected Subjects Against H9N2 | 14 Participants |
| SB218352_8AL Group: | Number of Seroprotected Subjects Against H9N2 | 35 Participants |
| SB218352_4AL Group: | Number of Seroprotected Subjects Against H9N2 | 25 Participants |
| SB218352_2AL Group: | Number of Seroprotected Subjects Against H9N2 | 19 Participants |
Primary
Number of Seroprotected Subjects Against H9N2
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Time frame: At Day 10 post Dose 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB218352_15 Group: | Number of Seroprotected Subjects Against H9N2 | 19 Participants |
| SB218352_8 Group: | Number of Seroprotected Subjects Against H9N2 | 13 Participants |
| SB218352_4 Group: | Number of Seroprotected Subjects Against H9N2 | 14 Participants |
| SB218352_2 Group: | Number of Seroprotected Subjects Against H9N2 | 6 Participants |
| SB218352_8AL Group: | Number of Seroprotected Subjects Against H9N2 | 20 Participants |
| SB218352_4AL Group: | Number of Seroprotected Subjects Against H9N2 | 16 Participants |
| SB218352_2AL Group: | Number of Seroprotected Subjects Against H9N2 | 11 Participants |
Primary
Number of Seroprotected Subjects Against H9N2
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Time frame: At Day 21 post Dose 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB218352_15 Group: | Number of Seroprotected Subjects Against H9N2 | 24 Participants |
| SB218352_8 Group: | Number of Seroprotected Subjects Against H9N2 | 19 Participants |
| SB218352_4 Group: | Number of Seroprotected Subjects Against H9N2 | 16 Participants |
| SB218352_2 Group: | Number of Seroprotected Subjects Against H9N2 | 7 Participants |
| SB218352_8AL Group: | Number of Seroprotected Subjects Against H9N2 | 27 Participants |
| SB218352_4AL Group: | Number of Seroprotected Subjects Against H9N2 | 15 Participants |
| SB218352_2AL Group: | Number of Seroprotected Subjects Against H9N2 | 13 Participants |
Primary
Number of Subjects With Seroprotection Power Against H9N2
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Time frame: At Day 10 post Dose 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB218352_15 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 4 Participants |
| SB218352_8 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 4 Participants |
| SB218352_4 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 6 Participants |
| SB218352_2 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 2 Participants |
| SB218352_8AL Group: | Number of Subjects With Seroprotection Power Against H9N2 | 5 Participants |
| SB218352_4AL Group: | Number of Subjects With Seroprotection Power Against H9N2 | 7 Participants |
| SB218352_2AL Group: | Number of Subjects With Seroprotection Power Against H9N2 | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 8 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 7 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 4 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 10 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 7 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 7 Participants |
Primary
Number of Subjects With Seroprotection Power Against H9N2
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Time frame: At Day 21 post Dose 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB218352_15 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 7 Participants |
| SB218352_8 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 9 Participants |
| SB218352_4 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 8 Participants |
| SB218352_2 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 3 Participants |
| SB218352_8AL Group: | Number of Subjects With Seroprotection Power Against H9N2 | 8 Participants |
| SB218352_4AL Group: | Number of Subjects With Seroprotection Power Against H9N2 | 7 Participants |
| SB218352_2AL Group: | Number of Subjects With Seroprotection Power Against H9N2 | 1 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 9 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 8 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 4 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 12 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 6 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 8 Participants |
Primary
Number of Subjects With Seroprotection Power Against H9N2
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Time frame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB218352_15 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 13 Participants |
| SB218352_8 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 17 Participants |
| SB218352_4 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 20 Participants |
| SB218352_2 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 15 Participants |
| SB218352_8AL Group: | Number of Subjects With Seroprotection Power Against H9N2 | 21 Participants |
| SB218352_4AL Group: | Number of Subjects With Seroprotection Power Against H9N2 | 18 Participants |
| SB218352_2AL Group: | Number of Subjects With Seroprotection Power Against H9N2 | 11 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 20 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 12 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 11 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 4 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 17 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 16 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 15 Participants |
Primary
Number of Subjects With Seroprotection Power Against H9N2
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Time frame: At Day 21 post Dose 2 (Day 42)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB218352_15 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 13 Participants |
| SB218352_8 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 12 Participants |
| SB218352_4 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 14 Participants |
| SB218352_2 Group: | Number of Subjects With Seroprotection Power Against H9N2 | 9 Participants |
| SB218352_8AL Group: | Number of Subjects With Seroprotection Power Against H9N2 | 13 Participants |
| SB218352_4AL Group: | Number of Subjects With Seroprotection Power Against H9N2 | 12 Participants |
| SB218352_2AL Group: | Number of Subjects With Seroprotection Power Against H9N2 | 4 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 17 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 12 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 7 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 1 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 14 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 9 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Seroprotection Power Against H9N2 | 10 Participants |
Primary
Seroconversion Factor for Influenza A Subtype H9N2
Seroconversion factor defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 42) compared to day 0.
Time frame: At Day 21 post Dose 2 (Day 42)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| SB218352_15 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 6.3 Fold change |
| SB218352_8 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 4.9 Fold change |
| SB218352_4 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 4.3 Fold change |
| SB218352_2 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 2.9 Fold change |
| SB218352_8AL Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 8.3 Fold change |
| SB218352_4AL Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 4.9 Fold change |
| SB218352_2AL Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 3.7 Fold change |
Primary
Seroconversion Factor for Influenza A Subtype H9N2
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 compared to day 0.
