Respiratory Syncytial Virus Infections
Conditions
Keywords
Respiratory syncytial virus, Vaccine, Safety, Reactogenicity, Immunogenicity
Brief summary
The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.
Interventions
BIOLOGICALRSVPreF3 OA investigational vaccine
RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Open-label study. Both investigator and participant know the identity of the intervention assigned.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female participants ≥60 YOA at first vaccination, who live in the community (CD participants) or in a Long-term care facility (LTCF participants). * 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. * Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Patients 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.
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. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Hypersensitivity to latex. * Serious or unstable chronic illness. * Recurrent or un-controlled 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. * 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. * Any history of dementia or any medical condition that moderately or severely impairs cognition. Prior/Concomitant therapy * Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or planned use during the study period. * Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated, split virion and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination. * Previous vaccination with an RSV vaccine. * Administration of long-acting immune-modifying drugs or planned administration at any time during the study period. * Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine or planned administration during the study period. * Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine dose or planned administration during the study period. For corticosteroids, this will mean prednisone \>=20 mg/day, or equivalent. Inhaled and topical steroids are allowed. 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. Other exclusions * 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 participation in the trial until the study end. This includes: * Planned move during the study period to another LTCF that will prohibit participation in the trial until study end. * Planned move from the community to a LTCF that will prohibit participation in the trial until study end. * Participation of any study personnel or their immediate dependants, family, or household members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1 | At Day 1 | RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). |
| Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31 | At Day 31 | RSV-A neutralizing antibodies were given as GMTs and expressed as ED60. |
| Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6 | At Month 6 | RSV-A neutralizing antibodies were given as GMTs and expressed as ED60. |
| Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12 | At Month 12 | RSV-A neutralizing antibodies were given as GMTs and expressed as ED60. |
| Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1 | At Day 1 | RSV-B neutralizing antibodies measured as GMTs and expressed as ED60. |
| Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31 | At Day 31 | RSV-B neutralizing antibodies measured as GMTs and expressed as ED60. |
| Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6 | At Month 6 | RSV-B neutralizing antibodies measured as GMTs and expressed as ED60. |
| Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12 | At Month 12 | RSV-B neutralizing antibodies measured as GMTs and expressed as ED60. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Humoral Immune Response in Terms of RSVPreF3 Immunoglobulin G (IgG) Antibody Geometric Mean Concentrations (GMCs) at Day 1 | At Day 1 | Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by enzyme-linked immunosorbent assay (ELISA). The corresponding antibody GMC was expressed in Elisa Laboratory Units/milliliter (ELU/mL). |
| Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Day 31 | At Day 31 | Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. |
| Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 6 | At Month 6 | Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. |
| Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 12 | At Month 12 | Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. |
| Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 18 | At Month 18 | Month 18 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). |
| Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 24 | At Month 24 | Month 24 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). |
| Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 30 | At Month 30 | Month 30 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). |
| Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 36 | At Month 36 | Month 36 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). |
| Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 13 | At Month 13 | Month 13 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). |
| Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 25 | At Month 25 | Month 25 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). |
| Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 18 | At Month 18 | Month 18 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). |
| Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 24 | At Month 24 | Month 24 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). |
| Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 30 | At Month 30 | Month 30 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). |
| Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 36 | At Month 36 | Month 36 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). |
| Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 13 | At Month 13 | Month 13 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). |
| Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 25 | At Month 25 | Month 25 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). |
| Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 18 | At Month 18 | Month 18 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. |
| Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 24 | At Month 24 | Month 24 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. |
| Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 30 | At Month 30 | Month 30 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. |
| Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 36 | At Month 36 | Month 36 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. |
| Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 13 | At Month 13 | Month 13 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. |
| Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 25 | At Month 25 | Month 25 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. |
