Respiratory Syncytial Virus Infections
Conditions
Keywords
Safety, Respiratory syncytial virus (RSV), Immunogenicity, Reactogenicity, Infants, Vaccine
Brief summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 23 months.
Detailed description
The RSV PED-002 study, designed to evaluate the safety, reactogenicity and immunogenicity of the RSV candidate vaccine when administered in 3 sequential doses to seropositive infants aged 12 to 23 months, will be conducted in an observer-blind manner in Epoch 1 and single-blinded in Epoch 2.
Interventions
BIOLOGICALRSV (GSK3389245A) low dose formulation vaccine
2 doses of 0.5 ml each of RSV (GSK3389245A) low dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
BIOLOGICALRSV (GSK3389245A) middle dose formulation vaccine
2 doses of 0.15 ml each of RSV (GSK3389245A) middle dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
BIOLOGICALRSV (GSK3389245A) high dose formulation vaccine
2 doses of 0.5 ml each of RSV (GSK3389245A) high dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
DRUGPlacebo
2 doses (0.5 mL each for Placebo LD and Placebo HD groups and 0.15 mL each for Placebo MD group) of Placebo administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Observer blind
Eligibility
Sex/Gender
ALL
Age
12 Months to 23 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects' parent(s)/ Legally acceptable representative (LAR\[s\]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure. * A male or female between, and including, 12 and 23 months at the time of the first vaccination. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Seropositive for RSV as determined by IBL International kit. * Born full-term (i.e. after a gestation period of 37 to less than 42 completed weeks) with a minimum birth weight of 2.5 kg. (Required for Spain) * Subjects' parent(s)/LAR(s) need to have access to a consistent mean of telephone contact or computer.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 0), or planned use during the study period. * Any medical condition that in the judgment of the investigator would make IM injection unsafe. * Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine. For corticosteroids, this will mean prednisone, or equivalent. Inhaled and topical steroids are allowed. * Administration of long-acting immune-modifying drugs or planned administration at any time during the study period. * Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period. * Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of scheduled routine pediatric vaccines which may be administered ≥ 14 days before a dose or ≥ 7 days after a dose. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Serious chronic illness. * Major congenital defects. * History of any neurological disorders or seizures. * History of or current autoimmune disease. * History of recurrent wheezing. * History of chronic cough. * Previous hospitalization for respiratory illnesses. * History of thrombocytopenia. * History of anemia. * Previous, current or planned administration of Synagis. * Neurological complications following any prior vaccination. * Born to a mother known or suspected to be HIV-positive. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Family history of congenital or hereditary immunodeficiency. * Previous vaccination with a recombinant simian or human adenoviral vaccine. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Hypersensitivity to latex. * Current severe eczema. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥ 37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route. The preferred route for recording temperature in this study will be axillary. * Clinically significant upper respiratory tract infection * Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator. * Any clinically significant Grade 1 or any ≥ Grade 2 hematological or biochemical laboratory abnormality detected at the last screening blood sampling. * Any other conditions that the investigator judges may interfere with study procedures or findings. * Any conditions that could constitute a risk for the subjects while participating to this study. * Weight below the fifth percentile of the local weight-for-age curve. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. * 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 Any Solicited Local Adverse Events (AEs) | During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31) | Assessed solicited local symptoms are pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Any redness and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters. |
| Number of Subjects With Any Solicited General AEs | During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31) | Assessed solicited general symptoms are drowsiness, fever \[defined as temperature equal to or above (≥) 37.5 degrees Celsius (°C)/99.5 degrees Fahrenheit (°F) for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route, the preferred route for recording temperature in this study being axillary\], irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination. |
| Number of Subjects With Any Unsolicited AEs | During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31) | 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. Unsolicited AEs are 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 study vaccination. |
| Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61 | From Day 1 up to Day 61 | Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination. |
| Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest) | During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31) | Any episode of spontaneous or excessive bleeding if occurring after vaccination was to be fully investigated with a full range of hematological tests to identify the underlying cause and reported as an AE of specific interest. |
| Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | At Day 2 | Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 2\]. |
| 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 hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 8\]. |
| 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 hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 31\]. |
| Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | At Day 32 | Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 32\]. |
| Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | At Day 38 | Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 38\]. |
| Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | At Day 61 | Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 61\]. |
| 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 \[AST\] and creatinine \[CREA\]. Biochemical abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 31\]. |
| Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | At Day 61 | Assessed biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. Biochemical abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 61\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any SAEs From Day 1 up to Day 366 | From Day 1 up to Day 366 | Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination. |
| Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366 | From Dose 1 administration (Day 1) up to Day 366 | Subjects experiencing an LRTI associated with RSV infection were reported as AE of specific interest. To identify RSV-LRTI for the purpose of AE of specific interest, the diagnosis was based on the investigators' clinical judgment taking into account the clinical history, the examination, relevant medical investigations and locally-available diagnostic test for RSV. |
| Palivizumab-competing Antibody Concentrations | At Pre-vaccination (Screening), Day 31 and Day 61 | Humoral response to the investigational RSV vaccine was measured as Palivizumab-competing antibody concentrations and expressed as geometric mean concentrations (GMCs) in microgram/milliliter (µg/mL). |
| Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | From Dose 1 administration (Day 1) up to Day 366 | RSV-RTI refers to subject having runny nose OR blocked nose OR cough AND confirmed RSV infection \[RSV infection confirmed on nasal swab positive for RSV A or B by quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) performed at sponsor level\]. RSV-LRTI refers to subject with history of cough OR difficulty breathing \[based on history reported by parents/legally acceptable representatives (LARs) and includes difficulty breathing (e.g. showing signs of wheezing or stridor, tachypnoea, flaring of nostrils, chest in-drawing, apnoea) associated with nasal obstruction\] AND Blood Oxygen Saturation (SpO2) lower than (\<) 95 percent (%), OR respiratory rate (RR) increase \[defined as ≥ 40/minute (12 months of age or above)\] AND confirmed RSV infection. RSV-severe LRTI are cases meeting the case definition of RSV-LRTI AND SpO2 \< 93%, OR lower chest wall in-drawing. |
| Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731 | From Day 1 up to study conclusion at Day 731 | Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination. |
| Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | From Dose 1 administration (Day 1) up to study conclusion at Day 731 | Subjects experiencing an LRTI associated with RSV infection were reported as AE of specific interest. To identify RSV-LRTI for the purpose of AE of specific interest, the diagnosis was based on the investigators' clinical judgment taking into account the clinical history, the examination, relevant medical investigations and locally-available diagnostic test for RSV. |
| Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | From Dose 1 administration (Day 1) up to study conclusion at Day 731 | RSV-RTI refers to subject having runny nose OR blocked nose OR cough AND confirmed RSV infection (RSV infection confirmed on nasal swab positive for RSV A or B by qRT-PCR performed at sponsor level). RSV-LRTI refers to subject with history of cough OR difficulty breathing \[based on history reported by parents/LARs and includes difficulty breathing (e.g. showing signs of wheezing or stridor, tachypnoea, flaring of nostrils, chest in-drawing, apnoea) associated with nasal obstruction\] AND Sp02 \< 95% OR respiratory rate (RR) increase \[defined as ≥ 40/minute (12 months of age or above)\] AND confirmed RSV infection. RSV-severe LRTI are cases meeting the case definition of RSV-LRTI AND SpO2 \< 93%, OR lower chest wall in-drawing. |
| Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | At Pre-vaccination (Screening), Day 31, Day 61 and Day 366 | Magnitude of cell mediated immunity (CMI) response to the investigational RSV vaccine was measured in terms of frequency of RSV-specific CD4+ T-cells expressing at least two markers upon stimulation with F, N and M2-1 peptide pools and expressed in RSV-specific CD4+ T-cells/million cells. Assessed markers were CD40-L, IL-2, TNF-α and IFN-ɣ. |
| Anti-RSV-A Neutralizing Antibody Titers | At Pre-vaccination (Screening), Day 31, Day 61 and Day 366 | Humoral response to the investigational RSV vaccine was measured in terms of anti-RSV-A neutralizing antibody titers and expressed as geometric mean titers (GMTs) in Estimated Dilution 60 (ED60) titers. |
| Anti-RSV-F Antibody Concentrations | At Pre-vaccination (Screening), Day 31, Day 61 and Day 366 | Humoral response to the investigational RSV vaccine was measured as anti-RSV F antibody concentrations and expressed as geometric mean concentrations (GMCs) in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL). |
Countries
Canada, Italy, Mexico, Panama, Poland, Spain, Taiwan, United States
Participant flow
Recruitment details
The study was conducted at 32 centers in 8 countries (Canada, Italy, Mexico, Panama, Poland, Spain, Taiwan and United States).
Pre-assignment details
Out of 107 participants enrolled in the study, 21 participants were not assigned to any study group and 4 participants did not receive any study treatment. 82 subjects were vaccinated and included in the Exposed Set.
Participants by arm
| Arm | Count |
|---|---|
| RSV LD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31. | 11 |
| RSV MD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31. | 14 |
| RSV HD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31. | 18 |
| Placebo LD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31. | 11 |
| Placebo MD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31. | 11 |
| Placebo HD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31. | 17 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | MIGRATED / MOVED FROM THE STUDY AREA | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | PARENTS NOT ABLE TO COME TO SITE | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | PARENTS REFUSED SAFETY FOLLOW-UP | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | SUBJECT WITHDRAWN AT AN INTERIM TIMEPOINT, BUT ACCEPTED CALLS FOR SAFETY SURVEILLANCE | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo HD Group | Total | RSV LD Group | RSV MD Group | RSV HD Group | Placebo LD Group | Placebo MD Group |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 17.4 MONTHS STANDARD_DEVIATION 3.8 | 16.1 MONTHS STANDARD_DEVIATION 3.2 | 15.4 MONTHS STANDARD_DEVIATION 1.6 | 15.6 MONTHS STANDARD_DEVIATION 3.3 | 16.3 MONTHS STANDARD_DEVIATION 4 | 15.0 MONTHS STANDARD_DEVIATION 1.9 | 16.2 MONTHS STANDARD_DEVIATION 2.7 |
| Race/Ethnicity, Customized AFRICAN HERITAGE / AFRICAN AMERICAN | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized ASIAN - EAST ASIAN HERITAGE | 3 Participants | 7 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized ASIAN - SOUTH EAST ASIAN HERITAGE | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized OTHER, NOT SPECIFIED | 9 Participants | 34 Participants | 0 Participants | 7 Participants | 12 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized WHITE - CAUCASIAN / EUROPEAN HERITAGE | 5 Participants | 37 Participants | 11 Participants | 6 Participants | 2 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Female | 12 Participants | 41 Participants | 4 Participants | 7 Participants | 10 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 41 Participants | 7 Participants | 7 Participants | 8 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 14 | 0 / 18 | 0 / 11 | 0 / 11 | 0 / 17 |
| other Total, other adverse events | 10 / 11 | 11 / 14 | 17 / 18 | 11 / 11 | 10 / 11 | 14 / 17 |
| serious Total, serious adverse events | 1 / 11 | 1 / 14 | 2 / 18 | 3 / 11 | 1 / 11 | 2 / 17 |
Outcome results
Primary
Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61
Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.
Time frame: From Day 1 up to Day 61
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV LD Group | Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61 | 0 Participants |
| RSV MD Group | Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61 | 0 Participants |
| RSV HD Group | Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61 | 1 Participants |
| Placebo LD Group | Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61 | 1 Participants |
| Placebo MD Group | Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61 | 0 Participants |
| Placebo HD Group | Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61 | 2 Participants |
Primary
Number of Subjects With Any Solicited General AEs
Assessed solicited general symptoms are drowsiness, fever \[defined as temperature equal to or above (≥) 37.5 degrees Celsius (°C)/99.5 degrees Fahrenheit (°F) for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route, the preferred route for recording temperature in this study being axillary\], irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.
