Respiratory Syncytial Virus Infections
Conditions
Keywords
Vaccines, Safety, Immunogenicity, Reactogenicity, Respiratory Syncytial Viruses
Brief summary
The purpose of this study is to evaluate different dose levels of the investigational RSV maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data. As this is the first time the investigational RSV maternal vaccine (GSK3888550A) is being been used in humans, this study will be performed in healthy non-pregnant women 18-45 years of age before testing in pregnant women.
Detailed description
Healthy non-pregnant women 18-45 years of age will be randomized in a 1:1:1:1 ratio to receive one of three dose levels (30, 60, 120 micrograms \[µg\]) of the investigational RSV maternal vaccine (GSK3888550A) or placebo, administered as a single intramuscular injection (IM). There will be a screening visit and five study visits scheduled at Day 1 (study vaccination), Day 8, Day 31, Day 61, and Day 91 to evaluate the primary and secondary objectives of safety/reactogenicity and immunogenicity profiles of the 3 dose levels. Subjects will also be contacted at Day 181. During this contact, the investigator (or delegate) will ask the subject if she has experienced any serious adverse events (SAEs) and or any adverse events (AEs) leading to study withdrawal since the last study visit (Day 360), as well as if she has become pregnant during the post-vaccination period. The investigator (or delegate) will also ask the subject about concomitant vaccinations/products/medications that she has received since the last study visit (D91). Contact should be performed preferably via telephone. Other means of contact (email/other) may be acceptable provided the required information can be fully collected.
Interventions
BIOLOGICALGSK3888550A RSV Maternal vaccine formulation 1
Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm
BIOLOGICALGSK3888550A RSV Maternal vaccine formulation 2
Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm
BIOLOGICALGSK3888550A RSV Maternal vaccine formulation 3
Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm
DRUGPlacebo (Normal Saline)
Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Observer-blind In this study, the subject and study site personnel involved in the clinical evaluations of the subjects are blinded while other study personnel may be aware of the treatment assignments.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes will comply with the requirements of the protocol (e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study); * Written informed consent obtained from the subject; * Healthy female subjects; as established by medical history and clinical examination, aged 18 to 45 years at the time of the vaccination; * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception until 90 days after vaccination
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding vaccination or any planned use during the study period; * Concurrently participating in the active phase of another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product * Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune-modifying drugs, as well as administration of long acting immune modifying drugs, within 6 months prior to the vaccine dose (for corticosteroids, this will mean prednisone higher than or equal to (≥) 5 milligrams per day (mg/day), or equivalent). Inhaled and topical steroids are allowed; * Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study vaccination, or planned administration until 90 days post-vaccination; * Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after study vaccination; * Previous experimental vaccination against RSV; * Presence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports; * Family history of congenital or hereditary immunodeficiency; * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination; * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine; * Any acute or chronic, clinically significant disease, as determined by physical examination, laboratory screening tests, subject personal report and/or health care provider information. The following conditions will be exclusionary: * Diabetes mellitus, * Respiratory diseases, such as: * Chronic Pulmonary diseases, including Chronic Obstructive Pulmonary Disease (COPD), * Bronchopulmonary dysplasia (note: history of past bronchopulmonary dysplasia as a neonate/infant will not be exclusionary), * Uncontrolled asthma or asthma necessitating treatment with chronic systemic glucocorticoids * Significant and/or uncontrolled psychiatric illness: * hospitalization for psychiatric illness, history of suicide attempt(s) or confinement for danger to self or others within 10 years * clinically significant depression * Major neurological disease including: * seizure or adulthood epilepsy (note: history of febrile convulsion in childhood is not exclusionary) * myasthenia gravis * history of repetitive migraine mal/status migrainosus * Significant cardiovascular disease, including: * Uncontrolled arterial hypertension, * Congenital heart disease (with the exception of corrected atrial or ventricular septal defects), * Previous myocardial infarction, * Valvular heart disease or history of rheumatic fever, * Previous bacterial endocarditis, * History of cardiac surgery (with the exception of corrected atrial or ventricular septal defects), * Personal or family history of cardiomyopathy or sudden adult death. * Known or suspected Hepatitis B or Hepatitis C infection, * Any other significant uncontrolled medical illness, defined as any illness requiring new medical and/or surgical treatment or significant modification of treatment dose due to uncontrolled symptoms or drug toxicity, within 3 months prior to study vaccination. * History of or current autoimmune disease; * Body mass index (BMI) \> 40 Kilograms (kg)/square meters(m\^2); * Pregnant or lactating female; * Female planning to become pregnant or planning to discontinue contraceptive precautions; * Hypersensitivity to latex; * Lymphoproliferative disorder or malignancy within previous 5 years; * Acute disease and/or fever at the time of enrolment; * Fever is defined as temperature ≥ 38°C/100.4°F * For subjects with acute disease and/or fever at the time of enrolment, Visit 1 will be rescheduled within the allowed window for the visit. * Subjects with fever at screening may be re-screened 1 time at a later date. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. * Any clinically significant or any ≥ Grade 2\* haematological (haemoglobin level, white blood cell, lymphocyte, neutrophil, eosinophil, and platelets) and biochemical (alanine aminotransferase \[ALT\] aspartate aminotransferase \[AST\], creatinine, blood urea nitrogen \[BUN\]) laboratory abnormality detected at the last screening blood sampling; \*Grading of laboratory parameters will be based on the FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. For Grade 1 laboratory abnormalities, the investigator should use clinical judgement to decide which ones are clinically relevant. Subjects with haematological/biochemical values out of normal range at screening which are expected to be temporary, may be re-screened 1 time at a later date. * Any other condition that the investigator judges may interfere with study procedures or findings; * Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe; * Alcoholism, drug abuse and/or use disorder within the past two years (as defined in Diagnostic and Statistical Manual of Mental Disorders \[DSM-5\] Diagnostic Criteria); * Planned move to a location that will prohibit participating in the trial until study end.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | At Day 31 | Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration \[FDA\] Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline \[e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 31\]. Any corresponding to any grade and Grade 0 to normal ranges. |
| Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | At Day 8 | Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration \[FDA\] Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline \[e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 8\]. Any corresponding to any grade and Grade 0 to normal ranges. |
| Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | At Day 31 | Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration \[FDA\] Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline \[e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 31\]. Any corresponding to any grade and Grade 0 to normal ranges. |
| Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | At Day 8 | Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration \[FDA\] Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline \[e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 8\]. Any corresponding to any grade and Grade 0 to normal ranges. |
| Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days) | Assessed solicited local symptoms include pain, redness and swelling, at the injection site. Any = occurrence of the AE regardless of intensity grade. Any Redness and swelling symptom = symptom reported with a surface diameter greater than 20 millimeters. Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 3 redness/swelling = symptom reported with a surface diameter greater than 100 millimeters. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days) | Assessed solicited general symptoms include fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and fever. Any Fatigue, gastrointestinal symptoms and headache = occurrence of the symptom regardless of intensity grade and relationship. Any Fever = temperature higher than or equal to 38.0 degrees Celsius (°C), or 100.4 degrees Fahrenheit (°F). Grade 3 Fatigue, gastrointestinal symptoms and headache = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than 39.0 degrees Celsius (°C), or 102.2 degrees Fahrenheit (°F). Related fatigue, gastrointestinal symptoms, headache and fever(\>38°C) = symptoms assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any Unsolicited AEs During a 30-day Follow-up Period | During a 30-day follow-up period after vaccination (i.e., on the day of vaccination and 29 subsequent days) | 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 is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) During a 30-day Follow-up Period | From Day 1 (vaccination) up to Day 30 (i.e., on the day of vaccination and 29 subsequent days) | Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | At Day 8 | Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR). \[e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 8\]. |
| Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | At Day 31 | Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) \[e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 31\]. |
| Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | At Day 8 | Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine. Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR)\[e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 8\]. |
| Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | At Day 31 | Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine and blood urea nitrogen (BUN). Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) \[e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 31\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing Antibody (Nab) Titers Against RSV Serotype A | At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91) | Anti RSV-A neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60), calculated on subjects with anti-RSV-A neutralizing antibody titer equal to or above the assay cut-off 18 ED60. |
| Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91) | Concentrations are presented as geometric mean concentrations (GMCs), expressed in Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL), calculated on subjects with anti-RSVPreF3 antibody concentration equal to or above the assay cut-off 25 EL.U/mL. |
| Number of Subjects With SAEs | From Day 1 (vaccination) up to Day 91 and up to Day 181 | Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. |
Countries
Finland, Germany, United States
Participant flow
Recruitment details
The study was conducted at 11 centers in 3 countries: 4 in Finland, 5 in Germany and 2 in the USA.
Pre-assignment details
Among 579 screened subjects in this study, 77 subjects were screen failure. 502 subjects were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| RSV MAT Formulation 1 Group Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm | 124 |
| RSV MAT Formulation 2 Group Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm | 126 |
| RSV MAT Formulation 3 Group Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm | 126 |
| Control Group Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm | 126 |
| Total | 502 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | RSV MAT Formulation 1 Group | RSV MAT Formulation 2 Group | RSV MAT Formulation 3 Group | Control Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 32.5 Years STANDARD_DEVIATION 7.4 | 32.1 Years STANDARD_DEVIATION 7.9 | 31.5 Years STANDARD_DEVIATION 7.6 | 32.2 Years STANDARD_DEVIATION 7.1 | 32.1 Years STANDARD_DEVIATION 7.5 |
| Race/Ethnicity, Customized ASIAN | 1 Participants | 1 Participants | 2 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 5 Participants | 5 Participants | 4 Participants | 7 Participants | 21 Participants |
| Race/Ethnicity, Customized OTHER | 3 Participants | 0 Participants | 3 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized WHITE | 115 Participants | 120 Participants | 117 Participants | 114 Participants | 466 Participants |
| Sex: Female, Male Female | 124 Participants | 126 Participants | 126 Participants | 126 Participants | 502 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 0 / 126 | 0 / 126 | 0 / 126 |
| other Total, other adverse events | 94 / 124 | 96 / 126 | 105 / 126 | 83 / 126 |
| serious Total, serious adverse events | 0 / 124 | 0 / 126 | 1 / 126 | 2 / 126 |
Outcome results
Primary
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period
Assessed solicited local symptoms include pain, redness and swelling, at the injection site. Any = occurrence of the AE regardless of intensity grade. Any Redness and swelling symptom = symptom reported with a surface diameter greater than 20 millimeters. Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 3 redness/swelling = symptom reported with a surface diameter greater than 100 millimeters.
Time frame: During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)
Population: The analysis was performed on the Exposed Set, which included all subjects with the study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Pain | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Any Pain | 59 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Any Swelling | 5 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Any Redness | 8 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Swelling | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Redness | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Any Swelling | 7 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Swelling | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Redness | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Pain | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Any Pain | 64 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Any Redness | 14 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Any Pain | 67 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Any Redness | 10 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Redness | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Pain | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Swelling | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Any Swelling | 6 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Swelling | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Any Pain | 20 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Pain | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Any Redness | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Redness | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Any Swelling | 0 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Assessed solicited general symptoms include fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and fever. Any Fatigue, gastrointestinal symptoms and headache = occurrence of the symptom regardless of intensity grade and relationship. Any Fever = temperature higher than or equal to 38.0 degrees Celsius (°C), or 100.4 degrees Fahrenheit (°F). Grade 3 Fatigue, gastrointestinal symptoms and headache = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than 39.0 degrees Celsius (°C), or 102.2 degrees Fahrenheit (°F). Related fatigue, gastrointestinal symptoms, headache and fever(\>38°C) = symptoms assessed by the investigator as related to the vaccination.
Time frame: During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)
Population: The analysis was performed on the Exposed Set, which included all subjects with the study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Fever | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Fever | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Headache | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Fatigue | 41 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Headache | 17 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Fatigue | 25 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Gastrointestinal symptoms | 30 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Fatigue | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Fever | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Gastrointestinal symptoms | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Gastrointestinal symptoms | 12 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Headache | 37 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Fatigue | 5 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Headache | 51 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Gastrointestinal symptoms | 29 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Headache | 25 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Fever | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Headache | 6 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Fatigue | 49 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Gastrointestinal symptoms | 16 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Gastrointestinal symptoms | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Fatigue | 34 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Fever | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Fever | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Headache | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Fatigue | 41 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Fatigue | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Fatigue | 25 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Gastrointestinal symptoms | 23 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Gastrointestinal symptoms | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Gastrointestinal symptoms | 13 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Headache | 60 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Headache | 34 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Fever | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Fever | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Fever | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Gastrointestinal symptoms | 17 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Gastrointestinal symptoms | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Fatigue | 38 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Fever | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Gastrointestinal symptoms | 27 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Fatigue | 27 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Fever | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Fever | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Headache | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Any Headache | 32 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Grade 3 Fatigue | 4 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Related Headache | 17 Participants |
Primary
Number of Subjects With Any Unsolicited AEs During a 30-day Follow-up Period
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During a 30-day follow-up period after vaccination (i.e., on the day of vaccination and 29 subsequent days)
Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Formulation 1 Group | Number of Subjects With Any Unsolicited AEs During a 30-day Follow-up Period | 45 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Any Unsolicited AEs During a 30-day Follow-up Period | 43 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Any Unsolicited AEs During a 30-day Follow-up Period | 48 Participants |
| Control Group | Number of Subjects With Any Unsolicited AEs During a 30-day Follow-up Period | 44 Participants |
Primary
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine and blood urea nitrogen (BUN). Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) \[e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 31\].