| Cell-Mediated Immunity (CMI) Response in Terms of Frequency of RSVPreF3-specific Cluster of Differentiation CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1 | At Day 1 | Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1 | At Day 1 | Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31 | At Day 31 | Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31 | At Day 31 | Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6 | At Month 6 | Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6 | At Month 6 | Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12 | At Month 12 | Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12 | At Month 12 | Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 18 | At Month 18 | Month 18 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 18 | At Month 18 | Month 18 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 24 | At Month 24 | Month 24 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 24 | At Month 24 | Month 24 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 30 | At Month 30 | Month 30 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 30 | At Month 30 | Month 30 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 36 | At Month 36 | Month 36 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 36 | At Month 36 | Month 36 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13 | At Month 13 | Month 13 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13 | At Month 13 | Month 13 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 25 | At Month 25 | Month 25 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 25 | At Month 25 | Month 25 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. |
| Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1 | During the 4-day follow up period after first vaccination (vaccine administered on Day 1) | The solicited administration-site events were erythema, pain and swelling at the injection site. |
| Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Month 12 | During the 4-day follow up period after vaccination (vaccine administered at Month 12) | Month 12 to Month 18 data will be disclosed during final posting. The solicited administration-site events were erythema, pain and swelling at the injection site. |
| Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Month 24 | During the 4-day follow up period after vaccination (vaccine administered at Month 24) | Month 24 data will be disclosed during final posting. The solicited administration-site events were erythema, pain and swelling at the injection site. |
| Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | During the 4-day follow up period after vaccination (vaccine administered on Day 1) | The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0 degree Celsius \[°C\]), headache and myalgia. |
| Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Month 12 | During the 4-day follow up period after vaccination (vaccine administered at Month 12) | Month 12 to Month 18 data will be disclosed during final posting. The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0°C), headache and myalgia. |
| Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Month 24 | During the 4-day follow up period after vaccination (vaccine administered at Month 24) | Month 24 data will be disclosed during final posting. The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0 degree Celsius (°C)), headache and myalgia. |
| Number of Participants With Any Unsolicited Adverse Events (AEs) Following Vaccination at Day 1 | During the 30-day follow up period after vaccination (vaccine administered on Day 1) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Participants With Any Unsolicited AEs Following Vaccination at Month 12 | During the 4-day follow up period after vaccination (vaccine administered at Month 12) | Month 12 to Month 18 data will be disclosed during final posting. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Participants With Any Unsolicited AEs Following Vaccination at Month 24 | During the 4-day follow up period after vaccination (vaccine administered at Month 24) | Month 24 data will be disclosed during final posting. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Participants With Serious Adverse Events (SAE) Following Vaccination at Day 1 | From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6) | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study participant. |
| Number of Participants With SAEs Following Vaccination at Month 12 | During the 4-day follow up period after vaccination (vaccine administered at Month 12) | Month 12 to Month 18 data will be disclosed during final posting. 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, or is a congenital anomaly/birth defect in the offspring of a study participant. |
| Number of Participants With SAEs Following Vaccination at Month 24 | During the 4-day follow up period after vaccination (vaccine administered at Month 24) | Month 24 data will be disclosed during final posting. 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, or is a congenital anomaly/birth defect in the offspring of a study participant. |
| Number of Participants Reporting Any Potential Immune-mediated Disease (pIMD) Following Vaccination at Day 1 | From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6) | 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. |
| Number of Participants Reporting Any pIMD Following Vaccination at Month 12 | During the 4-day follow up period after vaccination (vaccine administered at Month 12) | Month 12 to Month 18 data will be disclosed during final posting. 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. |
| Number of Participants Reporting Any pIMD Following Vaccination at Month 24 | During the 4-day follow up period after vaccination (vaccine administered at Month 24) | Month 24 data will be disclosed during final posting. 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. |
| Number of Participants With a Fatal SAE, Related SAE and Related pIMDs | From first vaccination (Day 1) up to study end (Month 36) | A fatal SAE is any untoward medical occurrence that results in death. A related SAE is an SAE considered to be causally related to the study intervention. A related pIMD is a pIMD considered to be causally related to the study intervention. The study is ongoing at the time of the results posting. Results for Months 18 up to study end (Month 36) will be updated during final posting. |
Countries
Finland, Germany, Japan, Taiwan, United States
Participant flow
Recruitment details
The demography, immunogenicity, reactogenicity and safety data currently presented is reported only for the first 12 months of the study timeline. The follow-up data (up to 36 months) will be updated during final posting.
Pre-assignment details
Out of 1720 participants enrolled in the study, 1653 participants received the study vaccination and were included in the Exposed Set.