Time frame: At Day 21 post Dose 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| SB218352_15 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 3.6 Fold change |
| SB218352_8 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 2.7 Fold change |
| SB218352_4 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 3.0 Fold change |
| SB218352_2 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 1.7 Fold change |
| SB218352_8AL Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 5.5 Fold change |
| SB218352_4AL Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 2.6 Fold change |
| SB218352_2AL Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 2.5 Fold change |
Primary
Seroconversion Factor for Influenza A Subtype H9N2
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 210 for Subset 1 and Day 386 for Subset 2) compared to day 0.
Time frame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SB218352_15 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 5.4 Fold change |
| SB218352_8 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 8.3 Fold change |
| SB218352_4 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 7.9 Fold change |
| SB218352_2 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 4.4 Fold change |
| SB218352_8AL Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 10.5 Fold change |
| SB218352_4AL Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 6.4 Fold change |
| SB218352_2AL Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 4.3 Fold change |
| SB218352_15 Subset 2 | Seroconversion Factor for Influenza A Subtype H9N2 | 11.9 Fold change |
| SB218352_8 Subset 2 | Seroconversion Factor for Influenza A Subtype H9N2 | 5.5 Fold change |
| SB218352_4 Subset 2 | Seroconversion Factor for Influenza A Subtype H9N2 | 5.6 Fold change |
| SB218352_2 Subset 2 | Seroconversion Factor for Influenza A Subtype H9N2 | 2.8 Fold change |
| SB218352_8AL Subset 2 | Seroconversion Factor for Influenza A Subtype H9N2 | 11.2 Fold change |
| SB218352_4AL Subset 2 | Seroconversion Factor for Influenza A Subtype H9N2 | 2.0 Fold change |
| SB218352_2AL Subset 2 | Seroconversion Factor for Influenza A Subtype H9N2 | 5.4 Fold change |
Primary
Seroconversion Factor for Influenza A Subtype H9N2
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 10 compared to day 0.
Time frame: At Day 10 post Dose 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| SB218352_15 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 2.7 Fold change |
| SB218352_8 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 2.1 Fold change |
| SB218352_4 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 2.0 Fold change |
| SB218352_2 Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 1.4 Fold change |
| SB218352_8AL Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 3.1 Fold change |
| SB218352_4AL Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 2.4 Fold change |
| SB218352_2AL Group: | Seroconversion Factor for Influenza A Subtype H9N2 | 2.4 Fold change |
Primary
Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Time frame: At Day 10 post Dose 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| SB218352_15 Group: | Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 24.4 Titer |
| SB218352_8 Group: | Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 15.6 Titer |
| SB218352_4 Group: | Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 14.6 Titer |
| SB218352_2 Group: | Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 9.8 Titer |
| SB218352_8AL Group: | Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 23.3 Titer |
| SB218352_4AL Group: | Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 18.8 Titer |
| SB218352_2AL Group: | Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 16.9 Titer |
Primary
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Time frame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| SB218352_15 Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 49.5 Titers |
| SB218352_8 Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 51.3 Titers |
| SB218352_4 Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 51.1 Titers |
| SB218352_2 Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 32.2 Titers |
| SB218352_8AL Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 71.0 Titers |
| SB218352_4AL Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 44.0 Titers |
| SB218352_2AL Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 28.3 Titers |
| SB218352_15 Subset 2 | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 103.0 Titers |
| SB218352_8 Subset 2 | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 41.3 Titers |
| SB218352_4 Subset 2 | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 41.9 Titers |
| SB218352_2 Subset 2 | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 21.4 Titers |
| SB218352_8AL Subset 2 | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 108.1 Titers |
| SB218352_4AL Subset 2 | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 62.5 Titers |
| SB218352_2AL Subset 2 | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 54.9 Titers |
Primary
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Time frame: At Day 21 post Dose 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| SB218352_15 Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 32.5 Titers |
| SB218352_8 Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 20.1 Titers |
| SB218352_4 Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 21.9 Titers |
| SB218352_2 Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 12.0 Titers |
| SB218352_8AL Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 42.1 Titers |
| SB218352_4AL Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 20.0 Titers |
| SB218352_2AL Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 17.8 Titers |
Primary
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Time frame: At Day 21 post Dose 2 (Day 42)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| SB218352_15 Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 55.9 Titers |
| SB218352_8 Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 36.0 Titers |
| SB218352_4 Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 31.0 Titers |
| SB218352_2 Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 20.0 Titers |
| SB218352_8AL Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 63.1 Titers |
| SB218352_4AL Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 38.0 Titers |
| SB218352_2AL Group: | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | 26.0 Titers |
Secondary
Cytokine-positive CD4 T-cells Frequency
Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0.
