Respiratory Syncytial Virus Infections
Conditions
Keywords
Respiratory syncytial virus, Immunogenicity, Safety, Increased risk of respiratory syncytial virus lower respiratory tract disease, Adults aged 50-59 years of age, Older adults 60 years of age and above
Brief summary
The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD), versus adults \>=60 YOA
Interventions
BIOLOGICALRSVPreF3 OA investigational vaccine
One dose administered intramuscularly at Day 1.
DRUGPlacebo
One dose administered intramuscularly at Day 1.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Observer-blind for Cohort 1 (Day1-Day 31) and single-blind afterwards and open-label for Cohort 2
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol * Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure. 1\. Specific inclusion criteria for all participants in Cohort 1 (Adults HA-RSV Group, Adults HA-Placebo Group, Adults AIR-RSV Group & Adults AIR-Placebo Group) * A male or female participant 50-59 YOA at the time of the study intervention administration. * Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as 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 until study end for this study, and * has a negative pregnancy test on the day of study intervention administration. Specific inclusion criteria for participants in the Adults-HA Sub-cohort * Healthy participants as established by medical history and clinical examination before entering into the study. * Participants with chronic stable medical conditions with or without specific treatment, such as hypertension, hypercholesterolemia, or hypothyroidism, and who are not at increased risk for RSV-LRTD , are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months). Specific inclusion criteria for participants in the Adults-AIR Sub cohort Participants should be diagnosed with at least 1 of the following medical conditions and have a stable condition (no changes in the treatment or disease severity in the past 3 months): * Chronic pulmonary disease resulting in activity restricting symptoms or use of long-term medication * Chronic cardiovascular disease * Diabetes mellitus: types 1 and 2 * Other diseases at increased risk for RSV-LRTD disease * Chronic kidney disease * Chronic liver disease 2. Specific inclusion criteria for Cohort 2 (OA-RSV 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 by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months). * 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 or immunosuppressive/cytotoxic therapy, 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. * Hypersensitivity to latex. * 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. 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. * Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. 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 4, Month 12). * 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 and subunit influenza vaccines or COVID-19 vaccines (fully licensed or with EUA) which can be administered up to 14 days before or from 14 days after the study intervention administration. Note: In case an emergency mass vaccination for an unforeseen public health threat is recommended and/or organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly. * Previous vaccination with an 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 the study. * Up to 3 months prior to the study intervention administration: * For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical 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., 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 * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group | At 1 month after the RSVPreF3 OA vaccine administration (Day 31) | Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated subjects. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan. |
| RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group | At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1) | The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to 4 (\>=4). |
| RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group | At 1 month after the RSVPreF3 OA vaccine administration (Day 31) | Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan. |
| RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group | At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1) | The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \>=4. |
| RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group | At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) | Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan. |
| RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group | At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1) | The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \>=4. |
| RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group | At 1 month after the RSVPreF3 OA vaccine administration (Day 31) | Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan. |
| RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group | At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1) | The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \>=4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention | At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31) | Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups. |
| RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention | At 6 months and at 12 months after study intervention administration | Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups. |
| RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention | At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31) | Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups. |
| RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention | At 6 months and at 12 months after study intervention administration | Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups. |
| Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1) | Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters. |
| Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention | At 6 months and at 12 months after study intervention administration | Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention | At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31) | Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations. |
| Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 | At 6 months and at 12 months after study intervention administration | Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations. |
| Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention | At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31) | Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1) | Assessed solicited systemic events were arthralgia, fatigue, headache, myalgia and fever \[temperature equal to or above (\>=) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention. |
| Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs) | During the 30-day follow up period after vaccination (vaccine or placebo administered on Day 1) | Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. |
| Percentage of Participants Reporting Any Serious Adverse Events (SAEs) Within 6 Months of Vaccination | From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1) | 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, or results in an abnormal pregnancy outcome. |
| Percentage of Participants Reporting Any Onset Potential Immune Mediated Diseases (pIMDs) Within 6 Months of Vaccination | From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1) | pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. |
| Percentage of Participants Reporting SAEs Related to Study Intervention Administration Within 12 Months of Vaccination | From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1) | 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, or results in an abnormal pregnancy outcome. |
| Percentage of Participants Reporting pIMDs Related to Study Intervention Administration Within 12 Months of Vaccination | From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1) | pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. |
| Percentage of Participants Reporting Any Fatal SAEs | From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1) | 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, or results in an abnormal pregnancy outcome. |
Participant flow
Recruitment details
Out of 1544 participants enrolled in this study, 1534 participants received at least one study intervention, from which 1 participant in OA-RSV group received placebo instead of RSVPreF3 OA vaccine and was excluded from the group. Therefore, the Exposed set included 1533 participants.