Participants by arm
| Arm | Count |
|---|---|
| RSV_annual Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | 993 |
| RSV_flexible Revaccination Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | 329 |
| RSV_1dose Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). | 331 |
| Total | 1,653 |
Baseline characteristics
| Characteristic | Total | RSV_1dose | RSV_flexible Revaccination | RSV_annual |
|---|---|---|---|---|
| Age, Continuous | 70.0 YEARS STANDARD_DEVIATION 6.6 | 69.9 YEARS STANDARD_DEVIATION 6.7 | 69.9 YEARS STANDARD_DEVIATION 6.7 | 70.1 YEARS STANDARD_DEVIATION 6.6 |
| Race/Ethnicity, Customized American Indian Or Alaska Native | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 496 Participants | 98 Participants | 102 Participants | 296 Participants |
| Race/Ethnicity, Customized Black Or African American | 33 Participants | 6 Participants | 8 Participants | 19 Participants |
| Race/Ethnicity, Customized Other - Unspecified | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 1121 Participants | 226 Participants | 219 Participants | 676 Participants |
| Sex: Female, Male Female | 904 Participants | 180 Participants | 182 Participants | 542 Participants |
| Sex: Female, Male Male | 749 Participants | 151 Participants | 147 Participants | 451 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 993 | 1 / 329 | 3 / 331 |
| other Total, other adverse events | 744 / 993 | 251 / 329 | 253 / 331 |
| serious Total, serious adverse events | 46 / 993 | 16 / 329 | 19 / 331 |
Outcome results
Primary
Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1
RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Time frame: At Day 1
Population: Analysis was performed on the per-protocol (PP)-humoral immunity (HI) set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Day 1 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_annual | Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1 | 832.4 Titers (ED60) |
| RSV_flexible Revaccination | Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1 | 864.9 Titers (ED60) |
| RSV_1dose | Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1 | 896.8 Titers (ED60) |
Primary
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31
RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.
Time frame: At Day 31
Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Day 31 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_annual | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31 | 8827.2 Titers (ED60) |
| RSV_flexible Revaccination | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31 | 8906.6 Titers (ED60) |
| RSV_1dose | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31 | 9585.6 Titers (ED60) |
Primary
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12
RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.
Time frame: At Month 12
Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Month 12 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_annual | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12 | 2529.9 Titers (ED60) |
| RSV_flexible Revaccination | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12 | 2695.7 Titers (ED60) |
| RSV_1dose | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12 | 2800.1 Titers (ED60) |
Primary
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6
RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.
Time frame: At Month 6
Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Month 6 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_annual | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6 | 3465.2 Titers (ED60) |
| RSV_flexible Revaccination | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6 | 3600.1 Titers (ED60) |
| RSV_1dose | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6 | 4223.1 Titers (ED60) |
Primary
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1
RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
Time frame: At Day 1
Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Day 1 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_annual | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1 | 1138.7 Titers (ED60) |
| RSV_flexible Revaccination | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1 | 1325.9 Titers (ED60) |
| RSV_1dose | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1 | 1258.7 Titers (ED60) |
Primary
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31
RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
Time frame: At Day 31
Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Day 31 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_annual | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31 | 9219.7 Titers (ED60) |
| RSV_flexible Revaccination | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31 | 9955.2 Titers (ED60) |
| RSV_1dose | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31 | 9756.1 Titers (ED60) |
Primary
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12
RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
Time frame: At Month 12
Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Month 12 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_annual | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12 | 2671.4 Titers (ED60) |
| RSV_flexible Revaccination | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12 | 3015.4 Titers (ED60) |
| RSV_1dose | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12 | 2977.1 Titers (ED60) |
Primary
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6
RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
Time frame: At Month 6
Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Month 6 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_annual | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6 | 3886.4 Titers (ED60) |
| RSV_flexible Revaccination | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6 | 4484.6 Titers (ED60) |
| RSV_1dose | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6 | 4570.6 Titers (ED60) |
Secondary
Cell-Mediated Immunity (CMI) Response in Terms of Frequency of RSVPreF3-specific Cluster of Differentiation CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1
Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Day 1
Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Day 1, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RSV_annual | Cell-Mediated Immunity (CMI) Response in Terms of Frequency of RSVPreF3-specific Cluster of Differentiation CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1 | 202 CD4 atl2_7m/ million of CD4+ cells |
| RSV_flexible Revaccination | Cell-Mediated Immunity (CMI) Response in Terms of Frequency of RSVPreF3-specific Cluster of Differentiation CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1 | 143 CD4 atl2_7m/ million of CD4+ cells |
| RSV_1dose | Cell-Mediated Immunity (CMI) Response in Terms of Frequency of RSVPreF3-specific Cluster of Differentiation CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1 | 171 CD4 atl2_7m/ million of CD4+ cells |
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31
Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Day 31
Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Day 31, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RSV_annual | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31 | 1310 CD4 atl2_7m/ million of CD4+ cells |
| RSV_flexible Revaccination | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31 | 1292.5 CD4 atl2_7m/ million of CD4+ cells |
| RSV_1dose | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31 | 1570 CD4 atl2_7m/ million of CD4+ cells |
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12
Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 12
Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Month 12, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RSV_annual | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12 | 564 CD4 atl2_7m/ million of CD4+ cells |
| RSV_flexible Revaccination | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12 | 525 CD4 atl2_7m/ million of CD4+ cells |
| RSV_1dose | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12 | 671 CD4 atl2_7m/ million of CD4+ cells |
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13