Time frame: During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with the diary card completed after each vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV LD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Loss Of Appetite | 3 Participants |
| RSV LD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Irritability / Fussiness | 3 Participants |
| RSV LD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Drowsiness | 4 Participants |
| RSV LD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Fever | 3 Participants |
| RSV LD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Drowsiness | 2 Participants |
| RSV LD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Irritability / Fussiness | 3 Participants |
| RSV LD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Loss Of Appetite | 3 Participants |
| RSV LD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Fever | 2 Participants |
| RSV MD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Fever | 3 Participants |
| RSV MD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Fever | 2 Participants |
| RSV MD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Drowsiness | 2 Participants |
| RSV MD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Loss Of Appetite | 0 Participants |
| RSV MD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Irritability / Fussiness | 1 Participants |
| RSV MD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Loss Of Appetite | 3 Participants |
| RSV MD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Irritability / Fussiness | 3 Participants |
| RSV MD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Drowsiness | 1 Participants |
| RSV HD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Irritability / Fussiness | 4 Participants |
| RSV HD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Loss Of Appetite | 4 Participants |
| RSV HD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Fever | 10 Participants |
| RSV HD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Fever | 5 Participants |
| RSV HD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Drowsiness | 5 Participants |
| RSV HD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Irritability / Fussiness | 5 Participants |
| RSV HD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Loss Of Appetite | 6 Participants |
| RSV HD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Drowsiness | 4 Participants |
| Placebo LD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Loss Of Appetite | 3 Participants |
| Placebo LD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Irritability / Fussiness | 3 Participants |
| Placebo LD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Drowsiness | 3 Participants |
| Placebo LD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Drowsiness | 5 Participants |
| Placebo LD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Loss Of Appetite | 2 Participants |
| Placebo LD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Fever | 3 Participants |
| Placebo LD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Fever | 1 Participants |
| Placebo LD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Irritability / Fussiness | 4 Participants |
| Placebo MD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Fever | 2 Participants |
| Placebo MD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Drowsiness | 3 Participants |
| Placebo MD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Drowsiness | 2 Participants |
| Placebo MD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Irritability / Fussiness | 1 Participants |
| Placebo MD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Loss Of Appetite | 2 Participants |
| Placebo MD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Irritability / Fussiness | 2 Participants |
| Placebo MD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Loss Of Appetite | 2 Participants |
| Placebo MD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Fever | 2 Participants |
| Placebo HD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Fever | 1 Participants |
| Placebo HD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Drowsiness | 5 Participants |
| Placebo HD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Loss Of Appetite | 3 Participants |
| Placebo HD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Fever | 0 Participants |
| Placebo HD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Irritability / Fussiness | 6 Participants |
| Placebo HD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Irritability / Fussiness | 2 Participants |
| Placebo HD Group | Number of Subjects With Any Solicited General AEs | DOSE 2, Any Loss Of Appetite | 5 Participants |
| Placebo HD Group | Number of Subjects With Any Solicited General AEs | DOSE 1, Any Drowsiness | 4 Participants |
Primary
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Assessed solicited local symptoms are pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Any redness and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
Time frame: During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with the diary card completed after each vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV LD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Pain | 1 Participants |
| RSV LD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Redness | 2 Participants |
| RSV LD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Swelling | 0 Participants |
| RSV LD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Pain | 2 Participants |
| RSV LD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Redness | 2 Participants |
| RSV LD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Swelling | 0 Participants |
| RSV MD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Redness | 1 Participants |
| RSV MD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Pain | 2 Participants |
| RSV MD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Swelling | 0 Participants |
| RSV MD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Pain | 2 Participants |
| RSV MD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Swelling | 0 Participants |
| RSV MD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Redness | 1 Participants |
| RSV HD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Swelling | 0 Participants |
| RSV HD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Redness | 2 Participants |
| RSV HD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Pain | 2 Participants |
| RSV HD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Swelling | 1 Participants |
| RSV HD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Pain | 0 Participants |
| RSV HD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Redness | 3 Participants |
| Placebo LD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Pain | 1 Participants |
| Placebo LD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Redness | 3 Participants |
| Placebo LD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Swelling | 1 Participants |
| Placebo LD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Swelling | 1 Participants |
| Placebo LD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Redness | 3 Participants |
| Placebo LD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Pain | 2 Participants |
| Placebo MD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Pain | 0 Participants |
| Placebo MD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Redness | 0 Participants |
| Placebo MD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Redness | 0 Participants |
| Placebo MD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Swelling | 1 Participants |
| Placebo MD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Pain | 0 Participants |
| Placebo MD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Swelling | 0 Participants |
| Placebo HD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Pain | 3 Participants |
| Placebo HD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Swelling | 2 Participants |
| Placebo HD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Redness | 2 Participants |
| Placebo HD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 2, Any Swelling | 2 Participants |
| Placebo HD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Redness | 3 Participants |
| Placebo HD Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | DOSE 1, Any Pain | 2 Participants |
Primary
Number of Subjects With Any Unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AEs are 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 study vaccination.
Time frame: During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV LD Group | Number of Subjects With Any Unsolicited AEs | 9 Participants |
| RSV MD Group | Number of Subjects With Any Unsolicited AEs | 9 Participants |
| RSV HD Group | Number of Subjects With Any Unsolicited AEs | 13 Participants |
| Placebo LD Group | Number of Subjects With Any Unsolicited AEs | 7 Participants |
| Placebo MD Group | Number of Subjects With Any Unsolicited AEs | 10 Participants |
| Placebo HD Group | Number of Subjects With Any Unsolicited AEs | 13 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 \[AST\] and creatinine \[CREA\]. Biochemical abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 31\].
Time frame: At Day 31
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Below | 4 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Within | 1 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Below | 1 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Within | 1 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Within | 9 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Below | 3 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Below | 1 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Within | 3 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Within | 7 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Below | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Above | 1 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Within | 7 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Within | 1 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Below | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Above, Within | 1 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Above, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Below | 1 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Unknown | 1 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Within | 7 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Below | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Unknown | 1 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Below | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Above | 2 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Below | 3 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Unknown | 1 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Within | 10 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Below | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Within | 13 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Below | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Within | 10 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Within | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Below | 4 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Within | 3 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Below | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Below | 1 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Within | 15 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Above, Within | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Above | 2 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Above, Within | 1 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Above | 2 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Above, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Within | 1 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Unknown | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Unknown | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Within | 11 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Above, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Unknown | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Within | 9 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Above | 1 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Within | 1 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Below | 7 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Within | 1 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Within | 3 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Above, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Unknown | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Unknown | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Below | 1 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Within | 7 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Above, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Above, Within | 1 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Within | 7 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Above, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Above | 2 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Within | 7 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Within | 12 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Above, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Above, Within | 2 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Above | 2 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Within | 13 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Below | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Below | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Within, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Below, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Within, Below | 4 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | ALT, Below, Below | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | CREA, Above, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Within | 14 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Above, Below | 1 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | AST, Within, Unknown | 0 Participants |
Primary
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61
Assessed biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. Biochemical abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 61\].