Participants by arm
| Arm | Count |
|---|---|
| Adults HA-RSV Group Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end. | 383 |
| Adults HA-Placebo Group Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end. | 192 |
| Adults AIR-RSV Group Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end. | 386 |
| Adults AIR-Placebo Group Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end. | 191 |
| OA-RSV Group Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end. | 381 |
| Total | 1,533 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse event requiring expedited reporting | 0 | 0 | 4 | 1 | 0 |
| Overall Study | Consent withdrawal, not due to a (S)AE | 4 | 6 | 4 | 2 | 7 |
| Overall Study | Lost to Follow-up | 13 | 1 | 7 | 3 | 4 |
| Overall Study | Migrated / moved from the study area | 1 | 1 | 0 | 3 | 1 |
| Overall Study | Other | 2 | 0 | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | Adults HA-RSV Group | Adults HA-Placebo Group | Adults AIR-RSV Group | Adults AIR-Placebo Group | OA-RSV Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 54.8 YEARS STANDARD_DEVIATION 2.8 | 54.7 YEARS STANDARD_DEVIATION 2.8 | 55.3 YEARS STANDARD_DEVIATION 2.8 | 55.6 YEARS STANDARD_DEVIATION 2.8 | 64.1 YEARS STANDARD_DEVIATION 2.9 | 58.6 YEARS STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 48 Participants | 23 Participants | 63 Participants | 35 Participants | 50 Participants | 219 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 335 Participants | 168 Participants | 323 Participants | 156 Participants | 330 Participants | 1312 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 221 Participants | 119 Participants | 186 Participants | 85 Participants | 188 Participants | 799 Participants |
| Sex: Female, Male Male | 162 Participants | 73 Participants | 200 Participants | 106 Participants | 193 Participants | 734 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 383 | 0 / 192 | 1 / 386 | 1 / 191 | 0 / 381 |
| other Total, other adverse events | 325 / 383 | 76 / 192 | 318 / 386 | 74 / 191 | 279 / 381 |
| serious Total, serious adverse events | 3 / 383 | 4 / 192 | 15 / 386 | 4 / 191 | 9 / 381 |
Outcome results
Primary
RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated subjects. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
Population: Analysis was performed on the per protocol set (PPS) for humoral analysis 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 the administered intervention.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Adults HA-RSV Group | RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group | 7906.0 Titer |
| OA-RSV Group | RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group | 7518.9 Titer |
Comparison: To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.95% CI: [0.83, 1.09]
Primary
RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
Population: Analysis was performed on the per protocol set (PPS) for humoral analysis 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 the administered intervention.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Adults HA-RSV Group | RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group | 8925.1 Titer |
| OA-RSV Group | RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group | 7460.7 Titer |
Comparison: To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.95% CI: [0.73, 0.96]
Primary
RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to 4 (\>=4).
Time frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
Population: Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-A at 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 the administered intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults HA-RSV Group | RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group | 82.8 Percentage of participants |
| OA-RSV Group | RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group | 80.2 Percentage of participants |
Comparison: To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.95% CI: [-8.54, 3.28]
Primary
RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \>=4.
Time frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
Population: Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-A at 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 the administered intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults HA-RSV Group | RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group | 86.8 Percentage of participants |
| OA-RSV Group | RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group | 80.2 Percentage of participants |
Comparison: To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.95% CI: [-12.26, -1.12]
Primary
RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
Population: Analysis was performed on PPS for humoral analysis 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 the administered intervention.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Adults HA-RSV Group | RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group | 9024.8 Titer |
| OA-RSV Group | RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group | 8070.3 Titer |
Comparison: To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.95% CI: [0.79, 1.02]
Primary
RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
Population: Analysis was performed on PPS for humoral analysis 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 the administered intervention.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Adults HA-RSV Group | RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group | 10048.6 Titer |
| OA-RSV Group | RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group | 8073.4 Titer |
Comparison: To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.95% CI: [0.71, 0.91]
Primary
RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \>=4.
