Respiratory Syncytial Virus Infections
Conditions
Keywords
Respiratory syncytial virus, Vaccine, Immunogenicity, Safety
Brief summary
The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.
Interventions
BIOLOGICALRSVPreF3 OA Investigational Vaccine
0.5 mililiter dose was administered intramuscularly as 1 dose to RSV\_IC\_1 and RSV\_HA groups, and 2 doses to RSV\_IC\_2 group.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This study is an open label study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants and/or participant's parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living. * 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. * Female participants of nonchildbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and 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 agreed to continue adequate contraception until study end for this study, and has a negative pregnancy test on the day of and prior to study intervention administration. Specific inclusion criteria for renal/lung transplant patients: * A male or female, \>=18 YoA at the time of signing the Informed consent form (ICF) or Informed assent form (IAF). * Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than legal age of consent, or written informed consent obtained from the participant if the participant has achieved legal age of consent. * Participant who has received an ABO compatible allogeneic renal or lung transplant (allograft) more than 12 months (365 days) prior to the first study intervention administration. * Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection. Specific inclusion criteria for renal transplant (RTx) patients: • Participant with stable renal function, stability defined as less than 20% variability between last two results of eGFR or in the opinion of the investigator after investigator review of more than the last two results of eGFRs and based on medical history. Specific inclusion criteria for lung transplant (LTx) patients: • Participant with stable lung function, with stability defined as the stability in the FEV1 compared to post-transplant baseline FEV1 and based on medical history of the last 3 months, in the opinion of the investigator. Specific inclusion criteria for healthy participants: * A male or female, \>=50 YoA at the time of signing the ICF. * Healthy participants as established by medical history and clinical examination before entering the study. * Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration. * Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.
Exclusion criteria
Medical conditions: * History of any reaction/ hypersensitivity likely to be exacerbated by any component of the study intervention. * Acute or chronic clinically significant cardiovascular or hepatic functional abnormality as determined by physical examination or laboratory screening tests. * Recurrent/uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study if their condition will allow them to comply with the requirements of the protocol, with the help of a caregiver if needed. * Any history of dementia or any medical condition that moderately or severely impairs cognition. * Any condition which would make IM injection unsafe. * Significant underlying illness that would prevent completion of the study). * Acute disease and/or fever at the time of study intervention administration (\>=38°C /100.4°F, oral or axillary). Participants with a minor illness without fever may be enrolled at the discretion of the investigator. * Bedridden participants. Prior/Concomitant therapy: * Use of any other investigational or non-registered product (drug, vaccine, or medical device) up to 30 days before the first dose administration (Day -30 to Day 1), or their planned use during the study period (up to Visit 6). * Previous vaccination with the study antigen (RSV), including investigational RSV vaccines. * Unexpected vaccine administration during a study should not occur 30 days prior to the first dose or 30 days after the last dose. For COVID-19 and inactivated/subunit/split influenza vaccines, this window is shortened to 14 days. Prior/Concurrent clinical study experience: • Concurrently participating in another active clinical study Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RSV-A Serum Neutralizing Titers Expressed As Mean Geometric Increase (MGI) Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group | At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days) | MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-A post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3). |
| RSV-B Serum Neutralizing Titers Expressed As MGI Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group | At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days) | MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-B post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups | At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days) | Group GMT was assessed for RSV\_HA group over pooled RSV\_IC group (combined RSV\_IC\_1 and RSV\_IC\_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_HA and Pooled RSV\_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan. |
| RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days) | Group GMT of RSV\_IC\_2 over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_IC\_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan. |
| RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days) | Group GMT of RSV\_HA over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan. |
| RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days) | Group GMT of RSV\_HA over RSV\_IC\_2 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_2 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan. |
