Respiratory Syncytial Virus Infections
Conditions
Keywords
Respiratory syncytial virus, Lower respiratory tract disease, Efficacy study, Adults aged 60 years and above
Brief summary
This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.
Detailed description
Dose 1 Period will be conducted in 2 parts: Part 1: Participants in RSVPreF3 groups will receive lots 1, 2 and 3 of the investigational vaccine before Season 1. Part 2: Will be initiated when the vaccine lots in part 1 are exhausted at the study sites and participants in RSVPreF3 group will receive lot 4 of the investigational vaccine before Season 1.
Interventions
BIOLOGICALPlacebo
Placebo administered intramuscularly into the deltoid of the non-dominant arm at day 1 and before Season 2 to the Placebo Group, and before Season 2 to the participants of the RSVPreF3 Group, that are re-randomized to the RSV\_1 dose group.
BIOLOGICALRSVPreF3 OA vaccine
RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at Day 1 in the RSVPreF3 group, and before Season 2 to the participants of the RSVPreF3 group that are re-randomized to the RSV\_annual group.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is an observer blind study.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A male or female ≥ 60 YOA at the time of first vaccination, who live in the community (community dwelling 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. Note: In case of physical incapacity that would preclude the self-completion of the diary cards and/or questionnaires, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant's health status while answering diaries and/or questionnaires or make decisions on behalf of the participant * 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. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.
Exclusion criteria
Medical conditions * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required). * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Hypersensitivity to latex. * Serious or unstable chronic illness. * Any history of dementia or any medical condition that moderately or severely impairs cognition. Note: If deemed necessary for clinical evaluation, the investigator can use tools such as Mini-Mental State Exam (MMSE), Mini-Cog or Montreal Cognitive Assessment (MoCA) to determine cognition levels of the participant. * Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active 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. Prior/Concomitant therapy * Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the first study vaccine administration, 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 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 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 study vaccine administration 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 (drug or medical device). 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 participating in the trial until 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. * Planned leave or holiday of 4 consecutive weeks or more during the RSV seasons\* covered by the study, that would prohibit the reporting of ARI cases and attendance to ARI visit. * RSV seasons are from October to April in NH and from March to September in SH.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine | From Day 15 post-vaccination up to end of season 1 in the Northern Hemisphere (NH) [a median of approximately 6.7 months (6.9 months in NH and 3.5 months in Southern Hemisphere [SH])] | First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine | From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the NH (assessed approximately over 2 and 3 years in NH) | Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine was assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition. |
| Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine | From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH, and 2.5-3 years in SH) | Efficacy of a single dose of the RSVPreF3 OA vaccine was assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition. |
| Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following 1 Annual Revaccination Dose | From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH, and 2.5-3 years in SH) | Efficacy of a single dose and 1 annual revaccination dose of the RSVPreF3 OA vaccine was assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition. |
| Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Human Metapneumovirus (hMPV) up to the End of Season 1 Following a Single Dose of the RSVPreF3 OA Vaccine | From Day 15 post-vaccination up to end of season 1 in the SH [a median of approximately 11.5 months (11.6 months in NH and 9.1 months in SH)] | — |
| Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH) | Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, in the following age categories: greater than or equal to (≥) 65 years of age (YOA), ≥70 YOA and ≥80 YOA. |
| Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | From Day 15 post first dose or start of the RSV season to the first occurrence of RSV-confirmed LRTD at each RSV season (assessed approximately over 7 months at each season [Seasons 1 and 2 in SH, Seasons 1, 2 and 3 in NH]) | Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by RSV season as follows: VE after each season includes the first occurrence of episodes reported from Day 15 post vaccination at first season, and for the next seasons, excluding analysis of participants who already reported a case in the previous season. The RSV season may be extended based on epidemiology data. |
| Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | From Day 15 post first dose and each revaccination dose up to next dose or end of study (assessed approximately over a year after each vaccination [at Year 1, Year 2 and Year 3]) | Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by years after vaccination as follows: VE at each year includes the first occurrence of episodes reported from Day 14 post vaccination at first year, and for the next years, excluding analysis of participants who already reported a case in the previous year. |
| Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | From Day 15 post first dose to the first occurrence of RSV LRTD (assessed approximately over 3 years in the NH and 2.5-3 years in SH) | — |
| Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Using Charlson Comorbidity Index Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH) | Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated LRTD episode by baseline comorbidities using Charlson Comorbidity Index. Low/medium Risk = Participants with co-morbidity score at baseline less than or equal to 3 (Charlson Index); High Risk = Participants with co-morbidity score at baseline greater than 3 (Charlson Index). |
| Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH) | Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated LRTD episode by baseline comorbidities of interest divided into 2: cardiorespiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, any chronic respiratory or pulmonary disease, and endocrinometabolic conditions such as diabetes mellitus type 1 or 2, chronic heart failure and advanced liver or renal disease. |
| Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH) | Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and /or B associated LRTD episode according to the case definition, by baseline frailty status of frail, pre-frail and fit. Frail = Participants with a walking speed of less than (\<) 0.4 meters per second (m/s) or who were not able to perform the test; Pre-Frail = Participants with a walking speed between 0.4-0.99 m/s; Fit = Participants with a walking speed of ≥1 m/s. |
| Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH) | Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated severe LRTD episode. Case definition for RSV-confirmed severe LRTD: An RT-PCR confirmed case of RSV-associated severe LRTD is characterized by presence of lower respiratory signs or an LRTD episode assessed as severe by the investigator (Severe LRTD case definition 1) or presence of an LRTD with need for oxygen supplementation or need for positive airway pressure therapy or need for other types of mechanical ventilation (Severe LRTD case definition 2) and with at least one RSV positive swab detected by RT-PCR. |
| Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH) | Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV confirmed A and/or B associated ARI episode. A case of RT-PCR confirmed RSV-associated ARI is characterized by the presence of respiratory symptoms/signs for at least 24 hours OR respiratory symptom/sign + systemic symptom/sign for at least 24 hours with at least one RSV-positive swab detected by RT-PCR. |
| Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | From Day 15 post first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH) | Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against any ARI and any LRTD. |
| Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH) | RSV infection was confirmed by RT-PCR. |
| Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH) | A diagnosis of respiratory disease included: acute respiratory infections, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. |
| Number of Complications Related to RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH) | RSV infection was confirmed by RT-PCR. |
| Number of Complications Related to Any ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH) | RSV infection was confirmed by RT-PCR. |
| Maximum Influenza Patient-Reported Outcome (Flu-PRO) Chest Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | During the first 7 days from the onset of ARI symptoms (assessed from Day 15 post first vaccination dose until end of study [approximately 3 years in NH and 2.5-3 years in SH]) | For this outcome measure, the Health Related -Quality of life (HR-QOL) score is measured by Flu-PRO questionnaire version 2.0. The Flu-PRO is a 32 items daily diary, which assesses influenza signs across 6 body systems- nose, throat, eyes, chest/respiratory, gastrointestinal and body/systemic. The objective of this outcome measure was to present data only for chest/respiratory system after a single dose and after annual revaccination. The FLU-PRO score was computed as the mean score across questionaire items for chest/respiratory body system, with the scores ranging from 0 (symptom free) to 4 (very severe symptoms). |
| Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | During the first 7 days from the onset of ARI symptoms (assessed from Day 15 post first vaccination dose until end of study [approximately 3 years in NH and 2.5-3 years in SH]) | The Flu-PRO questionnaire version 2.0 is a 32 items daily diary, which assesses influenza signs across 6 body systems- nose, throat, eyes, chest/respiratory, gastrointestinal and body/systemic. The FLU-PRO total score was computed as the mean score across all 32 items of the questionaire for all 6 body systems, with the total scores ranging from 0 (symptom free) to 4 (very severe symptoms). |
| EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | At the ARI visit (assessed from Day 15 post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH) | The EQ-5D is a general health utility questionnaire with health states, defined through 5 dimensions- mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. A participant who responds 1 (no problem/no symptom) to all 5 items has a profile 11111 and similarly a participant who responds 3 (the highest level of difficulty or symptom) to all items has a profile 33333. The health states indicated in these 5 dimensions are converted and presented as a single mean index value as recommended by EuroQol group, where values range from 0 (worst) to 1 (full health). |
| Least Square Mean of Short Form-12 (SF-12) Health Survey for Participants With RT-PCR Confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | At the ARI visit (assessed from one-month post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH) | SF-12 is a health survey with 12 questions, covering 8 domains- physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Summary scores are computed from these domains for the physical and mental component. The total score of the SF-12 questionnaire is evaluated on a scale from 0 to 100, with a higher score indicating a better perceived health-related quality of life. |
| Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | From Day 15 post first dose to end of Season 1, from 15 days post-second dose administration to end of Season 2, and from start to end of Season 3 [all seasons summing approximately 3 years in NH and 2.5-3 years in SH] | The duration in days of RT-PCR confirmed RSV A and/or B ARI and LRTD episodes are described. |
| Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | From Day 15 post-dose 1 administration up to end of season 1 in the SH [a median of approximately 11.5 months (11.6 months in NH and 9.1 months in SH)] | RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes were reported. Fever was defined as a temperature ≥38.0 degrees Celsius (°C) by any route. |
| Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | From Day 15 post-dose 2 administration up to end of Season 2 in SH (a median of approximately 11.9 months [11.9 months in NH and 7.5 months in SH]) | RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes were reported. Fever was defined as a temperature ≥38.0 degrees Celsius (°C) by any route. |
| Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | From start of Season 3 up to end of Season 3 in NH (a median of approximately 7 months) | RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes were reported. Fever was defined as a temperature ≥38.0 degrees Celsius (°C) by any route. |
| Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | From Day 15 post-dose 1 administration up to end of season 1 in the SH [a median of approximately 11.5 months (11.6 months in NH and 9.1 months in SH)] | RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes were reported. Fever was defined as a temperature ≥38.0°C by any route. |
| Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | From Day 15 post-dose 2 administration up to end of Season 2 in SH (a median of approximately 11.9 months [11.9 months in NH and 7.5 months in SH]) | RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes were reported. Fever was defined as a temperature ≥38.0°C by any route. |
| Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | From start of Season 3 up to end of Season 3 in NH (a median of approximately 7 months) | RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes were reported. Fever was defined as a temperature ≥38.0°C by any route. |
| Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity | Assessed during the study period (approximately 3 years for NH and 2.5-3 years for SH) | RSV A and/or B ARI and LRTD episodes were assessed as mild, moderate or severe by the investigator after the single dose and after annual revaccination. Mild = an ARI/LRTD episode which is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. Moderate = an ARI/LRTD episode which is sufficiently discomforting to interfere with normal everyday activities. Severe = an ARI/LRTD episode which prevents normal, everyday activities. |
| RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations | At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH) | The RSVPreF3 IgG antibody concentrations are expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EU/mL). |
| RSV A Neutralizing Antibody Titers | At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH) | The RSV A neutralizing antibody titers are expressed as geometric mean titers (GMTs). |
| RSV B Neutralizing Antibody Titers | At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH) | RSV B neutralizing antibodies are expressed as GMTs. |
| Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH]) | Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade or relation to study vaccination. Grade 3 = an event which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling. |
| Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH]) | Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade or relation to study vaccination. Grade 3 = an event which prevented normal, everyday activities. The assessed solicited systemic events include arthralgia, fatigue, fever, headache and myalgia. Fever is defined as a temperature ≥ 38.0°C by any route. Grade 3 fever is defined as temperature \>39°C by any route. |