Time frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
Population: Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-B at 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 the administered intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults HA-RSV Group | RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group | 78.2 Percentage of participants |
| OA-RSV Group | RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group | 74.3 Percentage of participants |
Comparison: To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.95% CI: [-10.39, 2.53]
Primary
RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \>=4.
Time frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
Population: Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-B at 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 the administered intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults HA-RSV Group | RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group | 81.6 Percentage of participants |
| OA-RSV Group | RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group | 74.3 Percentage of participants |
Comparison: To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.95% CI: [-13.52, -1.09]
Secondary
Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention
Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At 6 months and at 12 months after study intervention administration
Population: Analysis was performed on CMI sub-cohort of the PPS, which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD4+ T cells, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only the participants with data available at the time of the analysis were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Adults HA-RSV Group | Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention | Month 6 | 825.6 CD4+ T cells/million cells | Standard Deviation 0.3 |
| Adults HA-RSV Group | Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention | Month 12 | 492.0 CD4+ T cells/million cells | Standard Deviation 0.6 |
| OA-RSV Group | Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention | Month 6 | 140.5 CD4+ T cells/million cells | Standard Deviation 0.8 |
| OA-RSV Group | Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention | Month 12 | 175.8 CD4+ T cells/million cells | Standard Deviation 0.5 |
| Adults AIR-RSV Group | Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention | Month 6 | 662.9 CD4+ T cells/million cells | Standard Deviation 0.3 |
| Adults AIR-RSV Group | Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention | Month 12 | 335.5 CD4+ T cells/million cells | Standard Deviation 0.7 |
| Adults AIR-Placebo Group | Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention | Month 12 | 59.4 CD4+ T cells/million cells | Standard Deviation 1 |
| Adults AIR-Placebo Group | Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention | Month 6 | 39.2 CD4+ T cells/million cells | Standard Deviation 1 |
| OA-RSV Group | Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention | Month 6 | 763.5 CD4+ T cells/million cells | Standard Deviation 0.5 |
| OA-RSV Group | Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention | Month 12 | 414.1 CD4+ T cells/million cells | Standard Deviation 0.7 |
Secondary
Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12
Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At 6 months and at 12 months after study intervention administration
Population: Analysis was performed on CMI sub-cohort of the PPS, which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD8+ T cells, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only the participants with data available at the time of the analysis were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Adults HA-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 | Month 6 | 23.1 CD8+ T cells/million cells | Standard Deviation 1 |
| Adults HA-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 | Month 12 | 15.2 CD8+ T cells/million cells | Standard Deviation 1 |
| OA-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 | Month 6 | 12.2 CD8+ T cells/million cells | Standard Deviation 1.1 |
| OA-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 | Month 12 | 23.0 CD8+ T cells/million cells | Standard Deviation 0.9 |
| Adults AIR-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 | Month 6 | 27.6 CD8+ T cells/million cells | Standard Deviation 1 |
| Adults AIR-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 | Month 12 | 16.2 CD8+ T cells/million cells | Standard Deviation 1 |
| Adults AIR-Placebo Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 | Month 12 | 6.6 CD8+ T cells/million cells | Standard Deviation 1.1 |
| Adults AIR-Placebo Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 | Month 6 | 14.0 CD8+ T cells/million cells | Standard Deviation 1 |
| OA-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 | Month 6 | 14.8 CD8+ T cells/million cells | Standard Deviation 1.1 |
| OA-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 | Month 12 | 14.9 CD8+ T cells/million cells | Standard Deviation 1 |
Secondary
Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention
Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Population: Analysis was performed on CMI sub-cohort of the PPS, which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD8+ T cells, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only the participants with data available at the time of the analysis were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Adults HA-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention | Day 1 | 10.1 CD8+ T cells/million cells | Standard Deviation 1.1 |