Time frame: At Day 61
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Below | 3 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Below, Within | 3 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Below, Within | 1 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Above, Within | 1 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Within, Within | 8 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Below, Below | 1 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Below, Below | 4 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Within, Within | 9 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Above, Above | 1 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Above, Within | 1 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Within, Above | 1 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Below | 1 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Above, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Within, Above | 1 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Below, Below | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Within | 8 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Below, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Below, Within | 1 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Above, Within | 1 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Within, Within | 10 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Within, Within | 9 Participants |
| RSV MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Below, Below | 2 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Below, Below | 2 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Below, Within | 2 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Below | 3 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Below, Below | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Within, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Below, Within | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Above, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Above, Within | 2 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Within, Within | 15 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Within, Within | 15 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Above, Within | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Within, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Above, Within | 1 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Above, Above | 2 Participants |
| RSV HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Within | 10 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Above, Above | 1 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Within, Above | 1 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Above, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Below, Below | 7 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Within | 3 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Below, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Above, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Below, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Above, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Within, Within | 10 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Below, Within | 1 Participants |
| Placebo LD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Within, Within | 10 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Within | 8 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Below, Within | 1 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Below, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Below, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Within, Within | 9 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Within, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Above, Within | 1 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Above, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Within, Within | 8 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Within, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Above, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Above, Above | 2 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Below, Below | 1 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Above, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Below, Below | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Above, Above | 2 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Above, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Above, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Within | 15 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Above, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Within, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Within, Within | 12 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Below, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Above, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | ALT, Below, Below | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Within, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | AST, Within, Within | 13 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Within, Below | 1 Participants |
| Placebo HD Group | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | CREA, Below, Within | 0 Participants |
Primary
Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest)
Any episode of spontaneous or excessive bleeding if occurring after vaccination was to be fully investigated with a full range of hematological tests to identify the underlying cause and reported as an AE of specific interest.
Time frame: During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV LD Group | Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest) | 0 Participants |
| RSV MD Group | Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest) | 0 Participants |
| RSV HD Group | Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest) | 0 Participants |
| Placebo LD Group | Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest) | 0 Participants |
| Placebo MD Group | Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest) | 0 Participants |
| Placebo HD Group | Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest) | 0 Participants |
Primary
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2
Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 2\].
Time frame: At Day 2
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Below, Below | 3 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Below | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Within | 8 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Below, Below | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Below, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Below | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Within | 11 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Below | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Within | 10 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Above, Within | 1 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Below | 2 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Below, Below | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Within | 9 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Above, Within | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Unknown | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Below, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Unknown | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Below, Below | 2 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Within | 10 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Below | 2 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Above, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Above | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Below | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Unknown | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Above, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Within | 11 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Within | 15 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Above | 2 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Above, Within | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Above, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Below, Below | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Below, Within | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Below | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Above, Within | 2 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Within | 13 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Above, Within | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Above, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Below | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Above, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Within | 12 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Below, Below | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Within | 9 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Unknown | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Above, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Unknown | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Within | 10 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Above, Within | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Below, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Below, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Within | 11 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Below, Below | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Above, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Unknown | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Above, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Within | 9 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Unknown | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Within | 6 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Above, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Above, Within | 2 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Above, Within | 2 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Above, Above | 2 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Unknown | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Above, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Below | 2 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Below, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Within | 4 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Below, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Above, Above | 3 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Below, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Unknown | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Above | 2 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Above, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Above, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Above, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Within | 12 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Below, Below | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Above | 3 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Below, Below | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Within | 13 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Above, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Below | 2 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Above, Above | 2 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Above, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Within | 13 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Below, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | PLC, Within, Below | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | WBC, Within, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 | HgL, Within, Below | 2 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 hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 31\].
Time frame: At Day 31
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Within | 9 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Below, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Below, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Below, Below | 3 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Below | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Below | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Within | 10 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Within | 7 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Above | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Below | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Below, Within | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Above | 2 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Above, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Below | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Below, Below | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Within | 9 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Below, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Unknown | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Unknown | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Above, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Within | 9 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Within | 8 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Above | 2 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Unknown | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Above, Within | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Below | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Above, Within | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Above | 2 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Above, Within | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Above, Within | 2 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Below, Below | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Below, Within | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Above, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Below, Within | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Below | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Within | 13 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Above, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Within | 15 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Within | 15 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Above | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Below, Below | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Above, Within | 2 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Within | 9 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Above, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Below, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Unknown | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Within | 10 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Above, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Unknown | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Within | 8 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Below, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Unknown | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Below, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Below | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Above, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Below, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Above, Within | 2 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Within | 4 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Below, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Within | 4 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Within | 8 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Unknown | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Above, Within | 3 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Unknown | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Unknown | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Above, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Above, Above | 2 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Above, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Within | 13 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Within | 15 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Above | 2 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Below | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Above, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Below, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Above, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Above, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Below, Below | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Within | 14 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Below, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Above, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | HgL, Within, Below | 2 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | PLC, Within, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | WBC, Within, Above | 0 Participants |
Primary
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32
Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 32\].
Time frame: At Day 32
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Below, Within | 1 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Within | 6 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Below | 1 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Below | 1 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Within | 10 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Below, Below | 2 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Below | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Below, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Within | 9 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Above, Within | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Above, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Below, Below | 2 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Below | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Unknown | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Below, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Below, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Unknown | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Below | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Within | 7 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Above, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Above | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Unknown | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Below | 2 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Within | 7 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Within | 7 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Below, Within | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Above, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Within | 11 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Above, Within | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Above, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Below, Below | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Below, Within | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Above, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Above, Within | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Below | 3 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Within | 15 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Below | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Below | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Above, Within | 2 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Within | 14 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Unknown | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Above, Within | 2 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Below, Below | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Within | 10 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Unknown | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Above, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Above | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Below, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Within | 9 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Within | 7 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Below, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Unknown | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Above, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Unknown | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Within | 8 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Above, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Unknown | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Below, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Below, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Below | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Above, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Below, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Unknown | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Below | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Within | 5 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Above, Within | 2 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Above, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Within | 4 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Above, Within | 4 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Above, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Within | 14 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Below | 2 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Within | 14 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Within, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Below, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Above, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Above, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Within | 14 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Below | 2 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Within, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Above, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Above, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Below, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | HgL, Below, Below | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Above, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | WBC, Above, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 | PLC, Within, Below | 0 Participants |
Primary
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38
Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 38\].
