Respiratory Syncytial Virus Infections
Conditions
Keywords
Respiratory Syncytial Virus (RSV), Immunogenicity, Safety, Non-inferiority, Humoral immune response, At increased risk (AIR), Older Adults
Brief summary
The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for RSV disease, compared to older adults (OA) 60 YOA and above.
Interventions
BIOLOGICALRSVPreF3 OA investigational vaccine
1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants and/or participant's parent(s)/ Legally acceptable representative (LAR) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attend study site visits, ability to access and utilize a phone or other electronic communications). * Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) (participant must be able to understand the informed consent) prior to performance of any study-specific procedure. Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than the legal age prior to performance of any study-specific procedure. Specific inclusion criteria for all participants in Cohort 1 and Cohort 3 (RSV-A-AIR Group) • A male or female participant 18-49 YOA at the time of the study intervention administration. * Participants should be diagnosed with at least 1 of the following medical conditions if considered medically stable by the investigator: * Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of long term medication: o Chronic obstructive pulmonary disease (COPD) o Asthma o Cystic fibrosis o Other chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis o Chronic heart failure: o Pre-existing Coronary Artery Disease (CAD) (CAD not otherwise specified) * Cardiac arrhythmia * Diabetes mellitus: types 1 or 2 with active treatment for the past 6 months * Other diseases at increased risk for RSV disease: * Chronic kidney disease * Chronic moderate to severe liver disease * Neurologic or neuromuscular conditions * Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as premenarche, hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause. * Female participants of childbearing potential may be enrolled in the study, if the participant: * has practiced adequate contraception from 1 month prior to study intervention administration, and * has a negative pregnancy test on the day of study prior to intervention administration, and * has agreed to continue adequate contraception for at least 1 month after completion of the study intervention administration. Specific inclusion criteria for all participants in Cohort 2 (RSV-OA Group): • A male or female participant \>=60 YOA at the time of the study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered medically stable by the investigator. • Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
Exclusion criteria
Medical conditions * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required). * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. * Unstable chronic illness. * Any history of dementia or any medical condition that moderately or severely impairs cognition. * Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g., completion of the diary cards, attend study site visits). Study participants may decide to assign a caregiver to help them complete the study procedures. * Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease). * Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior/Concomitant therapy * Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 3, Month 6). * Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration. * Previous vaccination with any RSV vaccine, including investigational RSV vaccines. * Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the End-of-study (EOS). * Up to 3 months prior to the study intervention administration: * For corticosteroids, this will mean prednisone \>=20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed * Administration of immunoglobulins and/or any blood products or plasma derivatives * Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., Tumor Necrosis Factor (TNF)-inhibitors), monoclonal antibodies, antitumoral medication. Prior/Concurrent clinical study experience • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or invasive medical device). Other exclusions: Other exclusions for all participants: * History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. * Bedridden participants. * Planned move during the study period that will prohibit participating in the study until study end. * Participation of any study personnel or their immediate dependents, family, or household members. Other exclusions for Cohort 1 and Cohort 3: * Pregnant or lactating female participant. * Female planning to become pregnant or planning to discontinue contraceptive precautions within 1 month after study intervention administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs) | At Day 31 | RSV-A neutralizing titers are given as group GMTs and are expressed as Estimated dilution 60 (ED60) |
| Part A: Percentage of Participants With Seroresponse Rate (SRR) in RSV-A Neutralizing Titers | Day 31 compared with baseline (Day 1) | SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration) ≥4. RSV-A neutralizing titers are expressed as ED60. |
| Part A: RSV-B Neutralizing Titers Expressed as Group GMTs | At Day 31 | RSV-B neutralizing titers are given as group GMTs and are expressed as ED60. |