| Adults HA-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention | Day 31 | 15.2 CD8+ T cells/million cells | Standard Deviation 1.1 |
| OA-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention | Day 1 | 6.0 CD8+ T cells/million cells | Standard Deviation 0.9 |
| OA-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention | Day 31 | 11.9 CD8+ T cells/million cells | Standard Deviation 1.1 |
| Adults AIR-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention | Day 1 | 15.5 CD8+ T cells/million cells | Standard Deviation 1 |
| Adults AIR-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention | Day 31 | 18.1 CD8+ T cells/million cells | Standard Deviation 1.1 |
| Adults AIR-Placebo Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention | Day 31 | 4.8 CD8+ T cells/million cells | Standard Deviation 1.1 |
| Adults AIR-Placebo Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention | Day 1 | 10.8 CD8+ T cells/million cells | Standard Deviation 1.1 |
| OA-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention | Day 1 | 12.0 CD8+ T cells/million cells | Standard Deviation 1 |
| OA-RSV Group | Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention | Day 31 | 12.0 CD8+ T cells/million cells | Standard Deviation 1.2 |
Secondary
Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention
Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Population: Analysis was performed on Cell-Mediated immune (CMI) sub-cohort of the PPS,which included all eligible participants who received the study intervention as per protocol,had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD4+T cells, complied with blood draw intervals,without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.Only the participants with data available at the time of the analysis were reported
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Adults HA-RSV Group | Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention | Day 1 | 102.7 CD4+ T cells/million cells | Standard Deviation 0.9 |
| Adults HA-RSV Group | Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention | Day 31 | 1282.5 CD4+ T cells/million cells | Standard Deviation 0.4 |
| OA-RSV Group | Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention | Day 1 | 125.6 CD4+ T cells/million cells | Standard Deviation 0.9 |
| OA-RSV Group | Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention | Day 31 | 167.7 CD4+ T cells/million cells | Standard Deviation 0.8 |
| Adults AIR-RSV Group | Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention | Day 1 | 161.5 CD4+ T cells/million cells | Standard Deviation 0.6 |
| Adults AIR-RSV Group | Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention | Day 31 | 1043.6 CD4+ T cells/million cells | Standard Deviation 0.6 |
| Adults AIR-Placebo Group | Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention | Day 31 | 131.9 CD4+ T cells/million cells | Standard Deviation 0.8 |
| Adults AIR-Placebo Group | Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention | Day 1 | 114.7 CD4+ T cells/million cells | Standard Deviation 0.9 |
| OA-RSV Group | Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention | Day 1 | 111.3 CD4+ T cells/million cells | Standard Deviation 0.9 |
| OA-RSV Group | Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention | Day 31 | 1016.9 CD4+ T cells/million cells | Standard Deviation 0.8 |
Secondary
Percentage of Participants Reporting Any 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, or results in an abnormal pregnancy outcome.
Time frame: From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
Population: Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults HA-RSV Group | Percentage of Participants Reporting Any Fatal SAEs | 0 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Any Fatal SAEs | 0 Percentage of participants |
| Adults AIR-RSV Group | Percentage of Participants Reporting Any Fatal SAEs | 1.0 Percentage of participants |
| Adults AIR-Placebo Group | Percentage of Participants Reporting Any Fatal SAEs | 0.5 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Any Fatal SAEs | 0 Percentage of participants |
Secondary
Percentage of Participants Reporting Any Onset Potential Immune Mediated Diseases (pIMDs) Within 6 Months of Vaccination
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time frame: From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)
Population: Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults HA-RSV Group | Percentage of Participants Reporting Any Onset Potential Immune Mediated Diseases (pIMDs) Within 6 Months of Vaccination | 0 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Any Onset Potential Immune Mediated Diseases (pIMDs) Within 6 Months of Vaccination | 0 Percentage of participants |
| Adults AIR-RSV Group | Percentage of Participants Reporting Any Onset Potential Immune Mediated Diseases (pIMDs) Within 6 Months of Vaccination | 1.0 Percentage of participants |
| Adults AIR-Placebo Group | Percentage of Participants Reporting Any Onset Potential Immune Mediated Diseases (pIMDs) Within 6 Months of Vaccination | 0.5 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Any Onset Potential Immune Mediated Diseases (pIMDs) Within 6 Months of Vaccination | 0.8 Percentage of participants |
Secondary
Percentage of Participants Reporting Any Serious Adverse Events (SAEs) Within 6 Months of Vaccination
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, or results in an abnormal pregnancy outcome.