| RSV-A Serum Neutralizing Titers Expressed as Group GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) | — |
| RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups | At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days) | Group GMT was assessed for RSV\_HA group over pooled RSV\_IC group (combined RSV\_IC\_1 and RSV\_IC\_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_HA and Pooled RSV\_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan. |
| RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days) | Group GMT ratio of RSV\_IC\_2 over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_IC\_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan. |
| RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days) | Group GMT of RSV\_HA over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan. |
| RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups | At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days) | Group GMT of RSV\_HA over RSV\_IC\_2 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_2 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan. |
| RSV-B Serum Neutralizing Titers Expressed as Group GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | At Visit 5 (last dose +180-210 days) and Visit 6 (last dose + 350-380 days) | — |
| RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days), each compared to Visit 1 (Day 1) | MGI was assessed at Visit 2 (in a subset of participants) over Visit 1 and Visit 3 over Visit 1 in RSV\_HA and pooled RSV\_IC (combined RSV\_IC\_1 and RSV\_IC\_2 groups), and at Visit 4 over Visit 1 in RSV\_IC\_1, RSV\_IC\_2, RSV\_HA groups. |
| RSV-A and RSV-B Serum Neutralizing Titers Expressed as MGI | At Visit 5 (last dose +180-210 days) and Visit 6 (last dose + 350-380 days), each compared with Visit 1 (Day 1) | — |
| RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 in a subset of participants (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days) | Neutralizing titers were calculated as GMT and expressed in titers (Estimated Dilution 60 \[ED60\]). |
| Number of Participants Reporting Any AESIs Specific to Renal and Lung SOT Participants | From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group) | AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV\_IC\_1 and RSV\_IC\_2 groups. |
| CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days) | CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV\_IC\_1 and RSV\_IC\_2 groups) and healthy participants (from RSV\_HA group). |
| CMI Response in a Subset of Participants | At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) | — |
| Number Of Participants Reporting Any Solicited Administration Site Events | Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group) | Assessed solicited administration site events included pain, erythema (redness) and swelling, at the injection site. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention. |
| Number Of Participants Reporting Any Solicited Systemic Events | Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group) | Assessed solicited systemic events included fever (pyrexia), myalgia, arthralgia, headache, and fatigue. Fever is defined as body temperature greater or equal to (≥) 38 degrees Celsius (ºC). Any = occurrence of the symptom regardless of intensity grade or relation to study intervention. |
| Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration | Within 30 days (i.e., the day of vaccination and 29 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group) | An unsolicited AE is an AE that was not included in the list of solicited events. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention. |
| Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs | From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group) | A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of 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. |
| Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention | From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group) | pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination. |
| Number Of Participants With Any AEs Of Special Interest (AESIs) Specific To Renal And Lung SOT Participants | From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group) | AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV\_IC\_1 and RSV\_IC\_2 groups. |
| Number of Participants Reporting Any SAEs, SAEs Related to Study Intervention and Fatal SAEs | From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group) | A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of 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. |
| Number of Participants Reporting Any pIMDs and pIMDs Related to Study Intervention | From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group) | pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination. |
| Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days) | CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific cluster of differentiation CD4+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV\_IC\_1 and RSV\_IC\_2 groups) and healthy participants (from RSV\_HA group). |
| RSV-A and RSV-B Serum Neutralizing Titers Expressed as GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days) | Neutralizing titers were calculated as GMT and expressed in titers (ED60). |
Countries
Australia, Canada, Germany, Italy, Japan, South Korea, Spain, United States
Participant flow
Recruitment details
Participants from 48 study sites were enrolled in the study.
Pre-assignment details
All participants enrolled were randomized to the Exposed set and started the study. Analysis presented includes data up to Primary Completion. Additional results will be provided within one year of study completion.