| Part A: Percentage of Participants With SRR in RSV-B Neutralizing Titers | Day 31 compared with baseline (Day 1) | SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1-month post-study intervention administration over pre-study intervention administration) ≥ 4. RSV-B neutralizing titers are expressed as ED60. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A and B: Number of Participants Reporting Any Adverse Events of Special Interest (AESIs) | Throughout the study period (Day 1 to Month 6) | AESIs assessed were potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF). pIMDs were a subset of AESIs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. AEs of AF were considered as AESI. |
| Part A and B: Number of Participants Reporting Any Solicited Administration Site Events | Day 1 (post dose) to Day 4 | Assessed solicited administration site events were pain, redness (erythema) and swelling at administration site. Any = occurrence of the symptom regardless of intensity grade. |
| Part A: RSV-B Neutralizing Titers Expressed as GMTs | At Day 1 (pre-dose), at Month 1 and Month 6 | RSV-B neutralizing titers are given as GMTs and are expressed as ED60. |
| Part A: RSV-A Neutralizing Titers Expressed as GMTs | At Day 1 (pre-dose), at Month 1 and Month 6 | RSV-A neutralizing titers are given as GMTs and are expressed as ED60. |
| Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Day 1 (post dose) to Day 4 | Assessed solicited systemic events were fever (pyrexia), headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness). Fever was defined as temperature ≥38.0 degrees Celsius (°C), regardless of the location of measurement. The route for measuring temperature could be oral or axillary. Any = occurrence of the symptom regardless of intensity grade. |
| Part A and B: Number of Participants Reporting Unsolicited Adverse Events (AEs) | Day 1 (post dose) to Day 30 | An unsolicited AE wass an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs included both serious and non-serious AEs. |
| Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs | Throughout the study period (Day 1 to Month 6) | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes. Any SAE = occurrence of the SAE regardless of the intensity grade or relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination. |
Countries
Australia, Canada, Germany, Japan, South Africa, United States
Participant flow
Pre-assignment details
1459 participants were enrolled, out of which 1458 were included in the Exposed set and started the study.
Participants by arm
| Arm | Count |
|---|---|
| Part A: RSV-A-AIR Group Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol. | 426 |
| Part A: RSV-OA Group Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. | 429 |
| Part B: RSV-A-AIR Group Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol. | 603 |
| Total | 1,458 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 5 | 13 |
| Overall Study | Other | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 1 |
Baseline characteristics
| Characteristic | Part A: RSV-A-AIR Group | Part A: RSV-OA Group | Part B: RSV-A-AIR Group | Total |
|---|---|---|---|---|
| Age, Continuous | 38.9 YEARS STANDARD_DEVIATION 7.8 | 68.6 YEARS STANDARD_DEVIATION 5.7 | 38.1 YEARS STANDARD_DEVIATION 8.7 | 47.3 YEARS STANDARD_DEVIATION 15.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 8 Participants | 0 Participants | 11 Participants | 19 Participants |
| Race/Ethnicity, Customized Asian | 60 Participants | 50 Participants | 64 Participants | 174 Participants |
| Race/Ethnicity, Customized Balck or African American | 77 Participants | 54 Participants | 181 Participants | 312 Participants |
| Race/Ethnicity, Customized Multiple Race Categories | 19 Participants | 22 Participants | 59 Participants | 100 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 11 Participants | 11 Participants |
| Race/Ethnicity, Customized Not reported | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Unknown | 4 Participants | 0 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 255 Participants | 302 Participants | 274 Participants | 831 Participants |
| Sex: Female, Male Female | 247 Participants | 220 Participants | 347 Participants | 814 Participants |
| Sex: Female, Male Male | 179 Participants | 209 Participants | 256 Participants | 644 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 426 | 0 / 429 | 0 / 603 |
| other Total, other adverse events | 386 / 426 | 310 / 429 | 483 / 603 |
| serious Total, serious adverse events | 4 / 426 | 13 / 429 | 10 / 603 |
Outcome results
Primary
Part A: Percentage of Participants With Seroresponse Rate (SRR) in RSV-A Neutralizing Titers
SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration) ≥4. RSV-A neutralizing titers are expressed as ED60.
Time frame: Day 31 compared with baseline (Day 1)
Population: Analysis was performed on the PPS which included all eligible participants who received the study intervention as per protocol, had RSV-A immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on age and medical condition including participants with data available at specified timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: RSV-A-AIR Group | Part A: Percentage of Participants With Seroresponse Rate (SRR) in RSV-A Neutralizing Titers | 87.0 Percentage of participants |
| Part A: RSV-OA Group | Part A: Percentage of Participants With Seroresponse Rate (SRR) in RSV-A Neutralizing Titers | 77.7 Percentage of participants |
Comparison: To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.95% CI: [-14.55, -4.1]
Primary
Part A: Percentage of Participants With SRR in RSV-B Neutralizing Titers
SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1-month post-study intervention administration over pre-study intervention administration) ≥ 4. RSV-B neutralizing titers are expressed as ED60.