Time frame: At Day 31
Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, WITHIN(SCR), ABOVE | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, WITHIN(SCR), WITHIN | 118 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, WITHIN(SCR), WITHIN | 115 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, ABOVE(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, WITHIN(SCR), WITHIN | 113 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, ABOVE(SCR), WITHIN | 4 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, WITHIN(SCR), ABOVE | 4 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, WITHIN(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, ABOVE(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, WITHIN(SCR), WITHIN | 112 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, ABOVE(SCR), ABOVE | 4 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, BELOW(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, BELOW(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, WITHIN(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, WITHIN(SCR), WITHIN | 117 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, WITHIN(SCR), ABOVE | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, WITHIN(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, WITHIN(SCR), ABOVE | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, ABOVE(SCR), WITHIN | 5 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, BELOW(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, WITHIN(SCR), WITHIN | 116 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, WITHIN(SCR), WITHIN | 118 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, WITHIN(SCR), ABOVE | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, BELOW(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, WITHIN(SCR), WITHIN | 113 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, WITHIN(SCR), WITHIN | 117 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, WITHIN(SCR), WITHIN | 121 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, ABOVE(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, WITHIN(SCR), WITHIN | 120 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, WITHIN(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, ABOVE(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, BELOW(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, BELOW(SCR), WITHIN | 5 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, WITHIN(SCR), WITHIN | 115 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, ABOVE(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, BELOW(SCR), WITHIN | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, WITHIN(SCR), ABOVE | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, ABOVE(SCR), ABOVE | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, BELOW(SCR), BELOW | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, ABOVE(SCR), ABOVE | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, BELOW(SCR), BELOW | 3 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, ABOVE(SCR), ABOVE | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, ABOVE(SCR), WITHIN | 6 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, ABOVE(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, BELOW(SCR), WITHIN | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, WITHIN(SCR), ABOVE | 4 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, WITHIN(SCR), WITHIN | 114 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, BELOW(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, WITHIN(SCR), BELOW | 2 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, WITHIN(SCR), BELOW | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, BELOW(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, ABOVE(SCR), ABOVE | 4 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, WITHIN(SCR), WITHIN | 116 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, ABOVE(SCR), WITHIN | 6 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, WITHIN(SCR), ABOVE | 6 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, BELOW(SCR), BELOW | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Creatinine, WITHIN(SCR), ABOVE | 3 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, WITHIN(SCR), ABOVE | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, WITHIN(SCR), WITHIN | 110 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, ABOVE(SCR), WITHIN | 2 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, WITHIN(SCR), WITHIN | 120 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, WITHIN(SCR), BELOW | 2 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, WITHIN(SCR), BELOW | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, ABOVE(SCR), ABOVE | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | BUN, BELOW(SCR), WITHIN | 0 Participants |
Primary
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine. Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR)\[e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 8\].
Time frame: At Day 8
Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, WITHIN(SCR), WITHIN | 116 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, ABOVE(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, WITHIN(SCR), WITHIN | 117 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, WITHIN(SCR), ABOVE | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, WITHIN(SCR), WITHIN | 113 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, ABOVE(SCR), ABOVE | 5 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, ABOVE(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, ABOVE(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, WITHIN(SCR), WITHIN | 114 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, WITHIN(SCR), ABOVE | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, BELOW(SCR), BELOW | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, ABOVE(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, BELOW(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, WITHIN(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, WITHIN(SCR), WITHIN | 115 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, WITHIN(SCR), ABOVE | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, WITHIN(SCR), WITHIN | 109 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, WITHIN(SCR), ABOVE | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, WITHIN(SCR), WITHIN | 118 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, WITHIN(SCR), WITHIN | 115 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, WITHIN(SCR), ABOVE | 6 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, WITHIN(SCR), ABOVE | 7 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, BELOW(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, ABOVE(SCR), WITHIN | 6 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, WITHIN(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, WITHIN(SCR), WITHIN | 120 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, WITHIN(SCR), ABOVE | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, ABOVE(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, WITHIN(SCR), WITHIN | 116 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, WITHIN(SCR), ABOVE | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, ABOVE(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, BELOW(SCR), BELOW | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, BELOW(SCR), WITHIN | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, WITHIN(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, WITHIN(SCR), WITHIN | 113 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, ABOVE(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, BELOW(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, BELOW(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, WITHIN(SCR), WITHIN | 119 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, ABOVE(SCR), ABOVE | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, BELOW(SCR), BELOW | 4 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, BELOW(SCR), BELOW | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, ABOVE(SCR), ABOVE | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, ABOVE(SCR), ABOVE | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, BELOW(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, ABOVE(SCR), WITHIN | 6 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, WITHIN(SCR), ABOVE | 2 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, ABOVE(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, WITHIN(SCR), BELOW | 3 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, WITHIN(SCR), WITHIN | 116 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, WITHIN(SCR), BELOW | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, WITHIN(SCR), WITHIN | 111 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, WITHIN(SCR), WITHIN | 118 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | AST, BELOW(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, ABOVE(SCR), ABOVE | 7 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, BELOW(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Creatinine, WITHIN(SCR), ABOVE | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, ABOVE(SCR), WITHIN | 2 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, WITHIN(SCR), ABOVE | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, WITHIN(SCR), WITHIN | 121 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, ABOVE(SCR), WITHIN | 3 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, ABOVE(SCR), ABOVE | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, WITHIN(SCR), BELOW | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | BUN, BELOW(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | ALT, WITHIN(SCR), ABOVE | 4 Participants |
Primary
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration \[FDA\] Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline \[e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 31\]. Any corresponding to any grade and Grade 0 to normal ranges.