Participants by arm
| Arm | Count |
|---|---|
| RSV_IC_1 Group Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). | 131 |
| RSV_IC_2 Group IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days). | 130 |
| RSV_HA Group Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). | 125 |
| Total | 386 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Ongoing at the time of Primary Completion Analysis | 129 | 126 | 112 |
| Overall Study | SAEs/pIMDs/AESIs specific to SOT | 0 | 3 | 1 |
| Overall Study | Unsolicited non-SAE | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | RSV_IC_2 Group | Total | RSV_HA Group | RSV_IC_1 Group |
|---|---|---|---|---|
| Age, Continuous | 61.4 YEARS STANDARD_DEVIATION 8.4 | 62.4 YEARS STANDARD_DEVIATION 8.7 | 63.8 YEARS STANDARD_DEVIATION 8.2 | 61.9 YEARS STANDARD_DEVIATION 9.3 |
| Race/Ethnicity, Customized All Other Races | 51 Participants | 123 Participants | 30 Participants | 42 Participants |
| Race/Ethnicity, Customized White | 79 Participants | 263 Participants | 95 Participants | 89 Participants |
| Sex: Female, Male Female | 50 Participants | 170 Participants | 66 Participants | 54 Participants |
| Sex: Female, Male Male | 80 Participants | 216 Participants | 59 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 131 | 2 / 130 | 0 / 125 |
| other Total, other adverse events | 106 / 131 | 120 / 130 | 111 / 125 |
| serious Total, serious adverse events | 12 / 131 | 18 / 130 | 3 / 125 |
Outcome results
Primary
RSV-A Serum Neutralizing Titers Expressed As Mean Geometric Increase (MGI) Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group
MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-A post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).
Time frame: At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)
Population: Analysis was performed on the Per protocol Set (PPS) for humoral immunogenicity, which included all participants who received the study intervention administration as per protocol, had immunogenicity results pre and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity, without prohibited concomitant medication/vaccination. Only participants with data available at the specified timepoints were included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_IC_2 Group | RSV-A Serum Neutralizing Titers Expressed As Mean Geometric Increase (MGI) Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group | 1.34 Ratio |
Primary
RSV-B Serum Neutralizing Titers Expressed As MGI Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group
MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-B post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).
Time frame: At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)
Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_IC_2 Group | RSV-B Serum Neutralizing Titers Expressed As MGI Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group | 1.26 Ratio |
Secondary
Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells
CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific cluster of differentiation CD4+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV\_IC\_1 and RSV\_IC\_2 groups) and healthy participants (from RSV\_HA group).
Time frame: At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)
Population: Analysis was performed on the PPS for cell mediated immunity (CMI), which included all participants who received the study intervention administration as per protocol, had cell mediated immunogenicity results pre and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity, without prohibited concomitant medication/vaccination. Only participants with data available for CD4+ T cells at the specified timepoints were included in analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| RSV_IC_2 Group | Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | Visit 1 | 86.8 Specific CD4+ Tcells/million CD4+ Tcells | Standard Deviation 1 |
| RSV_IC_2 Group | Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | Visit 2 | 2932.2 Specific CD4+ Tcells/million CD4+ Tcells | Standard Deviation 0.6 |
| RSV_IC_2 Group | Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | Visit 3 | 1049.0 Specific CD4+ Tcells/million CD4+ Tcells | Standard Deviation 0.8 |
| RSV_IC_2 Group | Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | Visit 4 | 910.8 Specific CD4+ Tcells/million CD4+ Tcells | Standard Deviation 0.8 |
| RSV_IC_2 Group | Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | Visit 4 | 2709.0 Specific CD4+ Tcells/million CD4+ Tcells | Standard Deviation 0.3 |
| RSV_IC_2 Group | Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | Visit 1 | 110.3 Specific CD4+ Tcells/million CD4+ Tcells | Standard Deviation 0.9 |
| RSV_IC_2 Group | Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | Visit 3 | 1718.5 Specific CD4+ Tcells/million CD4+ Tcells | Standard Deviation 0.4 |
| RSV_IC_2 Group | Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | Visit 2 | 3704.3 Specific CD4+ Tcells/million CD4+ Tcells | Standard Deviation 0.5 |
| RSV_HA Group | Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | Visit 4 | 734.4 Specific CD4+ Tcells/million CD4+ Tcells | Standard Deviation 0.3 |
| RSV_HA Group | Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | Visit 2 | 2959.8 Specific CD4+ Tcells/million CD4+ Tcells | Standard Deviation 0.3 |
| RSV_HA Group | Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | Visit 3 | 1042.4 Specific CD4+ Tcells/million CD4+ Tcells | Standard Deviation 0.3 |
| RSV_HA Group | Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells | Visit 1 | 107.8 Specific CD4+ Tcells/million CD4+ Tcells | Standard Deviation 0.9 |
Secondary
CMI Response in a Subset of Participants
Time frame: At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)
Secondary
CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells
CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV\_IC\_1 and RSV\_IC\_2 groups) and healthy participants (from RSV\_HA group).