Time frame: At Days 10, 21 and 42 post-vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 21 | 107.00 CD4+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 42 | 228.00 CD4+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 42 | 291.50 CD4+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 21 | 293.00 CD4+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 21 | 248.00 CD4+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 10 | 295.00 CD4+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 10 | 324.00 CD4+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL-2, DAY 42 | 363.50 CD4+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 42 | 384.00 CD4+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL2, DAY 21 | 227.00 CD4+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL-2, DAY 10 | 226.00 CD4+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 10 | 302.00 CD4+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 10 | 105.00 CD4+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 42 | 125.00 CD4+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 21 | 195.00 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 21 | 120.00 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 21 | 429.50 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 42 | 157.00 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 10 | 134.50 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 42 | 320.00 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 42 | 145.00 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 42 | 360.00 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 21 | 282.50 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 10 | 326.00 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL2, DAY 21 | 401.00 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 21 | 477.00 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 10 | 299.50 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 10 | 221.50 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL-2, DAY 10 | 289.50 CD4+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL-2, DAY 42 | 285.00 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL-2, DAY 10 | 152.00 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 10 | 219.00 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 21 | 359.00 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 42 | 482.50 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 10 | 149.50 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 21 | 271.00 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 42 | 440.00 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 10 | 172.50 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 42 | 124.00 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 21 | 205.00 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL2, DAY 21 | 297.00 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL-2, DAY 42 | 294.50 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 10 | 194.00 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 21 | 259.00 CD4+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 42 | 175.00 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 21 | 252.50 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 10 | 78.50 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 21 | 77.50 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 42 | 239.00 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 21 | 237.00 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 21 | 142.50 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL-2, DAY 10 | 225.00 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 42 | 451.00 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL-2, DAY 42 | 359.00 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 10 | 303.50 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 42 | 136.00 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 42 | 441.00 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 10 | 122.00 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL2, DAY 21 | 117.00 CD4+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 10 | 342.00 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL2, DAY 21 | 400.50 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 42 | 454.00 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL-2, DAY 42 | 648.00 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 21 | 645.00 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 21 | 145.50 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 10 | 384.50 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 42 | 320.00 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 42 | 685.00 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 21 | 630.00 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 21 | 470.50 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 10 | 434.50 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL-2, DAY 10 | 369.50 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 10 | 167.00 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 10 | 210.50 CD4+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 42 | 689.00 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL-2, DAY 42 | 523.00 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 10 | 165.00 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 10 | 335.00 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 21 | 229.00 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 42 | 186.00 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 42 | 554.00 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL-2, DAY 10 | 242.00 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL2, DAY 21 | 518.00 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 21 | 440.50 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 10 | 194.00 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 10 | 398.00 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 42 | 313.00 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 21 | 433.00 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 21 | 156.50 CD4+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 42 | 513.00 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 10 | 140.50 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 10 | 139.00 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 21 | 150.00 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 10 | 104.50 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 42 | 445.00 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 42 | 445.50 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-CD40L, DAY 21 | 286.00 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 21 | 229.00 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 42 | 233.50 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL-2, DAY 42 | 493.00 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-ALL DOUBLES, DAY 21 | 283.00 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL2, DAY 21 | 257.00 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-TNF-α, DAY 42 | 252.50 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IL-2, DAY 10 | 158.50 CD4+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD4 T-cells Frequency | CD4-IFN-γ, DAY 10 | 72.50 CD4+ T-cells/million cells |
Secondary
Cytokine-positive CD8 T-cells Frequency
Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0.
Time frame: At Days 10, 21 and 42 post-vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 10 | -1.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 21 | -46.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 42 | -69.50 CD8+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 10 | 2.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 42 | -0.50 CD8+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 42 | -50.50 CD8+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 21 | -10.50 CD8+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 10 | 4.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 21 | -28.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 21 | -6.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 42 | 44.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 42 | 48.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 10 | -35.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 42 | 74.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 10 | 16.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 21 | -31.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 42 | -29.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 42 | 49.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 10 | 2.50 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 21 | -1.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 10 | 23.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 21 | -7.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 42 | 14.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 42 | 2.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 42 | -50.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 42 | -5.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 10 | -3.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 42 | 46.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 10 | -24.50 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 10 | 4.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 21 | -24.50 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 42 | 99.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 42 | 94.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 10 | 24.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 42 | -1.50 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 42 | 0.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-CD40L, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-ALL DOUBLES, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IFN-γ, DAY 10 | 0.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-TNF-α, DAY 42 | 24.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 21 | 0.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Cytokine-positive CD8 T-cells Frequency | CD8-IL-2, DAY 10 | 0.00 CD8+ T-cells/million cells |
Secondary
Frequency of Antigen-specific CD4 T-cells
Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
Time frame: At Days 0, 10, 21 and 42 post-vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB218352_15 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 10 | 817.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 10 | 751.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 21 | 923.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 21 | 888.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 0 | 414.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 42 | 913.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 0 | 380.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 42 | 868.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 42 | 876.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 21 | 842.50 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 42 | 899.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 10 | 822.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 10 | 985.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 21 | 1013.50 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 0 | 470.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 0 | 491.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 10 | 814.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 42 | 714.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 21 | 814.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 0 | 524.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 42 | 608.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 0 | 495.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 10 | 717.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 21 | 870.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 10 | 522.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 0 | 381.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 10 | 579.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 42 | 717.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 21 | 625.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 42 | 761.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 0 | 337.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 21 | 491.50 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 10 | 924.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 0 | 509.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 0 | 538.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 21 | 1244.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 10 | 728.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 42 | 1079.50 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 42 | 1233.50 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 21 | 988.00 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 0 | 495.50 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 0 | 487.50 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 10 | 821.00 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 21 | 799.00 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 42 | 953.00 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 10 | 793.00 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 21 | 650.50 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 42 | 829.00 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 21 | 672.50 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 42 | 722.00 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 42 | 890.00 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 21 | 764.00 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 10 | 622.00 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-IL-2, DAY 0 | 437.00 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 10 | 641.00 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD4 T-cells | CD4-TNF-α, DAY 0 | 395.00 T-cells/million cells |
Secondary
Frequency of Antigen-specific CD8 T-cells
Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
Time frame: At Days 0, 10, 21 and 42 post-vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB218352_15 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 21 | 1.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 10 | 27.50 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, Day 0 | 52.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 42 | 49.50 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, Day 0 | 60.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 10 | 107.50 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 21 | 75.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 42 | 29.50 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 10 | 1.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 42 | 101.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 21 | 19.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 42 | 1.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, Day 0 | 19.50 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 10 | 25.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 21 | 51.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, Day 0 | 20.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 21 | 1.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 42 | 157.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 42 | 98.50 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, Day 0 | 51.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 10 | 77.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 21 | 57.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 10 | 50.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, Day 0 | 56.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 42 | 24.50 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 42 | 76.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, Day 0 | 50.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 10 | 49.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 21 | 23.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 21 | 23.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, Day 0 | 34.50 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 10 | 64.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, Day 0 | 85.50 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 42 | 163.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 10 | 82.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 21 | 100.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 42 | 47.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, Day 0 | 7.50 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 10 | 1.50 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 21 | 24.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 10 | 51.50 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 42 | 110.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 21 | 48.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, Day 0 | 77.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, Day 0 | 25.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 10 | 71.50 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 21 | 38.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 42 | 29.50 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 21 | 1.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 10 | 1.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, DAY 42 | 49.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, Day 0 | 4.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 10 | 1.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 21 | 1.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-IL-2, DAY 42 | 25.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific CD8 T-cells | CD8-TNF-α, Day 0 | 10.50 CD8+ T-cells/million cells |
Secondary
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L).