Month 13 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 13
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 18
Month 18 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 18
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 24
Month 24 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 24
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 25
Month 25 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 25
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 30
Month 30 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 30
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 36
Month 36 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 36
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6
Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 6
Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Month 6, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RSV_annual | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6 | 662 CD4 atl2_7m/ million of CD4+ cells |
| RSV_flexible Revaccination | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6 | 644 CD4 atl2_7m/ million of CD4+ cells |
| RSV_1dose | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6 | 695 CD4 atl2_7m/ million of CD4+ cells |
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1
Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Day 1
Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Day 1, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RSV_annual | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1 | 33 CD8 atl2_7m/ million of CD8+ cells |
| RSV_flexible Revaccination | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1 | 32 CD8 atl2_7m/ million of CD8+ cells |
| RSV_1dose | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1 | 2 CD8 atl2_7m/ million of CD8+ cells |
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31
Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Day 31
Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Day 31, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RSV_annual | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31 | 26 CD8 atl2_7m/ million of CD8+ cells |
| RSV_flexible Revaccination | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31 | 58 CD8 atl2_7m/ million of CD8+ cells |
| RSV_1dose | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31 | 5 CD8 atl2_7m/ million of CD8+ cells |
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12
Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 12
Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Month 12, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RSV_annual | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12 | 1 CD8 atl2_7m/ million of CD8+ cells |
| RSV_flexible Revaccination | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12 | 18 CD8 atl2_7m/ million of CD8+ cells |
| RSV_1dose | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12 | 22 CD8 atl2_7m/ million of CD8+ cells |
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13
Month 13 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 13
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 18
Month 18 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 18
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 24
Month 24 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 24
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 25
Month 25 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 25
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 30
Month 30 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 30
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 36
Month 36 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 36
Secondary
CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6
Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Time frame: At Month 6
Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Month 6, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RSV_annual | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6 | 38 CD8 atl2_7m/ million of CD8+ cells |
| RSV_flexible Revaccination | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6 | 24.5 CD8 atl2_7m/ million of CD8+ cells |
| RSV_1dose | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6 | 26 CD8 atl2_7m/ million of CD8+ cells |
Secondary
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 13
Month 13 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Time frame: At Month 13
Secondary
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 18
Month 18 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Time frame: At Month 18
Secondary
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 24
Month 24 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Time frame: At Month 24
Secondary
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 25
Month 25 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Time frame: At Month 25
Secondary
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 30
Month 30 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Time frame: At Month 30
Secondary
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 36
Month 36 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Time frame: At Month 36
Secondary
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 13
Month 13 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Time frame: At Month 13
Secondary
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 18
Month 18 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Time frame: At Month 18
Secondary
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 24
Month 24 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Time frame: At Month 24
Secondary
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 25
Month 25 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Time frame: At Month 25
Secondary
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 30
Month 30 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Time frame: At Month 30
Secondary
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 36
Month 36 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Time frame: At Month 36
Secondary
Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Day 31
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
Time frame: At Day 31
Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Day 31 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_annual | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Day 31 | 86929.7 ELU/mL |
| RSV_flexible Revaccination | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Day 31 | 92664.7 ELU/mL |
| RSV_1dose | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Day 31 | 94249.4 ELU/mL |
Secondary
Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 12
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
Time frame: At Month 12
Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Month 12 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_annual | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 12 | 24733.5 ELU/mL |
| RSV_flexible Revaccination | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 12 | 26484.1 ELU/mL |
| RSV_1dose | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 12 | 27360.3 ELU/mL |
Secondary
Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 13
Month 13 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
Time frame: At Month 13
Secondary
Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 18
Month 18 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
Time frame: At Month 18
Secondary
Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 24
Month 24 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
Time frame: At Month 24
Secondary
Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 25
Month 25 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
Time frame: At Month 25
Secondary
Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 30
Month 30 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
Time frame: At Month 30
Secondary
Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 36
Month 36 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
Time frame: At Month 36
Secondary
Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 6
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.