Time frame: At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)
Population: Analysis was performed on PPS for CMI. Only participants with data available for CD8+ T cells for the specified groups at the specified timepoints were included in this analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| RSV_IC_2 Group | CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | Visit 1 | 33.9 Specific CD8+ Tcells/million CD8+ Tcells | Standard Deviation 1 |
| RSV_IC_2 Group | CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | Visit 2 | 16.0 Specific CD8+ Tcells/million CD8+ Tcells | Standard Deviation 1.2 |
| RSV_IC_2 Group | CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | Visit 3 | 21.7 Specific CD8+ Tcells/million CD8+ Tcells | Standard Deviation 0.8 |
| RSV_IC_2 Group | CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | Visit 4 | 12.0 Specific CD8+ Tcells/million CD8+ Tcells | Standard Deviation 1.1 |
| RSV_IC_2 Group | CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | Visit 4 | 16.9 Specific CD8+ Tcells/million CD8+ Tcells | Standard Deviation 0.9 |
| RSV_IC_2 Group | CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | Visit 1 | 8.2 Specific CD8+ Tcells/million CD8+ Tcells | Standard Deviation 1.1 |
| RSV_IC_2 Group | CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | Visit 3 | 22.3 Specific CD8+ Tcells/million CD8+ Tcells | Standard Deviation 1.1 |
| RSV_IC_2 Group | CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | Visit 2 | 8.7 Specific CD8+ Tcells/million CD8+ Tcells | Standard Deviation 1 |
| RSV_HA Group | CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | Visit 4 | 13.2 Specific CD8+ Tcells/million CD8+ Tcells | Standard Deviation 1.1 |
| RSV_HA Group | CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | Visit 2 | 13.0 Specific CD8+ Tcells/million CD8+ Tcells | Standard Deviation 1.2 |
| RSV_HA Group | CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | Visit 3 | 21.0 Specific CD8+ Tcells/million CD8+ Tcells | Standard Deviation 1.1 |
| RSV_HA Group | CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells | Visit 1 | 27.7 Specific CD8+ Tcells/million CD8+ Tcells | Standard Deviation 1 |
Secondary
Number of Participants Reporting Any AESIs Specific to Renal and Lung SOT Participants
AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV\_IC\_1 and RSV\_IC\_2 groups.
Time frame: From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)
Secondary
Number of Participants Reporting Any pIMDs and pIMDs Related to Study Intervention
pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.
Time frame: From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)
Secondary
Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention
pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.
Time frame: From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)
Population: Analysis was performed on the ES.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV_IC_2 Group | Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention | Any pIMD | 0 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention | Related pIMD | 0 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention | Any pIMD | 0 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention | Related pIMD | 0 Participants |
| RSV_HA Group | Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention | Any pIMD | 1 Participants |
| RSV_HA Group | Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention | Related pIMD | 0 Participants |
Secondary
Number of Participants Reporting Any SAEs, SAEs Related to Study Intervention and Fatal SAEs
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of 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: From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)
Secondary
Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of 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: From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)
Population: Analysis was performed on the ES.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV_IC_2 Group | Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs | Related SAEs | 1 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs | Any SAEs | 12 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs | Fatal SAEs | 0 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs | Related SAEs | 0 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs | Any SAEs | 18 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs | Fatal SAEs | 2 Participants |
| RSV_HA Group | Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs | Any SAEs | 3 Participants |
| RSV_HA Group | Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs | Fatal SAEs | 0 Participants |
| RSV_HA Group | Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs | Related SAEs | 0 Participants |
Secondary
Number Of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included pain, erythema (redness) and swelling, at the injection site. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
Time frame: Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)