Time frame: At Days 0, 10, 21 and 42 post vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 10 | 1028.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 42 | 342.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 42 | 1037.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 21 | 1069.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 10 | 1049.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, Day 0 | 557.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 21 | 1118.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 21 | 411.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 42 | 1100.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 10 | 466.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, Day 0 | 583.00 T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, Day 0 | 278.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, Day 0 | 785.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 42 | 332.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 21 | 1396.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 10 | 457.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 10 | 1148.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 21 | 1243.50 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, Day 0 | 233.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 42 | 1088.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 10 | 1148.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 42 | 1349.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 21 | 482.00 T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, Day 0 | 574.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 42 | 346.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, Day 0 | 750.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 21 | 1212.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 10 | 582.50 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 42 | 967.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 21 | 516.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 10 | 981.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 42 | 945.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, Day 0 | 198.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 21 | 1074.00 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 10 | 1066.50 T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, Day 0 | 782.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 21 | 228.50 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, Day 0 | 472.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 10 | 844.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 21 | 791.50 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 42 | 965.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, Day 0 | 438.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 10 | 769.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 21 | 788.50 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 42 | 999.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, Day 0 | 160.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 10 | 365.00 T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 42 | 344.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, Day 0 | 299.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, Day 0 | 738.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 21 | 1555.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 42 | 1600.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 10 | 463.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 42 | 1492.50 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 21 | 1536.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 21 | 484.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, Day 0 | 720.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 10 | 1275.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 10 | 1161.00 T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 42 | 669.50 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 21 | 974.50 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, Day 0 | 714.00 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 42 | 1177.50 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 42 | 1198.00 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, Day 0 | 212.50 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 21 | 989.50 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 42 | 445.00 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 10 | 400.00 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 10 | 1194.00 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 21 | 391.00 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, Day 0 | 691.00 T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 10 | 1158.00 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 21 | 900.50 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 42 | 1059.50 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 42 | 984.00 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 42 | 483.00 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 21 | 412.00 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, Day 0 | 594.50 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, Day 0 | 600.00 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 21 | 972.50 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-CD40L, DAY 10 | 886.00 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, DAY 10 | 245.00 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-IFN-γ, Day 0 | 217.50 T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | CD4-ALL DOUBLES, DAY 10 | 874.00 T-cells/million cells |
Secondary
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L).
Time frame: At Days 0, 10, 21 and 42 post-vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 21 | 1.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 10 | 104.50 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 42 | 1.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, Day 0 | 1.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 10 | 68.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 10 | 1.50 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 21 | 15.50 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 21 | 76.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, Day 0 | 1.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, Day 0 | 107.00 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 42 | 17.50 CD8+ T-cells/million cells |
| SB218352_15 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 42 | 25.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, Day 0 | 1.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 42 | 70.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 21 | 19.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 10 | 1.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 42 | 1.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 21 | 1.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 42 | 1.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 10 | 1.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 21 | 1.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, Day 0 | 62.00 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, Day 0 | 21.50 CD8+ T-cells/million cells |
| SB218352_8 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 10 | 47.50 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 21 | 51.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, Day 0 | 104.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 42 | 60.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 42 | 167.50 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 10 | 3.50 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, Day 0 | 97.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 10 | 148.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 10 | 1.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, Day 0 | 49.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 42 | 48.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 21 | 54.00 CD8+ T-cells/million cells |
| SB218352_4 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 21 | 57.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 21 | 29.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 10 | 1.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 21 | 1.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 42 | 25.50 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, Day 0 | 83.50 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 10 | 102.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 21 | 51.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 42 | 147.50 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, Day 0 | 1.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, Day 0 | 1.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 10 | 50.00 CD8+ T-cells/million cells |
| SB218352_2 Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 42 | 82.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, Day 0 | 52.50 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 21 | 172.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, Day 0 | 1.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 42 | 1.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 42 | 163.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 10 | 1.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 21 | 1.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 10 | 49.50 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 21 | 50.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 10 | 34.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, Day 0 | 83.00 CD8+ T-cells/million cells |
| SB218352_8AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 42 | 98.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 10 | 73.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, Day 0 | 1.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 42 | 173.50 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 42 | 26.50 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, Day 0 | 83.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, Day 0 | 50.50 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 10 | 49.50 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 42 | 94.50 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 10 | 48.50 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 21 | 1.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 21 | 49.00 CD8+ T-cells/million cells |
| SB218352_4AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 21 | 98.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 21 | 1.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, Day 0 | 1.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, Day 0 | 12.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 10 | 17.50 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 21 | 1.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 42 | 3.50 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, Day 0 | 1.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 42 | 50.50 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-ALL DOUBLES, DAY 42 | 100.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-IFN-γ, DAY 10 | 49.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 10 | 1.00 CD8+ T-cells/million cells |
| SB218352_2AL Group: | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | CD8-CD40L, DAY 21 | 1.00 CD8+ T-cells/million cells |
Secondary
Number of Subjects With Antibody Persistence
Antibody persistence was evaluated in terms of seroprotection rate (SPR) against influenza A subtype H9N2 and seroconversion rate (SCR) against influenza A subtype H9N2.