Time frame: At Day 31
Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Creatinine, Any(SCR), GRADE 0 | 123 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 1(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Any(SCR), GRADE 0 | 117 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Any(SCR), GRADE 0 | 123 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Any(SCR), GRADE 0 | 121 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 2(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Any(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 0 | 123 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Any(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Creatinine, Grade 0(SCR), GRADE 0 | 123 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 0(SCR), GRADE 0 | 118 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 0(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Any(SCR), GRADE 1 | 6 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 1(SCR), GRADE 0 | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 1(SCR), GRADE 0 | 4 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 0(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 0(SCR), GRADE 0 | 113 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 2(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 2(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 0 | 123 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 0(SCR), GRADE 0 | 117 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Creatinine, Grade 0(SCR), GRADE 0 | 124 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Any(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 0(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Any(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Any(SCR), GRADE 0 | 123 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Creatinine, Any(SCR), GRADE 0 | 124 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 1(SCR), GRADE 0 | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Any(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 2(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Any(SCR), GRADE 0 | 122 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Any(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 0(SCR), GRADE 0 | 121 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Any(SCR), GRADE 0 | 121 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 0(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 2(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Any(SCR), GRADE 0 | 125 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Any(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 0(SCR), GRADE 0 | 122 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 1(SCR), GRADE 0 | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Any(SCR), GRADE 0 | 125 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Any(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 0(SCR), GRADE 0 | 125 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 0(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 1(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Any(SCR), GRADE 0 | 126 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Any(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 0 | 125 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 2(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Creatinine, Any(SCR), GRADE 0 | 126 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Creatinine, Grade 0(SCR), GRADE 0 | 126 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Any(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 0(SCR), GRADE 2 | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 2(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 0(SCR), GRADE 1 | 3 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 1 | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 0(SCR), GRADE 0 | 118 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 1(SCR), GRADE 2 | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Any(SCR), GRADE 2 | 2 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Any(SCR), GRADE 1 | 3 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Any(SCR), GRADE 2 | 2 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 1(SCR), GRADE 0 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Any(SCR), GRADE 0 | 121 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 1(SCR), GRADE 1 | 2 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Any(SCR), GRADE 1 | 6 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 2(SCR), GRADE 0 | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 1(SCR), GRADE 0 | 6 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 0(SCR), GRADE 2 | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Any(SCR), GRADE 0 | 118 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Creatinine, Any(SCR), GRADE 0 | 126 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 0(SCR), GRADE 1 | 4 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | ALT - increase by factor, Grade 0(SCR), GRADE 0 | 112 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Any(SCR), GRADE 0 | 125 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 1(SCR), GRADE 2 | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Any(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Any(SCR), GRADE 1 | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 1(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | AST - increase by factor, Grade 1(SCR), GRADE 0 | 3 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Creatinine, Grade 0(SCR), GRADE 0 | 126 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 0 | 124 Participants |
Primary
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration \[FDA\] Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline \[e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 8\]. Any corresponding to any grade and Grade 0 to normal ranges.
Time frame: At Day 8
Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 1(SCR), GRADE 0 | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 1 | 5 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 0 | 115 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 0 | 118 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 1(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 1(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 2(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Any(SCR), GRADE 0 | 123 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Any(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Any(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 0(SCR), GRADE 0 | 120 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 0(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 0(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 1(SCR), GRADE 0 | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Any(SCR), GRADE 0 | 122 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Any(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 0 | 122 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 2(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Any(SCR), GRADE 0 | 122 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Any(SCR), GRADE 3 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Grade 0(SCR), GRADE 0 | 122 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Grade 0(SCR), GRADE 3 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 0 | 123 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 0(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Any(SCR), GRADE 0 | 124 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 0(SCR), GRADE 3 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Any(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 2(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Any(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Any(SCR), GRADE 0 | 123 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 0 | 115 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Grade 0(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Grade 0(SCR), GRADE 0 | 124 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Any(SCR), GRADE 0 | 120 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 1(SCR), GRADE 0 | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 3 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 2(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Any(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 3 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Any(SCR), GRADE 3 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 1(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 0(SCR), GRADE 0 | 119 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 0 | 119 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Grade 0(SCR), GRADE 0 | 126 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 1(SCR), GRADE 0 | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 1(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 2(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Any(SCR), GRADE 0 | 124 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Any(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 2(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Any(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 0(SCR), GRADE 0 | 124 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 0(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Any(SCR), GRADE 0 | 126 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 1(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Any(SCR), GRADE 0 | 124 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Any(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Any(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 0 | 123 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Grade 0(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 0 | 124 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 0 | 121 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 3 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 1(SCR), GRADE 3 | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 0(SCR), GRADE 0 | 119 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 2 | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 0 | 117 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 2(SCR), GRADE 0 | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Any(SCR), GRADE 3 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 1 | 2 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 1 | 7 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 1(SCR), GRADE 0 | 3 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Any(SCR), GRADE 1 | 3 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 1(SCR), GRADE 1 | 5 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Any(SCR), GRADE 0 | 122 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 3 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Any(SCR), GRADE 3 | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 1(SCR), GRADE 1 | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Any(SCR), GRADE 0 | 126 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Grade 0(SCR), GRADE 0 | 126 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Any(SCR), GRADE 0 | 125 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 1(SCR), GRADE 0 | 3 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 0(SCR), GRADE 3 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 2(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Any(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | AST - increase by factor, Grade 0(SCR), GRADE 1 | 2 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | ALT - increase by factor, Grade 0(SCR), GRADE 0 | 114 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Any(SCR), GRADE 2 | 1 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Any(SCR), GRADE 3 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Creatinine, Grade 0(SCR), GRADE 3 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 1(SCR), GRADE 0 | 0 Participants |
| Control Group | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Blood Urea Nitrogen, Grade 0(SCR), GRADE 0 | 124 Participants |
Primary
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) \[e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 31\].