Population: Analysis was performed on the Exposed set (ES) which included all participants who received the study intervention administration. Only participants with solicited administration site events at the specified timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Administration Site Events | Pain, Dosing at visit 1 | 95 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Administration Site Events | Swelling, Dosing at visit 1 | 8 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Administration Site Events | Erythema, Dosing at visit 1 | 8 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Administration Site Events | Erythema, Dosing at visit 1 | 14 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Administration Site Events | Erythema, Dosing at visit 3 | 10 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Administration Site Events | Swelling, Dosing at visit 3 | 6 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Administration Site Events | Pain, Dosing at visit 1 | 92 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Administration Site Events | Pain, Dosing at visit 3 | 81 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Administration Site Events | Swelling, Dosing at visit 1 | 11 Participants |
| RSV_HA Group | Number Of Participants Reporting Any Solicited Administration Site Events | Pain, Dosing at visit 1 | 95 Participants |
| RSV_HA Group | Number Of Participants Reporting Any Solicited Administration Site Events | Swelling, Dosing at visit 1 | 3 Participants |
| RSV_HA Group | Number Of Participants Reporting Any Solicited Administration Site Events | Erythema, Dosing at visit 1 | 11 Participants |
Secondary
Number Of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included fever (pyrexia), myalgia, arthralgia, headache, and fatigue. Fever is defined as body temperature greater or equal to (≥) 38 degrees Celsius (ºC). Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
Time frame: Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)
Population: Analysis was performed on the ES. Only participants with solicited systemic events at the specified timepoints were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Fatigue, Dosing at visit 1 | 41 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Headache, Dosing at visit 1 | 31 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Fever , Dosing at visit 1 | 2 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Arthralgia, Dosing at visit 1 | 19 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Myalgia, Dosing at visit 1 | 37 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Arthralgia, Dosing at visit 1 | 15 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Fatigue, Dosing at visit 3 | 47 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Fever , Dosing at visit 1 | 1 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Fever , Dosing at visit 3 | 2 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Myalgia, Dosing at visit 1 | 38 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Myalgia, Dosing at visit 3 | 38 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Arthralgia, Dosing at visit 3 | 19 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Headache, Dosing at visit 1 | 33 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Headache, Dosing at visit 3 | 30 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Solicited Systemic Events | Fatigue, Dosing at visit 1 | 45 Participants |
| RSV_HA Group | Number Of Participants Reporting Any Solicited Systemic Events | Headache, Dosing at visit 1 | 44 Participants |
| RSV_HA Group | Number Of Participants Reporting Any Solicited Systemic Events | Arthralgia, Dosing at visit 1 | 15 Participants |
| RSV_HA Group | Number Of Participants Reporting Any Solicited Systemic Events | Fatigue, Dosing at visit 1 | 48 Participants |
| RSV_HA Group | Number Of Participants Reporting Any Solicited Systemic Events | Myalgia, Dosing at visit 1 | 49 Participants |
| RSV_HA Group | Number Of Participants Reporting Any Solicited Systemic Events | Fever , Dosing at visit 1 | 1 Participants |
Secondary
Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration
An unsolicited AE is an AE that was not included in the list of solicited events. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
Time frame: Within 30 days (i.e., the day of vaccination and 29 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)
Population: Analysis was performed on the ES. Only participants with unsolicited AEs at the specified timepoints were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV_IC_2 Group | Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration | 21 Participants |
| RSV_IC_2 Group | Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration | 60 Participants |
| RSV_HA Group | Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration | 26 Participants |
Secondary
Number Of Participants With Any AEs Of Special Interest (AESIs) Specific To Renal And Lung SOT Participants
AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV\_IC\_1 and RSV\_IC\_2 groups.
Time frame: From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)
Population: Analysis was performed on the ES. Only SOT participants that had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV_IC_2 Group | Number Of Participants With Any AEs Of Special Interest (AESIs) Specific To Renal And Lung SOT Participants | 0 Participants |
| RSV_IC_2 Group | Number Of Participants With Any AEs Of Special Interest (AESIs) Specific To Renal And Lung SOT Participants | 1 Participants |
Secondary
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
Neutralizing titers were calculated as GMT and expressed in titers (Estimated Dilution 60 \[ED60\]).