Time frame: At Days 189 and 365
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB218352_15 Group: | Number of Subjects With Antibody Persistence | SPR, Day 365 | 13 Participants |
| SB218352_15 Group: | Number of Subjects With Antibody Persistence | SCR, Day 189 | 8 Participants |
| SB218352_15 Group: | Number of Subjects With Antibody Persistence | SCR, Day 365 | 8 Participants |
| SB218352_15 Group: | Number of Subjects With Antibody Persistence | SPR, Day 189 | 13 Participants |
| SB218352_8 Group: | Number of Subjects With Antibody Persistence | SCR, Day 189 | 9 Participants |
| SB218352_8 Group: | Number of Subjects With Antibody Persistence | SPR, Day 189 | 9 Participants |
| SB218352_8 Group: | Number of Subjects With Antibody Persistence | SPR, Day 365 | 14 Participants |
| SB218352_8 Group: | Number of Subjects With Antibody Persistence | SCR, Day 365 | 13 Participants |
| SB218352_4 Group: | Number of Subjects With Antibody Persistence | SPR, Day 189 | 11 Participants |
| SB218352_4 Group: | Number of Subjects With Antibody Persistence | SPR, Day 365 | 10 Participants |
| SB218352_4 Group: | Number of Subjects With Antibody Persistence | SCR, Day 365 | 8 Participants |
| SB218352_4 Group: | Number of Subjects With Antibody Persistence | SCR, Day 189 | 9 Participants |
| SB218352_2 Group: | Number of Subjects With Antibody Persistence | SPR, Day 189 | 6 Participants |
| SB218352_2 Group: | Number of Subjects With Antibody Persistence | SCR, Day 189 | 4 Participants |
| SB218352_2 Group: | Number of Subjects With Antibody Persistence | SPR, Day 365 | 7 Participants |
| SB218352_2 Group: | Number of Subjects With Antibody Persistence | SCR, Day 365 | 5 Participants |
| SB218352_8AL Group: | Number of Subjects With Antibody Persistence | SPR, Day 189 | 8 Participants |
| SB218352_8AL Group: | Number of Subjects With Antibody Persistence | SCR, Day 189 | 6 Participants |
| SB218352_8AL Group: | Number of Subjects With Antibody Persistence | SPR, Day 365 | 11 Participants |
| SB218352_8AL Group: | Number of Subjects With Antibody Persistence | SCR, Day 365 | 10 Participants |
| SB218352_4AL Group: | Number of Subjects With Antibody Persistence | SPR, Day 189 | 10 Participants |
| SB218352_4AL Group: | Number of Subjects With Antibody Persistence | SCR, Day 365 | 5 Participants |
| SB218352_4AL Group: | Number of Subjects With Antibody Persistence | SPR, Day 365 | 6 Participants |
| SB218352_4AL Group: | Number of Subjects With Antibody Persistence | SCR, Day 189 | 7 Participants |
| SB218352_2AL Group: | Number of Subjects With Antibody Persistence | SCR, Day 365 | 2 Participants |
| SB218352_2AL Group: | Number of Subjects With Antibody Persistence | SPR, Day 365 | 4 Participants |
| SB218352_2AL Group: | Number of Subjects With Antibody Persistence | SCR, Day 189 | 3 Participants |
| SB218352_2AL Group: | Number of Subjects With Antibody Persistence | SPR, Day 189 | 3 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Antibody Persistence | SPR, Day 189 | 12 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Antibody Persistence | SCR, Day 365 | 19 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Antibody Persistence | SPR, Day 365 | 20 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Antibody Persistence | SCR, Day 189 | 10 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Antibody Persistence | SPR, Day 365 | 13 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Antibody Persistence | SPR, Day 189 | 7 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Antibody Persistence | SCR, Day 189 | 6 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Antibody Persistence | SCR, Day 365 | 10 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Antibody Persistence | SPR, Day 365 | 13 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Antibody Persistence | SCR, Day 189 | 5 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Antibody Persistence | SCR, Day 365 | 12 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Antibody Persistence | SPR, Day 189 | 5 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Antibody Persistence | SCR, Day 189 | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Antibody Persistence | SCR, Day 365 | 4 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Antibody Persistence | SPR, Day 365 | 6 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Antibody Persistence | SPR, Day 189 | 2 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Antibody Persistence | SPR, Day 365 | 20 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Antibody Persistence | SCR, Day 365 | 17 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Antibody Persistence | SPR, Day 189 | 14 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Antibody Persistence | SCR, Day 189 | 9 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Antibody Persistence | SPR, Day 189 | 7 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Antibody Persistence | SPR, Day 365 | 17 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Antibody Persistence | SCR, Day 189 | 5 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Antibody Persistence | SCR, Day 365 | 15 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Antibody Persistence | SCR, Day 365 | 14 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Antibody Persistence | SPR, Day 365 | 16 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Antibody Persistence | SPR, Day 189 | 5 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Antibody Persistence | SCR, Day 189 | 2 Participants |
Secondary
Number of Subjects With Any SAEs
A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). Only Subset 2 groups had available data for the specified time frame.