Time frame: From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)
Population: Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults HA-RSV Group | Percentage of Participants Reporting Any Serious Adverse Events (SAEs) Within 6 Months of Vaccination | 0.8 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Any Serious Adverse Events (SAEs) Within 6 Months of Vaccination | 2.1 Percentage of participants |
| Adults AIR-RSV Group | Percentage of Participants Reporting Any Serious Adverse Events (SAEs) Within 6 Months of Vaccination | 3.9 Percentage of participants |
| Adults AIR-Placebo Group | Percentage of Participants Reporting Any Serious Adverse Events (SAEs) Within 6 Months of Vaccination | 2.1 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Any Serious Adverse Events (SAEs) Within 6 Months of Vaccination | 2.4 Percentage of participants |
Secondary
Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs)
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Time frame: During the 30-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Population: Analysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for assessed timeframe and unsolicited events analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults HA-RSV Group | Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs) | 13.6 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs) | 13.5 Percentage of participants |
| Adults AIR-RSV Group | Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs) | 15.3 Percentage of participants |
| Adults AIR-Placebo Group | Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs) | 10.5 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs) | 16.3 Percentage of participants |
Secondary
Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling)
Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
Time frame: During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Population: Analysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for solicited administration site events analysis at the assessed timeframe.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults HA-RSV Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Erythema | 11.9 Percentage of participants |
| Adults HA-RSV Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Swelling | 9.3 Percentage of participants |
| Adults HA-RSV Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Pain | 76.7 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Pain | 10.5 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Erythema | 0.5 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Swelling | 1.0 Percentage of participants |
| Adults AIR-RSV Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Pain | 75.2 Percentage of participants |
| Adults AIR-RSV Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Erythema | 14.5 Percentage of participants |
| Adults AIR-RSV Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Swelling | 11.6 Percentage of participants |
| Adults AIR-Placebo Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Erythema | 0.5 Percentage of participants |
| Adults AIR-Placebo Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Swelling | 0.5 Percentage of participants |
| Adults AIR-Placebo Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Pain | 14.3 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Pain | 61.2 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Erythema | 12.1 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) | Swelling | 7.7 Percentage of participants |
Secondary
Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness)
Assessed solicited systemic events were arthralgia, fatigue, headache, myalgia and fever \[temperature equal to or above (\>=) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
Time frame: During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Population: Analysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for solicited systemic events analysis at the assessed timeframe.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults HA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Myalgia | 39.3 Percentage of participants |
| Adults HA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Arthralgia | 26.0 Percentage of participants |
| Adults HA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Fever | 3.7 Percentage of participants |
| Adults HA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Fatigue | 44.0 Percentage of participants |
| Adults HA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Headache | 35.8 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Myalgia | 5.8 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Headache | 16.8 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Fatigue | 17.3 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Fever | 1.0 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Arthralgia | 5.8 Percentage of participants |
| Adults AIR-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Headache | 27.7 Percentage of participants |
| Adults AIR-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Arthralgia | 20.8 Percentage of participants |
| Adults AIR-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Fatigue | 36.1 Percentage of participants |
| Adults AIR-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Myalgia | 32.5 Percentage of participants |
| Adults AIR-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Fever | 2.6 Percentage of participants |
| Adults AIR-Placebo Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Fever | 1.1 Percentage of participants |
| Adults AIR-Placebo Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Arthralgia | 10.0 Percentage of participants |
| Adults AIR-Placebo Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Myalgia | 14.2 Percentage of participants |
| Adults AIR-Placebo Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Headache | 17.4 Percentage of participants |
| Adults AIR-Placebo Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Fatigue | 19.5 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Headache | 21.1 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Myalgia | 21.4 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Arthralgia | 12.9 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Fever | 1.6 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) | Fatigue | 24.0 Percentage of participants |
Secondary
Percentage of Participants Reporting pIMDs Related to Study Intervention Administration Within 12 Months of Vaccination
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time frame: From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
Population: Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults HA-RSV Group | Percentage of Participants Reporting pIMDs Related to Study Intervention Administration Within 12 Months of Vaccination | 0 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting pIMDs Related to Study Intervention Administration Within 12 Months of Vaccination | 0 Percentage of participants |
| Adults AIR-RSV Group | Percentage of Participants Reporting pIMDs Related to Study Intervention Administration Within 12 Months of Vaccination | 0 Percentage of participants |
| Adults AIR-Placebo Group | Percentage of Participants Reporting pIMDs Related to Study Intervention Administration Within 12 Months of Vaccination | 0 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting pIMDs Related to Study Intervention Administration Within 12 Months of Vaccination | 0.3 Percentage of participants |
Secondary
Percentage of Participants Reporting SAEs Related to Study Intervention Administration Within 12 Months of Vaccination
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, or results in an abnormal pregnancy outcome.