Time frame: Day 31 compared with baseline (Day 1)
Population: Analysis was performed on the PPS which included all eligible participants who received the study intervention as per protocol, had RSV-B immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on age and medical condition including participants with data available at specified timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: RSV-A-AIR Group | Part A: Percentage of Participants With SRR in RSV-B Neutralizing Titers | 87.2 Percentage of participants |
| Part A: RSV-OA Group | Part A: Percentage of Participants With SRR in RSV-B Neutralizing Titers | 77.2 Percentage of participants |
Comparison: To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.95% CI: [-15.26, -4.8]
Primary
Part A: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
RSV-A neutralizing titers are given as group GMTs and are expressed as Estimated dilution 60 (ED60)
Time frame: At Day 31
Population: Analysis was performed on the per protocol set (PPS) which included all eligible participants who received the study intervention as per protocol, had RSV-A immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on age and medical condition including participants with data available at specified timepoint.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A: RSV-A-AIR Group | Part A: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs) | 11910.1 Titer |
| Part A: RSV-OA Group | Part A: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs) | 8593.6 Titer |
Comparison: To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.95% CI: [0.64, 0.81]
Primary
Part A: RSV-B Neutralizing Titers Expressed as Group GMTs
RSV-B neutralizing titers are given as group GMTs and are expressed as ED60.
Time frame: At Day 31
Population: Analysis was performed on the PPS which included all eligible participants who received the study intervention as per protocol, had RSV-B immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on age and medical condition including participants with data available at specified timepoint.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A: RSV-A-AIR Group | Part A: RSV-B Neutralizing Titers Expressed as Group GMTs | 12496.4 Titer |
| Part A: RSV-OA Group | Part A: RSV-B Neutralizing Titers Expressed as Group GMTs | 9089.7 Titer |
Comparison: To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.95% CI: [0.65, 0.82]
Secondary
Part A and B: Number of Participants Reporting Any Adverse Events of Special Interest (AESIs)
AESIs assessed were potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF). pIMDs were a subset of AESIs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. AEs of AF were considered as AESI.
Time frame: Throughout the study period (Day 1 to Month 6)
Population: Exposed Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Adverse Events of Special Interest (AESIs) | 1 Participants |
| Part A: RSV-OA Group | Part A and B: Number of Participants Reporting Any Adverse Events of Special Interest (AESIs) | 2 Participants |
| Part B: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Adverse Events of Special Interest (AESIs) | 2 Participants |
Secondary
Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes. Any SAE = occurrence of the SAE regardless of the intensity grade or relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.
Time frame: Throughout the study period (Day 1 to Month 6)
Population: Exposed Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs | Related SAEs | 0 Participants |
| Part A: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs | Any SAEs | 4 Participants |
| Part A: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs | Fatal SAEs | 0 Participants |
| Part A: RSV-OA Group | Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs | Related SAEs | 0 Participants |
| Part A: RSV-OA Group | Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs | Any SAEs | 13 Participants |
| Part A: RSV-OA Group | Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs | Fatal SAEs | 0 Participants |
| Part B: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs | Any SAEs | 10 Participants |
| Part B: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs | Fatal SAEs | 0 Participants |
| Part B: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs | Related SAEs | 0 Participants |
Secondary
Part A and B: Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events were pain, redness (erythema) and swelling at administration site. Any = occurrence of the symptom regardless of intensity grade.
Time frame: Day 1 (post dose) to Day 4
Population: Analysis was performed on the Exposed Set, which included all participants who received the study intervention. Analysis per group is based on age and medical condition. Only those participants with solicited administration site events were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Administration Site Events | Swelling | 25 Participants |
| Part A: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Administration Site Events | Redness | 36 Participants |
| Part A: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Administration Site Events | Pain | 358 Participants |
| Part A: RSV-OA Group | Part A and B: Number of Participants Reporting Any Solicited Administration Site Events | Redness | 23 Participants |
| Part A: RSV-OA Group | Part A and B: Number of Participants Reporting Any Solicited Administration Site Events | Pain | 246 Participants |
| Part A: RSV-OA Group | Part A and B: Number of Participants Reporting Any Solicited Administration Site Events | Swelling | 19 Participants |
| Part B: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Administration Site Events | Pain | 422 Participants |
| Part B: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Administration Site Events | Swelling | 47 Participants |
| Part B: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Administration Site Events | Redness | 52 Participants |
Secondary
Part A and B: Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events were fever (pyrexia), headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness). Fever was defined as temperature ≥38.0 degrees Celsius (°C), regardless of the location of measurement. The route for measuring temperature could be oral or axillary. Any = occurrence of the symptom regardless of intensity grade.