Time frame: Up to 30-day post Dose 3 (Days 365-394)
Population: The analysis was performed on the Total Vaccinated Cohort (TVc) of Subset 2, which included all vaccinated subjects (for whom the diary card was available).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB218352_15 Group: | Number of Subjects With Any SAEs | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Any SAEs | 2 Participants |
| SB218352_4 Group: | Number of Subjects With Any SAEs | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Any SAEs | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Any SAEs | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Any SAEs | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Any SAEs | 0 Participants |
Secondary
Number of Subjects With SAEs
A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization).
Time frame: Within the 365-day post-vaccination period (Days 0-364 for Subset 1 groups) and within the 395-day post-vaccination period (Days 0-394 for Subset 2 groups)
Population: The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB218352_15 Group: | Number of Subjects With SAEs | Related SAEs | 0 Participants |
| SB218352_15 Group: | Number of Subjects With SAEs | Any SAEs | 1 Participants |
| SB218352_15 Group: | Number of Subjects With SAEs | Grade 3 SAEs | 1 Participants |
| SB218352_8 Group: | Number of Subjects With SAEs | Any SAEs | 0 Participants |
| SB218352_8 Group: | Number of Subjects With SAEs | Grade 3 SAEs | 0 Participants |
| SB218352_8 Group: | Number of Subjects With SAEs | Related SAEs | 0 Participants |
| SB218352_4 Group: | Number of Subjects With SAEs | Any SAEs | 0 Participants |
| SB218352_4 Group: | Number of Subjects With SAEs | Grade 3 SAEs | 0 Participants |
| SB218352_4 Group: | Number of Subjects With SAEs | Related SAEs | 0 Participants |
| SB218352_2 Group: | Number of Subjects With SAEs | Grade 3 SAEs | 0 Participants |
| SB218352_2 Group: | Number of Subjects With SAEs | Any SAEs | 0 Participants |
| SB218352_2 Group: | Number of Subjects With SAEs | Related SAEs | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With SAEs | Related SAEs | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With SAEs | Any SAEs | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With SAEs | Grade 3 SAEs | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With SAEs | Grade 3 SAEs | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With SAEs | Related SAEs | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With SAEs | Any SAEs | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With SAEs | Related SAEs | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With SAEs | Grade 3 SAEs | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With SAEs | Any SAEs | 1 Participants |
| SB218352_15 Subset 2 | Number of Subjects With SAEs | Any SAEs | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With SAEs | Any SAEs | 2 Participants |
| SB218352_4 Subset 2 | Number of Subjects With SAEs | Any SAEs | 1 Participants |
| SB218352_2 Subset 2 | Number of Subjects With SAEs | Any SAEs | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With SAEs | Any SAEs | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With SAEs | Any SAEs | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With SAEs | Any SAEs | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization).
Time frame: From Day 0 to Day 51
Population: The analysis was performed on the Total Vaccinated Cohort (TVc), which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB218352_15 Group: | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| SB218352_2 Group: | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.
Time frame: During the 4-days (Day 0-3) post Dose 1
Population: The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 2 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 4 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 3 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 3 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 4 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 3 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 2 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 2 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 2 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 2 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 2 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 3 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 5 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 6 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 3 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 4 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 4 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 4 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 2 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 3 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 2 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 3 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 2 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 3 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 2 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 4 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 3 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 8 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 3 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 4 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 4 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 3 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 2 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 6 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 3 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 2 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 5 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 2 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 6 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 1 Participants |
Secondary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.
Time frame: During the 4-days post Dose 2 (Days 21-24)
Population: The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 2 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 3 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 4 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 3 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 2 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 3 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 3 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 2 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 2 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 2 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 6 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 2 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 1 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 2 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 4 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 3 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 3 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 4 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 3 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 5 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 2 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 4 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 2 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 2 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 2 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 2 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 3 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
Secondary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.
Time frame: During the 4-Days (Day 0-3) across doses 1 and 2
Population: The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 5 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 2 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 3 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 2 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 2 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 3 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 2 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 5 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 7 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 6 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 2 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 4 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 2 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 2 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 4 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 2 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 3 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 3 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 3 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 2 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 5 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 4 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 11 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 5 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 5 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 2 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 5 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 4 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 5 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 3 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 2 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 6 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 1 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 2 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 5 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 4 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 11 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 3 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 3 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 4 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 2 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 4 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 2 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 6 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 4 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 7 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 5 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 3 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 6 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 4 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 2 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 7 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Temperature (Axillary) (°C) | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature (Axillary) (°C) | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 3 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 5 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Temperature (Axillary) (°C) | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 3 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
Secondary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axilar temperature higher than (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = fever higher than (\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.
Time frame: During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)
Population: The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 3 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 2 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 2 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 2 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 4 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 2 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 1 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 2 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 2 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 1 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 3 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 2 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 3 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 2 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 3 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 3 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Myalgia | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Sweating | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Myalgia | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Headache | 2 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Any Fatigue | 2 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 1 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Headache | 3 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 2 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Sweating | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Myalgia | 2 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Shivering | 1 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Fatigue | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Headache | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Fatigue | 1 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Myalgia | 2 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Myalgia | 1 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 1 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Sweating | 1 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Headache | 1 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Headache | 1 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Headache | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Myalgia | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Myalgia | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Fatigue | 2 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 1 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Sweating | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Headache | 1 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Headache | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Myalgia | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Fatigue | 1 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Myalgia | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Any Sweating | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Shivering | 1 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Myalgia | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Sweating | 2 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Headache | 1 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Myalgia | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Fatigue | 1 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Sweating | 1 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Fatigue | 1 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Shivering | 1 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Headache | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Fatigue | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Myalgia | 1 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Sweating | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Sweating | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Headache | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Shivering | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Myalgia | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Sweating | 1 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Myalgia | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Shivering | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Myalgia | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Shivering | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Arthralgia | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Fatigue | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Fatigue | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Related Headache | 1 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Sweating | 1 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Arthralgia | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited General Symptoms | Any Headache | 2 Participants |
Secondary
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm).