Time frame: At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 in a subset of participants (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)
Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-A , Visit 1 | 807.0 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-A , Visit 2 | 1775.8 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-A , Visit 3 | 3990.8 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-A , Visit 4 | 4184.7 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-B, Visit 1 | 864.2 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-B, Visit 2 | 2325.3 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-B, Visit 3 | 5002.9 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-B, Visit 4 | 4461.7 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-A , Visit 3 | 4174.0 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-B, Visit 3 | 4834.7 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-A , Visit 4 | 5377.9 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-B, Visit 1 | 892.9 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-B, Visit 2 | 2603.1 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-A , Visit 1 | 814.1 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-A , Visit 2 | 2031.1 Titers (ED60) |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-B, Visit 4 | 5820.8 Titers (ED60) |
| RSV_HA Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-A , Visit 3 | 6822.5 Titers (ED60) |
| RSV_HA Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-A , Visit 2 | 6716.8 Titers (ED60) |
| RSV_HA Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-A , Visit 1 | 889.0 Titers (ED60) |
| RSV_HA Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-A , Visit 4 | 5707.0 Titers (ED60) |
| RSV_HA Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-B, Visit 3 | 9140.5 Titers (ED60) |
| RSV_HA Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-B, Visit 2 | 8113.6 Titers (ED60) |
| RSV_HA Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-B, Visit 1 | 1027.3 Titers (ED60) |
| RSV_HA Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups | RSV-B, Visit 4 | 6281.6 Titers (ED60) |
Secondary
RSV-A and RSV-B Serum Neutralizing Titers Expressed as GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
Neutralizing titers were calculated as GMT and expressed in titers (ED60).
Time frame: At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)
Secondary
RSV-A and RSV-B Serum Neutralizing Titers Expressed as MGI
Time frame: At Visit 5 (last dose +180-210 days) and Visit 6 (last dose + 350-380 days), each compared with Visit 1 (Day 1)
Secondary
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI
MGI was assessed at Visit 2 (in a subset of participants) over Visit 1 and Visit 3 over Visit 1 in RSV\_HA and pooled RSV\_IC (combined RSV\_IC\_1 and RSV\_IC\_2 groups), and at Visit 4 over Visit 1 in RSV\_IC\_1, RSV\_IC\_2, RSV\_HA groups.
Time frame: At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days), each compared to Visit 1 (Day 1)
Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-B, Visit 2 | 2.51 Ratio |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-B, Visit 3 | 5.72 Ratio |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-A, Visit 3 | 4.92 Ratio |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-B, Visit 4 | 5.22 Ratio |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-A, Visit 4 | 5.29 Ratio |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-A, Visit 2 | 2.14 Ratio |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-A, Visit 3 | 5.01 Ratio |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-B, Visit 2 | 2.54 Ratio |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-B, Visit 4 | 6.52 Ratio |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-B, Visit 3 | 5.34 Ratio |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-A, Visit 2 | 2.20 Ratio |
| RSV_IC_2 Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-A, Visit 4 | 6.53 Ratio |
| RSV_HA Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-B, Visit 4 | 6.35 Ratio |
| RSV_HA Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-A, Visit 2 | 7.59 Ratio |
| RSV_HA Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-A, Visit 3 | 7.82 Ratio |
| RSV_HA Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-A, Visit 4 | 6.55 Ratio |
| RSV_HA Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-B, Visit 2 | 8.59 Ratio |
| RSV_HA Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-B, Visit 3 | 8.80 Ratio |
| Pooled RSV_IC Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-A, Visit 2 | 2.17 Ratio |
| Pooled RSV_IC Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-B, Visit 3 | 5.53 Ratio |
| Pooled RSV_IC Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-A, Visit 3 | 4.96 Ratio |
| Pooled RSV_IC Group | RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI | RSV-B, Visit 2 | 2.53 Ratio |
Secondary
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups
Group GMT was assessed for RSV\_HA group over pooled RSV\_IC group (combined RSV\_IC\_1 and RSV\_IC\_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_HA and Pooled RSV\_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time frame: At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)
Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV_IC_2 Group | RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups | Visit 2 | 6689.9 Titers (ED60) |
| RSV_IC_2 Group | RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups | Visit 3 | 6653.8 Titers (ED60) |
| RSV_IC_2 Group | RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups | Visit 2 | 1902.8 Titers (ED60) |