Time frame: At Day 38
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.~As per Protocol, hematology testing for RSV HD group on Day 38 was not performed since no platelet decrease (i.e. less than 150000 cells/cubic millimeter) was detected on Day 32.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Within, Within | 6 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Within, Above | 1 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Within, Within | 8 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Within, Within | 7 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Below, Below | 2 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Within, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Within, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Within, Within | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Below, Below | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Within, Within | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Within, Within | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Below, Below | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Above, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Above, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Within, Within | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Within, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Within, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Above, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Within, Within | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Within, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Within, Within | 4 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Within, Within | 5 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Within, Above | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Below, Below | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Within, Above | 2 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Within, Within | 5 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Below, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Within, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Within, Within | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Above, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Within, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Within, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Within, Within | 2 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Above, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Above, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Above, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Below, Below | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Within, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | HgL, Above, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Within, Within | 2 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Within, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | WBC, Above, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Within, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 | PLC, Within, Within | 1 Participants |
Primary
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61
Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 61\].
Time frame: At Day 61
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Below, Below | 2 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Within | 9 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Above | 1 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Below | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Below, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Below | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Below, Within | 1 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Below | 1 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Unknown | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Within | 9 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Within | 7 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Within | 8 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Below, Below | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Unknown | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Below, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Unknown | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Within | 11 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Below | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Below | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Below, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Below | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Above, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Unknown | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Above | 3 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Above, Within | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Above | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Above, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Within | 10 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Above, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Below, Within | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Below | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Within | 15 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Above, Within | 2 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Above, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Below, Below | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Below, Within | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Unknown | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Below | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Within | 16 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Above, Within | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Above, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Below | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Within | 14 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Above, Within | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Above, Above | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Above, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Within | 8 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Above | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Below, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Within | 8 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Within | 4 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Unknown | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Below | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Below, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Above, Within | 2 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Unknown | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Above, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Unknown | 1 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Below, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Above, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Above, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Within | 11 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Above, Within | 4 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Above, Within | 4 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Above, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Above, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Below, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Unknown | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Unknown | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Within | 5 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Above | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Below, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Below, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Within | 6 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Below, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Below, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Within | 10 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Below | 2 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Above | 5 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Above, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Above, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Above, Within | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Above | 2 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Below, Below | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Below | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Above, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Within | 13 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Within | 8 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Above, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Above, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | HgL, Within, Unknown | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | WBC, Within, Below | 3 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 | PLC, Within, Unknown | 0 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 hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 8\].
Time frame: At Day 8
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Within, Within | 8 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Above, Within | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Below, Below | 2 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Within, Above | 1 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Above, Within | 1 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Within, Within | 7 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Within, Above | 1 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Above, Above | 0 Participants |
| RSV LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Within, Within | 7 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Above, Within | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Within, Within | 3 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Below, Below | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Within, Within | 2 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Above, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Within, Above | 1 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Within, Within | 2 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Within, Above | 0 Participants |
| RSV MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Above, Within | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Within, Within | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Within, Above | 1 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Within, Within | 2 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Above, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Above, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Below, Below | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Within, Within | 2 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Within, Above | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Above, Within | 0 Participants |
| RSV HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Above, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Above, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Within, Within | 8 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Above, Within | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Above, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Within, Within | 8 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Within, Within | 7 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Within, Above | 0 Participants |
| Placebo LD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Below, Below | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Above, Within | 1 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Below, Below | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Within, Within | 5 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Above, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Within, Within | 2 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Within, Above | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Above, Within | 3 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Within, Within | 0 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Within, Above | 3 Participants |
| Placebo MD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Above, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Above, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Within, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Within, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Above, Within | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | WBC, Within, Within | 3 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Above, Above | 1 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Within, Within | 2 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | HgL, Below, Below | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Above, Above | 0 Participants |
| Placebo HD Group | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | PLC, Within, Within | 3 Participants |
Secondary
Anti-RSV-A Neutralizing Antibody Titers
Humoral response to the investigational RSV vaccine was measured in terms of anti-RSV-A neutralizing antibody titers and expressed as geometric mean titers (GMTs) in Estimated Dilution 60 (ED60) titers.
Time frame: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366
Population: This analysis was performed on the Per-protocol set (PPS), which included all vaccinated subjects, meeting all protocol requirements and with available immunogenicity results for the specified assay and time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV LD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 61 | 1081.3 Titers |
| RSV LD Group | Anti-RSV-A Neutralizing Antibody Titers | Screening | 127.4 Titers |
| RSV LD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 31 | 711.7 Titers |
| RSV LD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 366 | 236.9 Titers |
| RSV MD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 61 | 1809 Titers |
| RSV MD Group | Anti-RSV-A Neutralizing Antibody Titers | Screening | 179.4 Titers |
| RSV MD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 366 | 837 Titers |
| RSV MD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 31 | 1646 Titers |
| RSV HD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 31 | 2203.9 Titers |
| RSV HD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 366 | 1038 Titers |
| RSV HD Group | Anti-RSV-A Neutralizing Antibody Titers | Screening | 495.7 Titers |
| RSV HD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 61 | 1974.9 Titers |
| Placebo LD Group | Anti-RSV-A Neutralizing Antibody Titers | Screening | 376.5 Titers |
| Placebo LD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 366 | 398.5 Titers |
| Placebo LD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 31 | 645.9 Titers |
| Placebo LD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 61 | 421.5 Titers |
| Placebo MD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 31 | 703.9 Titers |
| Placebo MD Group | Anti-RSV-A Neutralizing Antibody Titers | Screening | 214.6 Titers |
| Placebo MD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 61 | 316.4 Titers |
| Placebo MD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 366 | 545.4 Titers |
| Placebo HD Group | Anti-RSV-A Neutralizing Antibody Titers | Screening | 332 Titers |
| Placebo HD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 31 | 295 Titers |
| Placebo HD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 366 | 493.8 Titers |
| Placebo HD Group | Anti-RSV-A Neutralizing Antibody Titers | Day 61 | 307.1 Titers |
Secondary
Anti-RSV-F Antibody Concentrations
Humoral response to the investigational RSV vaccine was measured as anti-RSV F antibody concentrations and expressed as geometric mean concentrations (GMCs) in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).