Time frame: During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)
Population: The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm) | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain | 6 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm) | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm) | 5 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm) | 4 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm) | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm) | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm) | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm) | 3 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain | 5 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm) | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm) | 2 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm) | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm) | 2 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm) | 4 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm) | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain | 3 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm) | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm) | 3 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm) | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm) | 4 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Any Pain | 9 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm) | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm) | 4 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm) | 5 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm) | 7 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm) | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm) | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Any Pain | 8 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm) | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm) | 4 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Any Pain | 6 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm) | 3 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm) | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Redness (mm) | 3 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm) | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm) | 3 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Pain | 4 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm) | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm) | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm) | 1 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm) | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Redness (mm) | 1 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Pain | 1 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm) | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Pain | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Redness (mm) | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm) | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm) | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm) | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm) | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm) | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Pain | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Redness (mm) | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm) | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Redness (mm) | 1 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Pain | 1 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm) | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm) | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm) | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Redness (mm) | 1 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm) | 2 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Pain | 1 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm) | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm) | 2 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm) | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Redness (mm) | 3 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Any Pain | 2 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm) | 0 Participants |
Secondary
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm).
Time frame: During the 4-days post Dose 1 (Days 0-3), post Dose 2 (Days 21-24) and across these doses
Population: The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Across doses | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 8 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Dose 1 | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Dose 1 | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Dose 2 | 2 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Dose 1 | 4 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Across doses | 5 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Dose 2 | 3 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Across doses | 8 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Across doses | 12 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Dose 1 | 7 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Dose 2 | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Dose 2 | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Across doses | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 7 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Dose 2 | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Dose 2 | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Across doses | 7 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 3 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Across doses | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Dose 1 | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Across doses | 2 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Dose 1 | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Dose 1 | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Across doses | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 4 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Across doses | 5 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Dose 2 | 3 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Dose 2 | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Dose 1 | 4 Participants |
| SB218352_8 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Across doses | 9 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Dose 1 | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Dose 1 | 3 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Dose 2 | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 4 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Across doses | 5 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Dose 2 | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Dose 2 | 3 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Dose 2 | 3 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Across doses | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 6 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Dose 1 | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Dose 1 | 4 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Across doses | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Across doses | 6 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Dose 2 | 2 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Dose 2 | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Dose 1 | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Across doses | 2 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Across doses | 4 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Dose 1 | 1 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Dose 1 | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Dose 1 | 1 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 2 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Across doses | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Across doses | 2 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Dose 2 | 2 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Dose 2 | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 2 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Across doses | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Dose 1 | 10 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 8 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Dose 1 | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Dose 1 | 8 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Dose 1 | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 5 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Dose 2 | 4 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Dose 2 | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Dose 2 | 3 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Dose 2 | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Across doses | 10 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Across doses | 11 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Across doses | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Across doses | 10 Participants |
| SB218352_8AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Across doses | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Across doses | 9 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Dose 2 | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Dose 2 | 3 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 4 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 8 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Across doses | 8 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Dose 1 | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Dose 1 | 4 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Across doses | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Dose 1 | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Dose 1 | 6 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Across doses | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Across doses | 5 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Dose 2 | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Dose 2 | 4 Participants |
| SB218352_4AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Dose 2 | 2 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Dose 2 | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Across doses | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Dose 2 | 4 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Across doses | 7 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 8 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Across doses | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness (mm), Dose 1 | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 6 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Dose 1 | 5 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Dose 2 | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Any Redness (mm), Across doses | 7 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling (mm), Dose 1 | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Any Pain, Across doses | 9 Participants |
| SB218352_2AL Group: | Number of Subjects With Solicited Local Symptoms | Any Swelling (mm), Dose 1 | 7 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.
Time frame: During the 30-days (Day 0-30) post vaccination
Population: The analysis was performed on the Total Vaccinated Cohort (TVc), which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB218352_15 Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 1 Participants |
| SB218352_15 Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 8 Participants |
| SB218352_15 Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 2 Participants |
| SB218352_8 Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 1 Participants |
| SB218352_8 Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 3 Participants |
| SB218352_4 Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 3 Participants |
| SB218352_4 Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 1 Participants |
| SB218352_2 Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 6 Participants |
| SB218352_2 Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 4 Participants |
| SB218352_8AL Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 4 Participants |
| SB218352_4AL Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 2 Participants |
| SB218352_2AL Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 1 Participants |
| SB218352_2AL Group: | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 7 Participants |
Secondary
Number of Subjects With Unsolicited 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.