Time frame: At Day 31
Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, BELOW(SCR), BELOW | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, WITHIN(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, WITHIN(SCR), WITHIN | 105 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, ABOVE(SCR), ABOVE | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, BELOW(SCR), WITHIN | 4 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, BELOW(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, BELOW(SCR), BELOW | 6 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, WITHIN(SCR), BELOW | 4 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, WITHIN(SCR), WITHIN | 119 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, WITHIN(SCR), WITHIN | 109 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, WITHIN(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, WITHIN(SCR), ABOVE | 5 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, WITHIN(SCR), WITHIN | 115 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, ABOVE(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, ABOVE(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, WITHIN(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, WITHIN(SCR), WITHIN | 116 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, WITHIN(SCR), BELOW | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, ABOVE(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, WITHIN(SCR), ABOVE | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, BELOW(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, WITHIN(SCR), WITHIN | 112 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, WITHIN(SCR), WITHIN | 115 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, BELOW(SCR), BELOW | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, WITHIN(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, WITHIN(SCR), WITHIN | 117 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, WITHIN(SCR), ABOVE | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, ABOVE(SCR), ABOVE | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, WITHIN(SCR), WITHIN | 107 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, BELOW(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, WITHIN(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, WITHIN(SCR), BELOW | 5 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, WITHIN(SCR), BELOW | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, ABOVE(SCR), ABOVE | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, WITHIN(SCR), WITHIN | 114 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, ABOVE(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, WITHIN(SCR), WITHIN | 112 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, BELOW(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, BELOW(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, ABOVE(SCR), ABOVE | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, WITHIN(SCR), WITHIN | 119 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, WITHIN(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, BELOW(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, WITHIN(SCR), ABOVE | 7 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, WITHIN(SCR), ABOVE | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, ABOVE(SCR), WITHIN | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, BELOW(SCR), BELOW | 6 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, WITHIN(SCR), WITHIN | 115 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, BELOW(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, WITHIN(SCR), WITHIN | 121 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, WITHIN(SCR), BELOW | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, WITHIN(SCR), WITHIN | 119 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, WITHIN(SCR), BELOW | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, WITHIN(SCR), WITHIN | 114 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, WITHIN(SCR), ABOVE | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, WITHIN(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, WITHIN(SCR), WITHIN | 111 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, WITHIN(SCR), ABOVE | 6 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, ABOVE(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, ABOVE(SCR), ABOVE | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, BELOW(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, WITHIN(SCR), BELOW | 9 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, WITHIN(SCR), WITHIN | 105 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, WITHIN(SCR), ABOVE | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, ABOVE(SCR), WITHIN | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, ABOVE(SCR), ABOVE | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, WITHIN(SCR), WITHIN | 113 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, ABOVE(SCR), ABOVE | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, ABOVE(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, BELOW(SCR), BELOW | 8 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, WITHIN(SCR), ABOVE | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, WITHIN(SCR), ABOVE | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, WITHIN(SCR), WITHIN | 119 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, WITHIN(SCR), ABOVE | 4 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, ABOVE(SCR), WITHIN | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, WITHIN(SCR), BELOW | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, BELOW(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, WITHIN(SCR), WITHIN | 110 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, ABOVE(SCR), ABOVE | 5 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Lymphocytes, BELOW(SCR), BELOW | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, ABOVE(SCR), ABOVE | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, WITHIN(SCR), BELOW | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, BELOW(SCR), BELOW | 4 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, ABOVE(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, WITHIN(SCR), WITHIN | 119 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, ABOVE(SCR), ABOVE | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, BELOW(SCR), WITHIN | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, WITHIN(SCR), BELOW | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, BELOW(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, ABOVE(SCR), WITHIN | 5 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, WITHIN(SCR), BELOW | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Hemoglobin, BELOW(SCR), BELOW | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, ABOVE(SCR), ABOVE | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, ABOVE(SCR), ABOVE | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, BELOW(SCR), WITHIN | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, BELOW(SCR), BELOW | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, ABOVE(SCR), WITHIN | 4 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, WITHIN(SCR), ABOVE | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, WITHIN(SCR), WITHIN | 110 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, BELOW(SCR), WITHIN | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, WITHIN(SCR), WITHIN | 116 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, WITHIN(SCR), BELOW | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, ABOVE(SCR), WITHIN | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Platelets, WITHIN(SCR), BELOW | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, BELOW(SCR), WITHIN | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Neutrophils, BELOW(SCR), BELOW | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Eosinophils, WITHIN(SCR), ABOVE | 1 Participants |
Primary
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR). \[e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 8\].
Time frame: At Day 8
Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, WITHIN(SCR), BELOW | 5 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, BELOW(SCR), BELOW | 5 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, WITHIN(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, WITHIN(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, WITHIN(SCR), ABOVE | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, WITHIN(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, WITHIN(SCR), WITHIN | 117 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, WITHIN(SCR), WITHIN | 119 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, BELOW(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, WITHIN(SCR), WITHIN | 116 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, ABOVE(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, BELOW(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, BELOW(SCR), WITHIN | 4 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, WITHIN(SCR), BELOW | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, WITHIN(SCR), WITHIN | 108 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, ABOVE(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, WITHIN(SCR), WITHIN | 111 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, WITHIN(SCR), WITHIN | 112 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, ABOVE(SCR), ABOVE | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, BELOW(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, WITHIN(SCR), BELOW | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, WITHIN(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, WITHIN(SCR), WITHIN | 112 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, WITHIN(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, ABOVE(SCR), ABOVE | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, WITHIN(SCR), ABOVE | 5 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, ABOVE(SCR), ABOVE | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, WITHIN(SCR), WITHIN | 109 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, WITHIN(SCR), BELOW | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, WITHIN(SCR), ABOVE | 5 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, ABOVE(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, ABOVE(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, WITHIN(SCR), WITHIN | 111 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, WITHIN(SCR), ABOVE | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, BELOW(SCR), BELOW | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, WITHIN(SCR), WITHIN | 116 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, WITHIN(SCR), WITHIN | 108 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, BELOW(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, WITHIN(SCR), ABOVE | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, ABOVE(SCR), ABOVE | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, WITHIN(SCR), WITHIN | 115 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, WITHIN(SCR), WITHIN | 108 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, ABOVE(SCR), ABOVE | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, BELOW(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, BELOW(SCR), WITHIN | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, WITHIN(SCR), BELOW | 5 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, ABOVE(SCR), WITHIN | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, WITHIN(SCR), ABOVE | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, ABOVE(SCR), ABOVE | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, BELOW(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, WITHIN(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, WITHIN(SCR), WITHIN | 115 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, WITHIN(SCR), ABOVE | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, BELOW(SCR), BELOW | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, BELOW(SCR), WITHIN | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, WITHIN(SCR), BELOW | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, WITHIN(SCR), WITHIN | 112 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, WITHIN(SCR), ABOVE | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, BELOW(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, BELOW(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, WITHIN(SCR), BELOW | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, WITHIN(SCR), WITHIN | 117 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, ABOVE(SCR), WITHIN | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, ABOVE(SCR), ABOVE | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, BELOW(SCR), BELOW | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, WITHIN(SCR), WITHIN | 120 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, WITHIN(SCR), ABOVE | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, ABOVE(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, ABOVE(SCR), ABOVE | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, BELOW(SCR), WITHIN | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, WITHIN(SCR), BELOW | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, WITHIN(SCR), WITHIN | 119 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, WITHIN(SCR), ABOVE | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, ABOVE(SCR), WITHIN | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, ABOVE(SCR), ABOVE | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, WITHIN(SCR), BELOW | 5 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, ABOVE(SCR), WITHIN | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, WITHIN(SCR), ABOVE | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, WITHIN(SCR), BELOW | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, WITHIN(SCR), WITHIN | 117 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, WITHIN(SCR), WITHIN | 110 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, WITHIN(SCR), BELOW | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, ABOVE(SCR), ABOVE | 4 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, WITHIN(SCR), ABOVE | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, BELOW(SCR), WITHIN | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, BELOW(SCR), BELOW | 8 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, WITHIN(SCR), ABOVE | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, ABOVE(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, WITHIN(SCR), ABOVE | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, WITHIN(SCR), WITHIN | 114 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, BELOW(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, ABOVE(SCR), ABOVE | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, WITHIN(SCR), BELOW | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, BELOW(SCR), WITHIN | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, BELOW(SCR), BELOW | 5 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, BELOW(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, BELOW(SCR), BELOW | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, ABOVE(SCR), ABOVE | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Platelets, ABOVE(SCR), WITHIN | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, WITHIN(SCR), BELOW | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, WITHIN(SCR), WITHIN | 118 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, ABOVE(SCR), WITHIN | 5 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, WITHIN(SCR), ABOVE | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, WITHIN(SCR), BELOW | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, BELOW(SCR), WITHIN | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, WITHIN(SCR), ABOVE | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, ABOVE(SCR), WITHIN | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, ABOVE(SCR), ABOVE | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, BELOW(SCR), WITHIN | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, ABOVE(SCR), WITHIN | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Neutrophils, ABOVE(SCR), ABOVE | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Hemoglobin, BELOW(SCR), BELOW | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Eosinophils, ABOVE(SCR), ABOVE | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Lymphocytes, WITHIN(SCR), WITHIN | 121 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, WITHIN(SCR), WITHIN | 115 Participants |