Time frame: At Month 6
Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Month 6 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_annual | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 6 | 33855.9 ELU/mL |
| RSV_flexible Revaccination | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 6 | 35193.5 ELU/mL |
| RSV_1dose | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 6 | 36525.7 ELU/mL |
Secondary
Humoral Immune Response in Terms of RSVPreF3 Immunoglobulin G (IgG) Antibody Geometric Mean Concentrations (GMCs) at Day 1
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by enzyme-linked immunosorbent assay (ELISA). The corresponding antibody GMC was expressed in Elisa Laboratory Units/milliliter (ELU/mL).
Time frame: At Day 1
Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Day 1 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_annual | Humoral Immune Response in Terms of RSVPreF3 Immunoglobulin G (IgG) Antibody Geometric Mean Concentrations (GMCs) at Day 1 | 7334.7 ELU/mL |
| RSV_flexible Revaccination | Humoral Immune Response in Terms of RSVPreF3 Immunoglobulin G (IgG) Antibody Geometric Mean Concentrations (GMCs) at Day 1 | 7437.1 ELU/mL |
| RSV_1dose | Humoral Immune Response in Terms of RSVPreF3 Immunoglobulin G (IgG) Antibody Geometric Mean Concentrations (GMCs) at Day 1 | 7759 ELU/mL |
Secondary
Number of Participants Reporting Any pIMD Following Vaccination at Month 12
Month 12 to Month 18 data will be disclosed during final posting. 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: During the 4-day follow up period after vaccination (vaccine administered at Month 12)
Secondary
Number of Participants Reporting Any pIMD Following Vaccination at Month 24
Month 24 data will be disclosed during final posting. 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: During the 4-day follow up period after vaccination (vaccine administered at Month 24)
Secondary
Number of Participants Reporting Any Potential Immune-mediated Disease (pIMD) Following Vaccination at 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.
Time frame: From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6)
Population: The analysis was performed on the ES, which included all participants who received at least 1 dose of the study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV_annual | Number of Participants Reporting Any Potential Immune-mediated Disease (pIMD) Following Vaccination at Day 1 | 0 Participants |
| RSV_flexible Revaccination | Number of Participants Reporting Any Potential Immune-mediated Disease (pIMD) Following Vaccination at Day 1 | 1 Participants |
| RSV_1dose | Number of Participants Reporting Any Potential Immune-mediated Disease (pIMD) Following Vaccination at Day 1 | 0 Participants |
Secondary
Number of Participants With a Fatal SAE, Related SAE and Related pIMDs
A fatal SAE is any untoward medical occurrence that results in death. A related SAE is an SAE considered to be causally related to the study intervention. A related pIMD is a pIMD considered to be causally related to the study intervention. The study is ongoing at the time of the results posting. Results for Months 18 up to study end (Month 36) will be updated during final posting.
Time frame: From first vaccination (Day 1) up to study end (Month 36)
Secondary
Number of Participants With Any Unsolicited Adverse Events (AEs) Following Vaccination at Day 1
An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 30-day follow up period after vaccination (vaccine administered on Day 1)
Population: The analysis was performed on the ES, which included all participants who received at least 1 dose of the study intervention and for whom safety data was available for 30 days following vaccination at Day 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV_annual | Number of Participants With Any Unsolicited Adverse Events (AEs) Following Vaccination at Day 1 | 125 Participants |
| RSV_flexible Revaccination | Number of Participants With Any Unsolicited Adverse Events (AEs) Following Vaccination at Day 1 | 45 Participants |
| RSV_1dose | Number of Participants With Any Unsolicited Adverse Events (AEs) Following Vaccination at Day 1 | 55 Participants |
Secondary
Number of Participants With Any Unsolicited AEs Following Vaccination at Month 12
Month 12 to Month 18 data will be disclosed during final posting. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 4-day follow up period after vaccination (vaccine administered at Month 12)
Secondary
Number of Participants With Any Unsolicited AEs Following Vaccination at Month 24
Month 24 data will be disclosed during final posting. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 4-day follow up period after vaccination (vaccine administered at Month 24)
Secondary
Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1
The solicited administration-site events were erythema, pain and swelling at the injection site.