Time frame: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366
Population: This analysis was performed on the Per-protocol set (PPS), which included all vaccinated subjects, meeting all protocol requirements and with available immunogenicity results for the specified assay and time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV LD Group | Anti-RSV-F Antibody Concentrations | Screening | 2082 EU/mL |
| RSV LD Group | Anti-RSV-F Antibody Concentrations | Day 31 | 4807.2 EU/mL |
| RSV LD Group | Anti-RSV-F Antibody Concentrations | Day 366 | 3988.5 EU/mL |
| RSV LD Group | Anti-RSV-F Antibody Concentrations | Day 61 | 6167.5 EU/mL |
| RSV MD Group | Anti-RSV-F Antibody Concentrations | Day 31 | 10810.9 EU/mL |
| RSV MD Group | Anti-RSV-F Antibody Concentrations | Day 366 | 6521.1 EU/mL |
| RSV MD Group | Anti-RSV-F Antibody Concentrations | Day 61 | 15577.4 EU/mL |
| RSV MD Group | Anti-RSV-F Antibody Concentrations | Screening | 2061.6 EU/mL |
| RSV HD Group | Anti-RSV-F Antibody Concentrations | Day 366 | 6490.7 EU/mL |
| RSV HD Group | Anti-RSV-F Antibody Concentrations | Day 61 | 15083.8 EU/mL |
| RSV HD Group | Anti-RSV-F Antibody Concentrations | Screening | 3686.4 EU/mL |
| RSV HD Group | Anti-RSV-F Antibody Concentrations | Day 31 | 17419 EU/mL |
| Placebo LD Group | Anti-RSV-F Antibody Concentrations | Day 366 | 3591.3 EU/mL |
| Placebo LD Group | Anti-RSV-F Antibody Concentrations | Day 61 | 2983.3 EU/mL |
| Placebo LD Group | Anti-RSV-F Antibody Concentrations | Day 31 | 6134.2 EU/mL |
| Placebo LD Group | Anti-RSV-F Antibody Concentrations | Screening | 3933.2 EU/mL |
| Placebo MD Group | Anti-RSV-F Antibody Concentrations | Screening | 1216.3 EU/mL |
| Placebo MD Group | Anti-RSV-F Antibody Concentrations | Day 31 | 7911.6 EU/mL |
| Placebo MD Group | Anti-RSV-F Antibody Concentrations | Day 61 | 3182 EU/mL |
| Placebo MD Group | Anti-RSV-F Antibody Concentrations | Day 366 | 3047.5 EU/mL |
| Placebo HD Group | Anti-RSV-F Antibody Concentrations | Day 31 | 2350.6 EU/mL |
| Placebo HD Group | Anti-RSV-F Antibody Concentrations | Screening | 2988.6 EU/mL |
| Placebo HD Group | Anti-RSV-F Antibody Concentrations | Day 366 | 4487.9 EU/mL |
| Placebo HD Group | Anti-RSV-F Antibody Concentrations | Day 61 | 2101.3 EU/mL |
Secondary
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools
Magnitude of cell mediated immunity (CMI) response to the investigational RSV vaccine was measured in terms of frequency of RSV-specific CD4+ T-cells expressing at least two markers upon stimulation with F, N and M2-1 peptide pools and expressed in RSV-specific CD4+ T-cells/million cells. Assessed markers were CD40-L, IL-2, TNF-α and IFN-ɣ.
Time frame: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366
Population: This analysis was performed on the Per-protocol set (PPS), which included all vaccinated subjects, meeting all protocol requirements and with available CMI results at the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| RSV LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Screening | 51 RSV-specific CD4+ T-cells/million cells |
| RSV LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 31 | 1 RSV-specific CD4+ T-cells/million cells |
| RSV LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 61 | 70 RSV-specific CD4+ T-cells/million cells |
| RSV LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 31 | 129.5 RSV-specific CD4+ T-cells/million cells |
| RSV LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 366 | 7 RSV-specific CD4+ T-cells/million cells |
| RSV LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 31 | 291 RSV-specific CD4+ T-cells/million cells |
| RSV LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Screening | 169.5 RSV-specific CD4+ T-cells/million cells |
| RSV LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 61 | 8 RSV-specific CD4+ T-cells/million cells |
| RSV LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 61 | 214 RSV-specific CD4+ T-cells/million cells |
| RSV LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Screening | 1 RSV-specific CD4+ T-cells/million cells |
| RSV LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 366 | 206 RSV-specific CD4+ T-cells/million cells |
| RSV LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 366 | 56 RSV-specific CD4+ T-cells/million cells |
| RSV MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 366 | 41.5 RSV-specific CD4+ T-cells/million cells |
| RSV MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 61 | 451 RSV-specific CD4+ T-cells/million cells |
| RSV MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 31 | 21.5 RSV-specific CD4+ T-cells/million cells |
| RSV MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 31 | 229 RSV-specific CD4+ T-cells/million cells |
| RSV MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Screening | 1 RSV-specific CD4+ T-cells/million cells |
| RSV MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 366 | 2.5 RSV-specific CD4+ T-cells/million cells |
| RSV MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Screening | 54 RSV-specific CD4+ T-cells/million cells |
| RSV MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 61 | 144 RSV-specific CD4+ T-cells/million cells |
| RSV MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 31 | 546 RSV-specific CD4+ T-cells/million cells |
| RSV MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 366 | 108.5 RSV-specific CD4+ T-cells/million cells |
| RSV MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 61 | 2 RSV-specific CD4+ T-cells/million cells |
| RSV MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Screening | 123 RSV-specific CD4+ T-cells/million cells |
| RSV HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 61 | 394 RSV-specific CD4+ T-cells/million cells |
| RSV HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Screening | 1 RSV-specific CD4+ T-cells/million cells |
| RSV HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 31 | 1086 RSV-specific CD4+ T-cells/million cells |
| RSV HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 366 | 1164 RSV-specific CD4+ T-cells/million cells |
| RSV HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Screening | 140 RSV-specific CD4+ T-cells/million cells |
| RSV HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 31 | 289 RSV-specific CD4+ T-cells/million cells |
| RSV HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 61 | 1 RSV-specific CD4+ T-cells/million cells |
| RSV HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 366 | 82 RSV-specific CD4+ T-cells/million cells |
| RSV HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Screening | 56 RSV-specific CD4+ T-cells/million cells |
| RSV HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 31 | 229 RSV-specific CD4+ T-cells/million cells |
| RSV HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 61 | 46 RSV-specific CD4+ T-cells/million cells |