| RSV_IC_2 Group | RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups | Visit 3 | 4113.0 Titers (ED60) |
Comparison: To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 2.95% CI: [2.26, 5.48]ANCOVA
Comparison: To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 3.95% CI: [1.28, 2.04]ANCOVA
Secondary
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups
Group GMT of RSV\_HA over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time frame: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_IC_2 Group | RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups | 4244.8 Titers (ED60) |
| RSV_IC_2 Group | RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups | 5541.6 Titers (ED60) |
Comparison: To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of study intervention (RSV\_IC\_1 group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 4.95% CI: [1.01, 1.68]ANCOVA
Secondary
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups
Group GMT of RSV\_IC\_2 over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_IC\_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time frame: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_IC_2 Group | RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups | 4041.9 Titers (ED60) |
| RSV_IC_2 Group | RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups | 5098.4 Titers (ED60) |
Comparison: To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of vaccine (RSV\_IC\_1 group) and participants that received lung or kidney solid organ transplant and 2 doses of vaccine (RSV\_IC\_2 group) for the RSV-A strain at Visit 4.95% CI: [0.94, 1.69]ANCOVA
Secondary
RSV-A Serum Neutralizing Titers Expressed as Group GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
Time frame: At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)
Secondary
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups
Group GMT of RSV\_HA over RSV\_IC\_2 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_2 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time frame: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_IC_2 Group | RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups | 5505.3 Titers (ED60) |
| RSV_IC_2 Group | RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups | 5615.7 Titers (ED60) |
Comparison: To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 2 doses of study intervention (RSV\_IC\_2 group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 4.95% CI: [0.8, 1.3]ANCOVA
Secondary
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups
Group GMT was assessed for RSV\_HA group over pooled RSV\_IC group (combined RSV\_IC\_1 and RSV\_IC\_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_HA and Pooled RSV\_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time frame: At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)
Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV_IC_2 Group | RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups | Visit 2 | 8238.7 Titers (ED60) |
| RSV_IC_2 Group | RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups | Visit 3 | 8545.5 Titers (ED60) |
| RSV_IC_2 Group | RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups | Visit 2 | 2442.6 Titers (ED60) |
| RSV_IC_2 Group | RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups | Visit 3 | 5106.9 Titers (ED60) |
Comparison: To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 2.95% CI: [2.28, 4.98]ANCOVA
Comparison: To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 3.95% CI: [1.32, 2.13]ANCOVA
Secondary
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups
Group GMT of RSV\_HA over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time frame: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_IC_2 Group | RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups | 4632.9 Titers (ED60) |
| RSV_IC_2 Group | RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups | 5973.5 Titers (ED60) |
Comparison: To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of study intervention (RSV\_IC\_1 group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 4.95% CI: [1, 1.65]ANCOVA
Secondary
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups
Group GMT ratio of RSV\_IC\_2 over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_IC\_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time frame: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_IC_2 Group | RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups | 4333.3 Titers (ED60) |
| RSV_IC_2 Group | RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups | 5550.5 Titers (ED60) |
Comparison: To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of vaccine (RSV\_IC\_1 group) and participants that received lung or kidney solid organ transplant and 2 doses of vaccine (RSV\_IC\_2 group) for the RSV-B strain at Visit 4.95% CI: [0.97, 1.7]ANCOVA
Secondary
RSV-B Serum Neutralizing Titers Expressed as Group GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
Time frame: At Visit 5 (last dose +180-210 days) and Visit 6 (last dose + 350-380 days)
Secondary
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups
Group GMT of RSV\_HA over RSV\_IC\_2 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_2 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time frame: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_IC_2 Group | RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups | 6090.6 Titers (ED60) |
| RSV_IC_2 Group | RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups | 6123.0 Titers (ED60) |
Comparison: To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 2 doses of study intervention (RSV\_IC\_2 group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 4.95% CI: [0.8, 1.26]ANCOVA