Time frame: During the 4-day follow up period after first vaccination (vaccine administered on Day 1)
Population: The analysis was performed on the Exposed Set (ES), which included all participants who received at least 1 dose of the study intervention and for whom solicited administration-site data was available for the specific duration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV_annual | Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1 | Pain | 595 Participants |
| RSV_annual | Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1 | Erythema | 99 Participants |
| RSV_annual | Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1 | Swelling | 75 Participants |
| RSV_flexible Revaccination | Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1 | Pain | 201 Participants |
| RSV_flexible Revaccination | Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1 | Erythema | 38 Participants |
| RSV_flexible Revaccination | Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1 | Swelling | 33 Participants |
| RSV_1dose | Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1 | Erythema | 22 Participants |
| RSV_1dose | Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1 | Swelling | 16 Participants |
| RSV_1dose | Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1 | Pain | 200 Participants |
Secondary
Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Month 12
Month 12 to Month 18 data will be disclosed during final posting. The solicited administration-site events were erythema, pain and swelling at the injection site.
Time frame: During the 4-day follow up period after vaccination (vaccine administered at Month 12)
Secondary
Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Month 24
Month 24 data will be disclosed during final posting. The solicited administration-site events were erythema, pain and swelling at the injection site.
Time frame: During the 4-day follow up period after vaccination (vaccine administered at Month 24)
Secondary
Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1
The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0 degree Celsius \[°C\]), headache and myalgia.
Time frame: During the 4-day follow up period after vaccination (vaccine administered on Day 1)
Population: The analysis was performed on the ES, which included all participants who received at least 1 dose of the study intervention and for whom solicited systemic data was available for the specific duration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV_annual | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Headache | 187 Participants |
| RSV_annual | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Fever | 13 Participants |
| RSV_annual | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Arthralgia | 157 Participants |
| RSV_annual | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Fatigue | 307 Participants |
| RSV_annual | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Myalgia | 336 Participants |
| RSV_flexible Revaccination | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Fever | 5 Participants |
| RSV_flexible Revaccination | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Arthralgia | 49 Participants |
| RSV_flexible Revaccination | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Fatigue | 100 Participants |
| RSV_flexible Revaccination | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Headache | 70 Participants |
| RSV_flexible Revaccination | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Myalgia | 107 Participants |
| RSV_1dose | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Myalgia | 109 Participants |
| RSV_1dose | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Headache | 79 Participants |
| RSV_1dose | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Arthralgia | 49 Participants |
| RSV_1dose | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Fever | 7 Participants |
| RSV_1dose | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | Fatigue | 110 Participants |
Secondary
Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Month 12
Month 12 to Month 18 data will be disclosed during final posting. The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0°C), headache and myalgia.
Time frame: During the 4-day follow up period after vaccination (vaccine administered at Month 12)
Secondary
Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Month 24
Month 24 data will be disclosed during final posting. The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0 degree Celsius (°C)), headache and myalgia.
Time frame: During the 4-day follow up period after vaccination (vaccine administered at Month 24)
Secondary
Number of Participants With SAEs Following Vaccination at Month 12
Month 12 to Month 18 data will be disclosed during final posting. 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, or is a congenital anomaly/birth defect in the offspring of a study participant.
Time frame: During the 4-day follow up period after vaccination (vaccine administered at Month 12)
Secondary
Number of Participants With SAEs Following Vaccination at Month 24
Month 24 data will be disclosed during final posting. 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, or is a congenital anomaly/birth defect in the offspring of a study participant.
Time frame: During the 4-day follow up period after vaccination (vaccine administered at Month 24)
Secondary
Number of Participants With Serious Adverse Events (SAE) Following Vaccination at 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, or is a congenital anomaly/birth defect in the offspring of a study participant.
Time frame: From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6)
Population: The analysis was performed on the ES, which included all participants who received at least 1 dose of the study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV_annual | Number of Participants With Serious Adverse Events (SAE) Following Vaccination at Day 1 | 36 Participants |
| RSV_flexible Revaccination | Number of Participants With Serious Adverse Events (SAE) Following Vaccination at Day 1 | 16 Participants |
| RSV_1dose | Number of Participants With Serious Adverse Events (SAE) Following Vaccination at Day 1 | 15 Participants |