| RSV HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 366 | 13 RSV-specific CD4+ T-cells/million cells |
| Placebo LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 61 | 71 RSV-specific CD4+ T-cells/million cells |
| Placebo LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 366 | 252.5 RSV-specific CD4+ T-cells/million cells |
| Placebo LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Screening | 176 RSV-specific CD4+ T-cells/million cells |
| Placebo LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 366 | 89 RSV-specific CD4+ T-cells/million cells |
| Placebo LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 61 | 105.5 RSV-specific CD4+ T-cells/million cells |
| Placebo LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Screening | 1 RSV-specific CD4+ T-cells/million cells |
| Placebo LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 366 | 23 RSV-specific CD4+ T-cells/million cells |
| Placebo LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 31 | 1 RSV-specific CD4+ T-cells/million cells |
| Placebo LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 31 | 234 RSV-specific CD4+ T-cells/million cells |
| Placebo LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 61 | 30 RSV-specific CD4+ T-cells/million cells |
| Placebo LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 31 | 58 RSV-specific CD4+ T-cells/million cells |
| Placebo LD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Screening | 104 RSV-specific CD4+ T-cells/million cells |
| Placebo MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Screening | 253 RSV-specific CD4+ T-cells/million cells |
| Placebo MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 61 | 1 RSV-specific CD4+ T-cells/million cells |
| Placebo MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 61 | 759 RSV-specific CD4+ T-cells/million cells |
| Placebo MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Screening | 1813 RSV-specific CD4+ T-cells/million cells |
| Placebo MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Screening | 214 RSV-specific CD4+ T-cells/million cells |
| Placebo MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 31 | 145.5 RSV-specific CD4+ T-cells/million cells |
| Placebo MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 61 | 64.5 RSV-specific CD4+ T-cells/million cells |
| Placebo MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 366 | 664.5 RSV-specific CD4+ T-cells/million cells |
| Placebo MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 31 | 1129.5 RSV-specific CD4+ T-cells/million cells |
| Placebo MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 31 | 193 RSV-specific CD4+ T-cells/million cells |
| Placebo MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 366 | 48 RSV-specific CD4+ T-cells/million cells |
| Placebo MD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 366 | 78 RSV-specific CD4+ T-cells/million cells |
| Placebo HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV F pool 15/11 Ag, Day 366 | 229 RSV-specific CD4+ T-cells/million cells |
| Placebo HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV M2-1 pool 15/11 Ag, Day 366 | 56 RSV-specific CD4+ T-cells/million cells |
| Placebo HD Group | Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools | RSV N pool 15/11 Ag, Day 366 | 91 RSV-specific CD4+ T-cells/million cells |
Secondary
Number of Subjects With Any SAEs From Day 1 up to Day 366
Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.
Time frame: From Day 1 up to Day 366
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV LD Group | Number of Subjects With Any SAEs From Day 1 up to Day 366 | 1 Participants |
| RSV MD Group | Number of Subjects With Any SAEs From Day 1 up to Day 366 | 1 Participants |
| RSV HD Group | Number of Subjects With Any SAEs From Day 1 up to Day 366 | 1 Participants |
| Placebo LD Group | Number of Subjects With Any SAEs From Day 1 up to Day 366 | 3 Participants |
| Placebo MD Group | Number of Subjects With Any SAEs From Day 1 up to Day 366 | 1 Participants |
| Placebo HD Group | Number of Subjects With Any SAEs From Day 1 up to Day 366 | 2 Participants |
Secondary
Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731
Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.
Time frame: From Day 1 up to study conclusion at Day 731
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV LD Group | Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731 | 1 Participants |
| RSV MD Group | Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731 | 1 Participants |
| RSV HD Group | Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731 | 2 Participants |
| Placebo LD Group | Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731 | 3 Participants |
| Placebo MD Group | Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731 | 1 Participants |
| Placebo HD Group | Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731 | 2 Participants |
Secondary
Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366
Subjects experiencing an LRTI associated with RSV infection were reported as AE of specific interest. To identify RSV-LRTI for the purpose of AE of specific interest, the diagnosis was based on the investigators' clinical judgment taking into account the clinical history, the examination, relevant medical investigations and locally-available diagnostic test for RSV.
Time frame: From Dose 1 administration (Day 1) up to Day 366
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV LD Group | Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366 | 0 Participants |
| RSV MD Group | Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366 | 1 Participants |
| RSV HD Group | Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366 | 0 Participants |
| Placebo LD Group | Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366 | 3 Participants |
| Placebo MD Group | Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366 | 0 Participants |
| Placebo HD Group | Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366 | 0 Participants |
Secondary
Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366
RSV-RTI refers to subject having runny nose OR blocked nose OR cough AND confirmed RSV infection \[RSV infection confirmed on nasal swab positive for RSV A or B by quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) performed at sponsor level\]. RSV-LRTI refers to subject with history of cough OR difficulty breathing \[based on history reported by parents/legally acceptable representatives (LARs) and includes difficulty breathing (e.g. showing signs of wheezing or stridor, tachypnoea, flaring of nostrils, chest in-drawing, apnoea) associated with nasal obstruction\] AND Blood Oxygen Saturation (SpO2) lower than (\<) 95 percent (%), OR respiratory rate (RR) increase \[defined as ≥ 40/minute (12 months of age or above)\] AND confirmed RSV infection. RSV-severe LRTI are cases meeting the case definition of RSV-LRTI AND SpO2 \< 93%, OR lower chest wall in-drawing.