Time frame: During the 30-days post Dose 3 (Days 189-219 for Subset 1 groups and Days 365-395 for Subset 2 groups)
Population: The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB218352_15 Group: | Number of Subjects With Unsolicited AEs | Any unsolicited AEs | 2 Participants |
| SB218352_15 Group: | Number of Subjects With Unsolicited AEs | Related unsolicited AEs | 0 Participants |
| SB218352_15 Group: | Number of Subjects With Unsolicited AEs | Grade 3 unsolicited AEs | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Unsolicited AEs | Any unsolicited AEs | 2 Participants |
| SB218352_8 Group: | Number of Subjects With Unsolicited AEs | Grade 3 unsolicited AEs | 0 Participants |
| SB218352_8 Group: | Number of Subjects With Unsolicited AEs | Related unsolicited AEs | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Unsolicited AEs | Related unsolicited AEs | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Unsolicited AEs | Grade 3 unsolicited AEs | 0 Participants |
| SB218352_4 Group: | Number of Subjects With Unsolicited AEs | Any unsolicited AEs | 3 Participants |
| SB218352_2 Group: | Number of Subjects With Unsolicited AEs | Any unsolicited AEs | 4 Participants |
| SB218352_2 Group: | Number of Subjects With Unsolicited AEs | Grade 3 unsolicited AEs | 0 Participants |
| SB218352_2 Group: | Number of Subjects With Unsolicited AEs | Related unsolicited AEs | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Unsolicited AEs | Grade 3 unsolicited AEs | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Unsolicited AEs | Related unsolicited AEs | 0 Participants |
| SB218352_8AL Group: | Number of Subjects With Unsolicited AEs | Any unsolicited AEs | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Unsolicited AEs | Any unsolicited AEs | 1 Participants |
| SB218352_4AL Group: | Number of Subjects With Unsolicited AEs | Related unsolicited AEs | 0 Participants |
| SB218352_4AL Group: | Number of Subjects With Unsolicited AEs | Grade 3 unsolicited AEs | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Unsolicited AEs | Grade 3 unsolicited AEs | 0 Participants |
| SB218352_2AL Group: | Number of Subjects With Unsolicited AEs | Any unsolicited AEs | 5 Participants |
| SB218352_2AL Group: | Number of Subjects With Unsolicited AEs | Related unsolicited AEs | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Unsolicited AEs | Any unsolicited AEs | 1 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Unsolicited AEs | Related unsolicited AEs | 0 Participants |
| SB218352_15 Subset 2 | Number of Subjects With Unsolicited AEs | Grade 3 unsolicited AEs | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Unsolicited AEs | Any unsolicited AEs | 2 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Unsolicited AEs | Related unsolicited AEs | 0 Participants |
| SB218352_8 Subset 2 | Number of Subjects With Unsolicited AEs | Grade 3 unsolicited AEs | 2 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Unsolicited AEs | Related unsolicited AEs | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Unsolicited AEs | Any unsolicited AEs | 0 Participants |
| SB218352_4 Subset 2 | Number of Subjects With Unsolicited AEs | Grade 3 unsolicited AEs | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Unsolicited AEs | Grade 3 unsolicited AEs | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Unsolicited AEs | Any unsolicited AEs | 0 Participants |
| SB218352_2 Subset 2 | Number of Subjects With Unsolicited AEs | Related unsolicited AEs | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Unsolicited AEs | Grade 3 unsolicited AEs | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Unsolicited AEs | Related unsolicited AEs | 0 Participants |
| SB218352_8AL Subset 2 | Number of Subjects With Unsolicited AEs | Any unsolicited AEs | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Unsolicited AEs | Grade 3 unsolicited AEs | 0 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Unsolicited AEs | Any unsolicited AEs | 1 Participants |
| SB218352_4AL Subset 2 | Number of Subjects With Unsolicited AEs | Related unsolicited AEs | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Unsolicited AEs | Grade 3 unsolicited AEs | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Unsolicited AEs | Related unsolicited AEs | 0 Participants |
| SB218352_2AL Subset 2 | Number of Subjects With Unsolicited AEs | Any unsolicited AEs | 2 Participants |
Secondary
Seroconversion Factor (SCF) for Influenza A Subtype H9N2.
SCF was defined as the fold increase in serum HI GMTs at the post-vaccination time points compared to Day 0, for each vaccine strain.
Time frame: At Days 189 and 365
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SB218352_15 Group: | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 365 | 3.1 fold increase |
| SB218352_15 Group: | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 189 | 2.9 fold increase |
| SB218352_8 Group: | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 189 | 3.4 fold increase |
| SB218352_8 Group: | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 365 | 5.4 fold increase |
| SB218352_4 Group: | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 365 | 4.3 fold increase |
| SB218352_4 Group: | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 189 | 3.7 fold increase |
| SB218352_2 Group: | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 365 | 2.1 fold increase |
| SB218352_2 Group: | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 189 | 2.3 fold increase |
| SB218352_8AL Group: | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 189 | 3.2 fold increase |
| SB218352_8AL Group: | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 365 | 4.3 fold increase |
| SB218352_4AL Group: | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 189 | 3.2 fold increase |
| SB218352_4AL Group: | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 365 | 2.9 fold increase |
| SB218352_2AL Group: | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 365 | 2.1 fold increase |
| SB218352_2AL Group: | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 189 | 1.8 fold increase |
| SB218352_15 Subset 2 | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 365 | 11.9 fold increase |
| SB218352_15 Subset 2 | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 189 | 3.3 fold increase |
| SB218352_8 Subset 2 | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 365 | 5.5 fold increase |
| SB218352_8 Subset 2 | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 189 | 2.7 fold increase |
| SB218352_4 Subset 2 | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 365 | 5.6 fold increase |
| SB218352_4 Subset 2 | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 189 | 2.1 fold increase |
| SB218352_2 Subset 2 | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 189 | 1.5 fold increase |
| SB218352_2 Subset 2 | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 365 | 2.8 fold increase |
| SB218352_8AL Subset 2 | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 365 | 11.2 fold increase |
| SB218352_8AL Subset 2 | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 189 | 5.8 fold increase |
| SB218352_4AL Subset 2 | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 365 | 7.5 fold increase |
| SB218352_4AL Subset 2 | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 189 | 2.2 fold increase |
| SB218352_2AL Subset 2 | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 189 | 1.7 fold increase |
| SB218352_2AL Subset 2 | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF, Day 365 | 5.4 fold increase |