Time frame: Day 1 (post dose) to Day 4
Population: Exposed Set. Only those participants with solicited systemic events were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Fatigue | 275 Participants |
| Part A: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Fever | 25 Participants |
| Part A: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Myalgia | 284 Participants |
| Part A: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Headache | 198 Participants |
| Part A: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Arthralgia | 124 Participants |
| Part A: RSV-OA Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Headache | 78 Participants |
| Part A: RSV-OA Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Fatigue | 148 Participants |
| Part A: RSV-OA Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Arthralgia | 78 Participants |
| Part A: RSV-OA Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Fever | 11 Participants |
| Part A: RSV-OA Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Myalgia | 169 Participants |
| Part B: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Fatigue | 337 Participants |
| Part B: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Fever | 26 Participants |
| Part B: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Headache | 250 Participants |
| Part B: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Arthralgia | 167 Participants |
| Part B: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Any Solicited Systemic Events | Myalgia | 331 Participants |
Secondary
Part A and B: Number of Participants Reporting Unsolicited Adverse Events (AEs)
An unsolicited AE wass an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs included both serious and non-serious AEs.
Time frame: Day 1 (post dose) to Day 30
Population: Exposed Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Unsolicited Adverse Events (AEs) | 72 Participants |
| Part A: RSV-OA Group | Part A and B: Number of Participants Reporting Unsolicited Adverse Events (AEs) | 76 Participants |
| Part B: RSV-A-AIR Group | Part A and B: Number of Participants Reporting Unsolicited Adverse Events (AEs) | 118 Participants |
Secondary
Part A: RSV-A Neutralizing Titers Expressed as GMTs
RSV-A neutralizing titers are given as GMTs and are expressed as ED60.
Time frame: At Day 1 (pre-dose), at Month 1 and Month 6
Population: Analysis was performed on the PPS which included all eligible participants who received the study intervention as per protocol, had RSV-A immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on age and medical condition including participants with data available at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: RSV-A-AIR Group | Part A: RSV-A Neutralizing Titers Expressed as GMTs | Day 1 | 892.6 Titer |
| Part A: RSV-A-AIR Group | Part A: RSV-A Neutralizing Titers Expressed as GMTs | Month 1 | 11853.4 Titer |
| Part A: RSV-A-AIR Group | Part A: RSV-A Neutralizing Titers Expressed as GMTs | Month 6 | 4439.8 Titer |
| Part A: RSV-OA Group | Part A: RSV-A Neutralizing Titers Expressed as GMTs | Day 1 | 913.8 Titer |
| Part A: RSV-OA Group | Part A: RSV-A Neutralizing Titers Expressed as GMTs | Month 1 | 8632.4 Titer |
| Part A: RSV-OA Group | Part A: RSV-A Neutralizing Titers Expressed as GMTs | Month 6 | 3917.7 Titer |
Secondary
Part A: RSV-B Neutralizing Titers Expressed as GMTs
RSV-B neutralizing titers are given as GMTs and are expressed as ED60.
Time frame: At Day 1 (pre-dose), at Month 1 and Month 6
Population: Analysis was performed on the PPS which included all eligible participants who received the study intervention as per protocol, had RSV-B immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on age and medical condition including participants with data available at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: RSV-A-AIR Group | Part A: RSV-B Neutralizing Titers Expressed as GMTs | Day 1 | 988.1 Titer |
| Part A: RSV-A-AIR Group | Part A: RSV-B Neutralizing Titers Expressed as GMTs | Month 1 | 12337.6 Titer |
| Part A: RSV-A-AIR Group | Part A: RSV-B Neutralizing Titers Expressed as GMTs | Month 6 | 4335.6 Titer |
| Part A: RSV-OA Group | Part A: RSV-B Neutralizing Titers Expressed as GMTs | Day 1 | 1045.1 Titer |
| Part A: RSV-OA Group | Part A: RSV-B Neutralizing Titers Expressed as GMTs | Month 1 | 9178.5 Titer |
| Part A: RSV-OA Group | Part A: RSV-B Neutralizing Titers Expressed as GMTs | Month 6 | 4355.0 Titer |