Primary
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration \[FDA\] Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline \[e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 31\]. Any corresponding to any grade and Grade 0 to normal ranges.
Time frame: At Day 31
Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 1(SCR), GRADE 1 | 7 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 1(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 1 | 8 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 0 | 111 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 1(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 2(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 2(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Any(SCR), GRADE 0 | 119 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 1(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 0(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 0(SCR), GRADE 0 | 119 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Any(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 0(SCR), GRADE 0 | 119 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 1(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 0(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Any(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Any(SCR), GRADE 0 | 119 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Any(SCR), GRADE 0 | 108 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 0(SCR), GRADE 0 | 118 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Platelets Decrease, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Platelets Decrease, Grade 0(SCR), GRADE 0 | 121 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Any(SCR), GRADE 1 | 11 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 0(SCR), GRADE 0 | 117 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Platelets Decrease, Any(SCR), GRADE 0 | 121 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 2(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Any(SCR), GRADE 2 | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 1(SCR), GRADE 0 | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 1(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 0(SCR), GRADE 0 | 106 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Any(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 1(SCR), GRADE 0 | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Any(SCR), GRADE 0 | 118 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 0(SCR), GRADE 1 | 4 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Any(SCR), GRADE 0 | 120 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 3 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 0(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 1 | 7 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 0 | 109 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 1(SCR), GRADE 0 | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Any(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 3 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Any(SCR), GRADE 0 | 122 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Any(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 0(SCR), GRADE 0 | 122 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 1(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Any(SCR), GRADE 0 | 115 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Any(SCR), GRADE 1 | 7 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Any(SCR), GRADE 2 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 0(SCR), GRADE 0 | 112 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 1(SCR), GRADE 0 | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 1(SCR), GRADE 1 | 6 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 1(SCR), GRADE 2 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 2(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Any(SCR), GRADE 0 | 119 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Any(SCR), GRADE 1 | 5 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 0(SCR), GRADE 0 | 118 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 0(SCR), GRADE 1 | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 1(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 2(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 0 | 115 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 1 | 7 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 2 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 0 | 112 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 1 | 5 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 1(SCR), GRADE 0 | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 1(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 1(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 2(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Platelets Decrease, Any(SCR), GRADE 0 | 124 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Platelets Decrease, Grade 0(SCR), GRADE 0 | 124 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Platelets Decrease, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Any(SCR), GRADE 0 | 122 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Any(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 0(SCR), GRADE 0 | 121 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 0(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Any(SCR), GRADE 0 | 116 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Any(SCR), GRADE 1 | 8 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 0(SCR), GRADE 0 | 115 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 0(SCR), GRADE 1 | 5 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 1(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 1(SCR), GRADE 1 | 7 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 1 | 10 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 1(SCR), GRADE 0 | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 1(SCR), GRADE 0 | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Any(SCR), GRADE 0 | 122 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 0 | 109 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 1 | 10 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 0(SCR), GRADE 0 | 125 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 0(SCR), GRADE 1 | 6 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 3 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 0(SCR), GRADE 0 | 109 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 1(SCR), GRADE 0 | 5 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Any(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 2(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Any(SCR), GRADE 1 | 13 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Any(SCR), GRADE 0 | 125 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Platelets Decrease, Any(SCR), GRADE 0 | 125 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 0(SCR), GRADE 0 | 118 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Platelets Decrease, Grade 0(SCR), GRADE 0 | 125 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Any(SCR), GRADE 0 | 112 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Platelets Decrease, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Any(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Any(SCR), GRADE 0 | 121 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Any(SCR), GRADE 1 | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 0(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 0(SCR), GRADE 0 | 120 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 0(SCR), GRADE 1 | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Any(SCR), GRADE 1 | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 0(SCR), GRADE 0 | 117 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Any(SCR), GRADE 0 | 121 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 0(SCR), GRADE 1 | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 1(SCR), GRADE 0 | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 2(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 0(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 2(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 0 | 114 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Platelets Decrease, Grade 0(SCR), GRADE 0 | 123 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 1(SCR), GRADE 1 | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 2(SCR), GRADE 0 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 1 | 8 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 1(SCR), GRADE 0 | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 0(SCR), GRADE 0 | 123 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 0(SCR), GRADE 0 | 119 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 2 | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 0(SCR), GRADE 0 | 117 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Platelets Decrease, Grade 1(SCR), GRADE 0 | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 1(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 3 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 0(SCR), GRADE 2 | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 1(SCR), GRADE 1 | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Any(SCR), GRADE 0 | 125 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Any(SCR), GRADE 1 | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 0 | 114 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Any(SCR), GRADE 0 | 123 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Any(SCR), GRADE 0 | 122 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 1(SCR), GRADE 2 | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 1 | 4 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 0(SCR), GRADE 1 | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 1(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 0(SCR), GRADE 1 | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 2 | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 1(SCR), GRADE 0 | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 0(SCR), GRADE 0 | 111 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 2(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 0(SCR), GRADE 3 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Grade 1(SCR), GRADE 1 | 5 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 1(SCR), GRADE 0 | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 0(SCR), GRADE 0 | 120 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 1(SCR), GRADE 0 | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Any(SCR), GRADE 2 | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Any(SCR), GRADE 0 | 116 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Grade 0(SCR), GRADE 1 | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 1(SCR), GRADE 1 | 4 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 1(SCR), GRADE 0 | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Increase, Any(SCR), GRADE 1 | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Any(SCR), GRADE 1 | 4 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 1(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Any(SCR), GRADE 1 | 8 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Any(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Grade 1(SCR), GRADE 2 | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Neutrophils Decrease, Grade 2(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 0(SCR), GRADE 1 | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | WBC Decrease, Grade 1(SCR), GRADE 0 | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Any(SCR), GRADE 2 | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Platelets Decrease, Any(SCR), GRADE 0 | 125 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Hemoglobin, Any(SCR), GRADE 0 | 114 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Lymphocytes Decrease, Any(SCR), GRADE 0 | 120 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Eosinophils, Grade 0(SCR), GRADE 1 | 0 Participants |
Primary
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration \[FDA\] Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline \[e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 8\]. Any corresponding to any grade and Grade 0 to normal ranges.