Time frame: From Dose 1 administration (Day 1) up to Day 366
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV LD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-LRTI | 0 Participants |
| RSV LD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-RTI | 1 Participants |
| RSV LD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-severe LRTI | 0 Participants |
| RSV MD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-severe LRTI | 0 Participants |
| RSV MD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-LRTI | 0 Participants |
| RSV MD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-RTI | 3 Participants |
| RSV HD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-RTI | 1 Participants |
| RSV HD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-LRTI | 0 Participants |
| RSV HD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-severe LRTI | 0 Participants |
| Placebo LD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-RTI | 4 Participants |
| Placebo LD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-severe LRTI | 1 Participants |
| Placebo LD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-LRTI | 1 Participants |
| Placebo MD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-LRTI | 0 Participants |
| Placebo MD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-RTI | 3 Participants |
| Placebo MD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-severe LRTI | 0 Participants |
| Placebo HD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-LRTI | 0 Participants |
| Placebo HD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-RTI | 3 Participants |
| Placebo HD Group | Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 | RSV-severe LRTI | 0 Participants |
Secondary
Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731
Subjects experiencing an LRTI associated with RSV infection were reported as AE of specific interest. To identify RSV-LRTI for the purpose of AE of specific interest, the diagnosis was based on the investigators' clinical judgment taking into account the clinical history, the examination, relevant medical investigations and locally-available diagnostic test for RSV.
Time frame: From Dose 1 administration (Day 1) up to study conclusion at Day 731
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV LD Group | Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | 0 Participants |
| RSV MD Group | Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | 1 Participants |
| RSV HD Group | Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | 0 Participants |
| Placebo LD Group | Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | 3 Participants |
| Placebo MD Group | Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | 0 Participants |
| Placebo HD Group | Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | 0 Participants |
Secondary
Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731
RSV-RTI refers to subject having runny nose OR blocked nose OR cough AND confirmed RSV infection (RSV infection confirmed on nasal swab positive for RSV A or B by qRT-PCR performed at sponsor level). RSV-LRTI refers to subject with history of cough OR difficulty breathing \[based on history reported by parents/LARs and includes difficulty breathing (e.g. showing signs of wheezing or stridor, tachypnoea, flaring of nostrils, chest in-drawing, apnoea) associated with nasal obstruction\] AND Sp02 \< 95% OR respiratory rate (RR) increase \[defined as ≥ 40/minute (12 months of age or above)\] AND confirmed RSV infection. RSV-severe LRTI are cases meeting the case definition of RSV-LRTI AND SpO2 \< 93%, OR lower chest wall in-drawing.
Time frame: From Dose 1 administration (Day 1) up to study conclusion at Day 731
Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV LD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-LRTI | 0 Participants |
| RSV LD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-RTI | 2 Participants |
| RSV LD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-severe LRTI | 0 Participants |
| RSV MD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-LRTI | 0 Participants |
| RSV MD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-RTI | 6 Participants |
| RSV MD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-severe LRTI | 0 Participants |
| RSV HD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-LRTI | 0 Participants |
| RSV HD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-RTI | 2 Participants |
| RSV HD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-severe LRTI | 0 Participants |
| Placebo LD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-severe LRTI | 1 Participants |
| Placebo LD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-RTI | 5 Participants |
| Placebo LD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-LRTI | 1 Participants |
| Placebo MD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-RTI | 4 Participants |
| Placebo MD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-LRTI | 0 Participants |
| Placebo MD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-severe LRTI | 0 Participants |
| Placebo HD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-LRTI | 0 Participants |
| Placebo HD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-RTI | 4 Participants |
| Placebo HD Group | Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 | RSV-severe LRTI | 0 Participants |
Secondary
Palivizumab-competing Antibody Concentrations
Humoral response to the investigational RSV vaccine was measured as Palivizumab-competing antibody concentrations and expressed as geometric mean concentrations (GMCs) in microgram/milliliter (µg/mL).
Time frame: At Pre-vaccination (Screening), Day 31 and Day 61
Population: This analysis was performed on the Per-protocol set (PPS), which included all vaccinated subjects, meeting all protocol requirements and with available immunogenicity results for the specified assay and time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV LD Group | Palivizumab-competing Antibody Concentrations | Day 31 | 7.9 µg/mL |
| RSV LD Group | Palivizumab-competing Antibody Concentrations | Screening | 5.2 µg/mL |
| RSV LD Group | Palivizumab-competing Antibody Concentrations | Day 61 | 6.3 µg/mL |
| RSV MD Group | Palivizumab-competing Antibody Concentrations | Day 31 | 11.1 µg/mL |
| RSV MD Group | Palivizumab-competing Antibody Concentrations | Screening | 4.8 µg/mL |
| RSV MD Group | Palivizumab-competing Antibody Concentrations | Day 61 | 15.2 µg/mL |
| RSV HD Group | Palivizumab-competing Antibody Concentrations | Day 31 | 17.5 µg/mL |
| RSV HD Group | Palivizumab-competing Antibody Concentrations | Screening | 6.6 µg/mL |
| RSV HD Group | Palivizumab-competing Antibody Concentrations | Day 61 | 14 µg/mL |
| Placebo LD Group | Palivizumab-competing Antibody Concentrations | Day 31 | 8 µg/mL |
| Placebo LD Group | Palivizumab-competing Antibody Concentrations | Screening | 6.2 µg/mL |
| Placebo LD Group | Palivizumab-competing Antibody Concentrations | Day 61 | 6.1 µg/mL |
| Placebo MD Group | Palivizumab-competing Antibody Concentrations | Day 31 | 12.5 µg/mL |
| Placebo MD Group | Palivizumab-competing Antibody Concentrations | Screening | 4.8 µg/mL |
| Placebo MD Group | Palivizumab-competing Antibody Concentrations | Day 61 | 7 µg/mL |
| Placebo HD Group | Palivizumab-competing Antibody Concentrations | Screening | 7.2 µg/mL |
| Placebo HD Group | Palivizumab-competing Antibody Concentrations | Day 61 | 6.6 µg/mL |
| Placebo HD Group | Palivizumab-competing Antibody Concentrations | Day 31 | 6.8 µg/mL |