Time frame: From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
Population: Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults HA-RSV Group | Percentage of Participants Reporting SAEs Related to Study Intervention Administration Within 12 Months of Vaccination | 0 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting SAEs Related to Study Intervention Administration Within 12 Months of Vaccination | 0 Percentage of participants |
| Adults AIR-RSV Group | Percentage of Participants Reporting SAEs Related to Study Intervention Administration Within 12 Months of Vaccination | 0 Percentage of participants |
| Adults AIR-Placebo Group | Percentage of Participants Reporting SAEs Related to Study Intervention Administration Within 12 Months of Vaccination | 0 Percentage of participants |
| OA-RSV Group | Percentage of Participants Reporting SAEs Related to Study Intervention Administration Within 12 Months of Vaccination | 0.3 Percentage of participants |
Secondary
RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
Time frame: At 6 months and at 12 months after study intervention administration
Population: Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for the assessed analysis, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only those participants with data available at the time of the analysis were reported in this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults HA-RSV Group | RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention | Month 6 | 3850.7 Titer |
| Adults HA-RSV Group | RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention | Month 12 | 3192.9 Titer |
| OA-RSV Group | RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention | Month 6 | 849.6 Titer |
| OA-RSV Group | RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention | Month 12 | 965.1 Titer |
| Adults AIR-RSV Group | RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention | Month 6 | 3980.6 Titer |
| Adults AIR-RSV Group | RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention | Month 12 | 3075.1 Titer |
| Adults AIR-Placebo Group | RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention | Month 12 | 971.8 Titer |
| Adults AIR-Placebo Group | RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention | Month 6 | 854.2 Titer |
| OA-RSV Group | RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention | Month 6 | 3846.3 Titer |
| OA-RSV Group | RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention | Month 12 | 3080.4 Titer |
Secondary
RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
Time frame: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Population: Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for the assessed analysis, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only those participants with data available at the time of the analysis were reported in this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults HA-RSV Group | RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 1 | 768.8 Titer |
| Adults HA-RSV Group | RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 31 | 7925.4 Titer |
| OA-RSV Group | RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 1 | 772.0 Titer |
| OA-RSV Group | RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 31 | 796.9 Titer |
| Adults AIR-RSV Group | RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 1 | 779.5 Titer |
| Adults AIR-RSV Group | RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 31 | 8804.1 Titer |
| Adults AIR-Placebo Group | RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 31 | 774.7 Titer |
| Adults AIR-Placebo Group | RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 1 | 729.8 Titer |
| OA-RSV Group | RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 1 | 775.7 Titer |
| OA-RSV Group | RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 31 | 7498.8 Titer |
Secondary
RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
Time frame: At 6 months and at 12 months after study intervention administration
Population: Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for the assessed analysis, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only those participants with data available at the time of the analysis were reported in this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults HA-RSV Group | RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention | Month 6 | 3880.7 Titer |
| Adults HA-RSV Group | RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention | Month 12 | 3562.8 Titer |
| OA-RSV Group | RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention | Month 6 | 1003.2 Titer |
| OA-RSV Group | RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention | Month 12 | 1218.6 Titer |
| Adults AIR-RSV Group | RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention | Month 6 | 4020.8 Titer |
| Adults AIR-RSV Group | RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention | Month 12 | 3669.9 Titer |
| Adults AIR-Placebo Group | RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention | Month 12 | 1153.5 Titer |
| Adults AIR-Placebo Group | RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention | Month 6 | 942.1 Titer |
| OA-RSV Group | RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention | Month 6 | 3710.4 Titer |
| OA-RSV Group | RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention | Month 12 | 3527.7 Titer |
Secondary
RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
Time frame: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Population: Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for the assessed analysis, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only those participants with data available at the time of the analysis were reported in this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults HA-RSV Group | RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 1 | 1091.1 Titer |
| Adults HA-RSV Group | RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 31 | 8971.9 Titer |
| OA-RSV Group | RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 1 | 1197.7 Titer |
| OA-RSV Group | RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 31 | 1145.3 Titer |
| Adults AIR-RSV Group | RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 1 | 1141.4 Titer |
| Adults AIR-RSV Group | RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 31 | 9943.0 Titer |
| Adults AIR-Placebo Group | RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 31 | 1141.8 Titer |
| Adults AIR-Placebo Group | RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 1 | 1167.2 Titer |
| OA-RSV Group | RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 1 | 1109.1 Titer |
| OA-RSV Group | RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention | Day 31 | 8169.3 Titer |