Time frame: At Day 8
Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 0(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Any(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 0(SCR), GRADE 0 | 120 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 0(SCR), GRADE 0 | 106 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Any(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Any(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Any(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 0(SCR), GRADE 1 | 4 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Any(SCR), GRADE 0 | 121 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Any(SCR), GRADE 0 | 120 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 2(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 1(SCR), GRADE 0 | 4 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 1(SCR), GRADE 1 | 7 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Any(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Any(SCR), GRADE 0 | 121 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Grade 0(SCR), GRADE 0 | 121 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Any(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Any(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Any(SCR), GRADE 0 | 121 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 2(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Any(SCR), GRADE 0 | 119 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 1(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 0(SCR), GRADE 0 | 119 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 1(SCR), GRADE 0 | 3 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 1(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 0(SCR), GRADE 1 | 8 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 0(SCR), GRADE 0 | 109 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 1(SCR), GRADE 0 | 2 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 0(SCR), GRADE 0 | 118 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Any(SCR), GRADE 1 | 10 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Any(SCR), GRADE 0 | 112 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Any(SCR), GRADE 0 | 110 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Grade 0(SCR), GRADE 0 | 120 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 2(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Any(SCR), GRADE 1 | 11 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Any(SCR), GRADE 0 | 122 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 0(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 1(SCR), GRADE 0 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 1(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 1(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 1(SCR), GRADE 0 | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Any(SCR), GRADE 0 | 120 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Any(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Any(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 0(SCR), GRADE 0 | 120 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 0(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 1(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Any(SCR), GRADE 0 | 111 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Any(SCR), GRADE 1 | 9 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Any(SCR), GRADE 2 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 0(SCR), GRADE 0 | 107 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 0(SCR), GRADE 1 | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 1(SCR), GRADE 1 | 5 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 1(SCR), GRADE 2 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 2(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Any(SCR), GRADE 0 | 118 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Any(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Any(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 0(SCR), GRADE 0 | 117 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 0(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 1(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 2(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Any(SCR), GRADE 0 | 113 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Any(SCR), GRADE 1 | 5 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Any(SCR), GRADE 2 | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 0(SCR), GRADE 0 | 109 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 0(SCR), GRADE 1 | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 0(SCR), GRADE 2 | 2 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 1(SCR), GRADE 0 | 4 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 1(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 1(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 2(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Any(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Grade 0(SCR), GRADE 0 | 122 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Grade 0(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Any(SCR), GRADE 0 | 119 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Any(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Grade 0(SCR), GRADE 0 | 118 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Grade 0(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Any(SCR), GRADE 0 | 118 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Any(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Any(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 0(SCR), GRADE 0 | 116 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Any(SCR), GRADE 1 | 10 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 1(SCR), GRADE 0 | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Any(SCR), GRADE 0 | 114 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Grade 0(SCR), GRADE 0 | 124 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 2(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Any(SCR), GRADE 0 | 116 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 1(SCR), GRADE 1 | 3 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Any(SCR), GRADE 1 | 8 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 0(SCR), GRADE 1 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Grade 0(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 0(SCR), GRADE 0 | 111 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 0(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 0(SCR), GRADE 1 | 8 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 0(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 0(SCR), GRADE 0 | 124 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 1(SCR), GRADE 0 | 5 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 1(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 1(SCR), GRADE 0 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 2(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Any(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 0(SCR), GRADE 0 | 120 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Any(SCR), GRADE 0 | 125 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Any(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Any(SCR), GRADE 0 | 124 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Any(SCR), GRADE 0 | 121 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Grade 0(SCR), GRADE 0 | 125 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 1(SCR), GRADE 0 | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Grade 0(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Grade 1(SCR), GRADE 0 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 1(SCR), GRADE 1 | 5 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 1(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 2(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 0(SCR), GRADE 1 | 5 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Any(SCR), GRADE 0 | 125 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Any(SCR), GRADE 0 | 122 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Any(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 0(SCR), GRADE 0 | 110 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 1(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Any(SCR), GRADE 2 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Any(SCR), GRADE 1 | 4 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 0(SCR), GRADE 0 | 118 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Any(SCR), GRADE 2 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Any(SCR), GRADE 1 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 0(SCR), GRADE 1 | 2 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 0(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Any(SCR), GRADE 1 | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 1(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 2(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 1(SCR), GRADE 0 | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Any(SCR), GRADE 0 | 110 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Any(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Any(SCR), GRADE 0 | 125 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 1(SCR), GRADE 1 | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Any(SCR), GRADE 0 | 125 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Any(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Any(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 2(SCR), GRADE 0 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 1(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Grade 0(SCR), GRADE 0 | 120 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Any(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Any(SCR), GRADE 0 | 118 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 0(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Any(SCR), GRADE 0 | 122 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 0(SCR), GRADE 0 | 106 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Any(SCR), GRADE 1 | 6 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Grade 0(SCR), GRADE 0 | 123 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Any(SCR), GRADE 0 | 124 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Any(SCR), GRADE 0 | 125 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Any(SCR), GRADE 2 | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 0(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 0(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Grade 0(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 0(SCR), GRADE 0 | 115 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 1(SCR), GRADE 0 | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Grade 0(SCR), GRADE 1 | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 0(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 0(SCR), GRADE 1 | 4 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Grade 0(SCR), GRADE 0 | 123 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 1(SCR), GRADE 0 | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Any(SCR), GRADE 1 | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 0(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Platelets Decrease, Grade 1(SCR), GRADE 0 | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 0(SCR), GRADE 0 | 122 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Lymphocytes Decrease, Grade 0(SCR), GRADE 0 | 120 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 1(SCR), GRADE 0 | 3 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Any(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 1(SCR), GRADE 1 | 5 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 1(SCR), GRADE 0 | 4 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 1(SCR), GRADE 1 | 2 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Grade 1(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Decrease, Grade 1(SCR), GRADE 0 | 4 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Any(SCR), GRADE 1 | 15 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 1(SCR), GRADE 2 | 1 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Eosinophils, Any(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 1(SCR), GRADE 2 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Hemoglobin, Grade 0(SCR), GRADE 1 | 10 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Neutrophils Decrease, Grade 2(SCR), GRADE 1 | 0 Participants |
| Control Group | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | WBC Increase, Any(SCR), GRADE 2 | 0 Participants |
Primary
Number of Subjects With Serious Adverse Events (SAEs) During a 30-day Follow-up Period
Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 1 (vaccination) up to Day 30 (i.e., on the day of vaccination and 29 subsequent days)
Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Formulation 1 Group | Number of Subjects With Serious Adverse Events (SAEs) During a 30-day Follow-up Period | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With Serious Adverse Events (SAEs) During a 30-day Follow-up Period | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With Serious Adverse Events (SAEs) During a 30-day Follow-up Period | 0 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) During a 30-day Follow-up Period | 0 Participants |
Secondary
Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL), calculated on subjects with anti-RSVPreF3 antibody concentration equal to or above the assay cut-off 25 EL.U/mL.
Time frame: At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)
Population: The analysis was performed on the Per-protocol set which included all vaccinated subjects, meeting all protocol requirements and for whom immunogenicity results were available for the specified assay at the corresponding time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV MAT Formulation 1 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 61 | 55170 EL.U/mL |
| RSV MAT Formulation 1 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 8 | 83187 EL.U/mL |
| RSV MAT Formulation 1 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 91 | 39602 EL.U/mL |
| RSV MAT Formulation 1 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 31 | 66153 EL.U/mL |
| RSV MAT Formulation 1 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | PRE | 6753 EL.U/mL |
| RSV MAT Formulation 2 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 31 | 85096 EL.U/mL |
| RSV MAT Formulation 2 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 61 | 65007 EL.U/mL |
| RSV MAT Formulation 2 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 91 | 47629 EL.U/mL |
| RSV MAT Formulation 2 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 8 | 111915 EL.U/mL |
| RSV MAT Formulation 2 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | PRE | 6447 EL.U/mL |
| RSV MAT Formulation 3 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 31 | 94360 EL.U/mL |
| RSV MAT Formulation 3 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | PRE | 6738 EL.U/mL |
| RSV MAT Formulation 3 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 8 | 145984 EL.U/mL |
| RSV MAT Formulation 3 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 61 | 71401 EL.U/mL |
| RSV MAT Formulation 3 Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 91 | 51424 EL.U/mL |
| Control Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 61 | 6100 EL.U/mL |
| Control Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 8 | 5902 EL.U/mL |
| Control Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | PRE | 5583 EL.U/mL |
| Control Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 31 | 5856 EL.U/mL |
| Control Group | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Day 91 | 6692 EL.U/mL |
Secondary
Neutralizing Antibody (Nab) Titers Against RSV Serotype A
Anti RSV-A neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60), calculated on subjects with anti-RSV-A neutralizing antibody titer equal to or above the assay cut-off 18 ED60.
Time frame: At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)
Population: The analysis was performed on the Per-protocol set which included all vaccinated subjects, meeting all protocol requirements and for whom immunogenicity results were available for the specified assay at the corresponding time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV MAT Formulation 1 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 61 | 5268.4 Titers |
| RSV MAT Formulation 1 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 8 | 6720.1 Titers |
| RSV MAT Formulation 1 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 91 | 4110.7 Titers |
| RSV MAT Formulation 1 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 31 | 5327.6 Titers |
| RSV MAT Formulation 1 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | PRE | 851.1 Titers |
| RSV MAT Formulation 2 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 31 | 7323.3 Titers |
| RSV MAT Formulation 2 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 61 | 6783.1 Titers |
| RSV MAT Formulation 2 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 91 | 5186.7 Titers |
| RSV MAT Formulation 2 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 8 | 9843.6 Titers |
| RSV MAT Formulation 2 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | PRE | 921.6 Titers |
| RSV MAT Formulation 3 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 31 | 7943.4 Titers |
| RSV MAT Formulation 3 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | PRE | 868.8 Titers |
| RSV MAT Formulation 3 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 8 | 12638.3 Titers |
| RSV MAT Formulation 3 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 61 | 7575.8 Titers |
| RSV MAT Formulation 3 Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 91 | 5067.9 Titers |
| Control Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 61 | 875.6 Titers |
| Control Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 8 | 790.8 Titers |
| Control Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | PRE | 746.2 Titers |
| Control Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 31 | 762.9 Titers |
| Control Group | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Day 91 | 840.0 Titers |
Secondary
Number of Subjects With SAEs
Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 1 (vaccination) up to Day 91 and up to Day 181
Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Formulation 1 Group | Number of Subjects With SAEs | SAE - Day 181 | 0 Participants |
| RSV MAT Formulation 1 Group | Number of Subjects With SAEs | SAE - Day 91 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With SAEs | SAE - Day 181 | 0 Participants |
| RSV MAT Formulation 2 Group | Number of Subjects With SAEs | SAE - Day 91 | 0 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With SAEs | SAE - Day 181 | 1 Participants |
| RSV MAT Formulation 3 Group | Number of Subjects With SAEs | SAE - Day 91 | 1 Participants |
| Control Group | Number of Subjects With SAEs | SAE - Day 91 | 1 Participants |
| Control Group | Number of Subjects With SAEs | SAE - Day 181 | 2 Participants |