| Number of Days With Solicited Administration Site Adverse Events | During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH]) | — |
| Number of Days With Solicited Systemic Adverse Events | During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH]) | — |
| Number of Participants With Any Unsolicited AEs | During the 30-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH) | An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside of the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any= occurrence of the event regardless of intensity grade or relation to the study vaccination. |
| Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following a Single Dose of the RSVPreF3 OA Vaccine | From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemisphere [NH] (assessed approximately over 2 and 3 years in NH) | Efficacy of a single dose of the RSVPreF3 OA vaccine was assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition. |
| Number of Participants With Potential Immune Mediated Diseases (pIMDs) | From the day of the vaccination up to 6 months after each vaccination (first vaccination: at Day 1, second vaccination: at pre-season 2 and the third vaccination: at pre-season 3 -only applicable for participants in NH]) | pIMDs aredefined as a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any= occurrence of any pIMD regardless of intensity grade or relation to the study vaccination. |
| Number of Participants With Related SAEs | From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH) | Related SAEs that occur throughout the study are assessed. Related SAEs= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator. |
| Number of Participants With Fatal SAEs | From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH) | Fatal SAEs that occur throughout the study are assessed. Fatal SAEs= Any SAEs leading to deaths. |
| Number of Participants With Related pIMDs | From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH) | Related pIMD = pIMD assessed by the investigator as related to the study vaccination. |
| Number of Participants With Serious Adverse Events (SAEs) | From the day of the vaccination up to 6 months after each vaccination (first vaccination: at Day 1, second vaccination: at pre-season 2 and the third vaccination: at pre-season 3 -only applicable for participants in NH]) | An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to study vaccination. |
Countries
Australia, Belgium, Canada, Estonia, Finland, Germany, Italy, Japan, Mexico, New Zealand, Poland, Russia, South Africa, South Korea, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
Out of 26675 participants enrolled in the study, 24972 received study intervention and were included in the Exposed set and started the study.
Participants by arm
| Arm | Count |
|---|---|
| RSVPreF3 Group Participants received a single dose of the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants in this group were re-randomized into 2 as: a group that received placebo every subsequent year, and a group that received an additional dose of RSVPreF3 OA vaccine every subsequent year of the study. | 12,469 |
| Placebo Group Participants received 1 dose of placebo at Day 1 and an additional dose of placebo every subsequent year of the study. | 12,503 |
| Total | 24,972 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 442 | 441 |
| Overall Study | Consent withdrawal, not due to a (S)AE | 1,715 | 1,726 |
| Overall Study | Lost to Follow-up | 448 | 465 |
| Overall Study | Migrated/moved from the study area | 201 | 184 |
| Overall Study | Other | 298 | 326 |
Baseline characteristics
| Characteristic | RSVPreF3 Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 69.5 YEARS STANDARD_DEVIATION 6.5 | 69.6 YEARS STANDARD_DEVIATION 6.4 | 69.5 YEARS STANDARD_DEVIATION 6.5 |
| Race/Ethnicity, Customized All Other Races | 55 Participants | 41 Participants | 96 Participants |
| Race/Ethnicity, Customized Asian | 953 Participants | 956 Participants | 1909 Participants |
| Race/Ethnicity, Customized Black or African American | 1064 Participants | 1101 Participants | 2165 Participants |
| Race/Ethnicity, Customized Other | 508 Participants | 469 Participants | 977 Participants |
| Race/Ethnicity, Customized White | 9889 Participants | 9936 Participants | 19825 Participants |
| Sex: Female, Male Female | 6489 Participants | 6429 Participants | 12918 Participants |
| Sex: Female, Male Male | 5980 Participants | 6074 Participants | 12054 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 265 / 12,503 | 111 / 6,226 | 120 / 6,243 |
| other Total, other adverse events | 5,837 / 12,503 | 3,663 / 6,226 | 3,826 / 6,243 |
| serious Total, serious adverse events | 1,660 / 12,503 | 799 / 6,226 | 796 / 6,243 |
Outcome results
Primary
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine
First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR.
Time frame: From Day 15 post-vaccination up to end of season 1 in the Northern Hemisphere (NH) [a median of approximately 6.7 months (6.9 months in NH and 3.5 months in Southern Hemisphere [SH])]
Population: Analysis was performed on the modified Exposed Set (mES), which included all participants who received at least the first dose of the study intervention and who do not report an RSV-confirmed Acute Respiratory Illness (ARI) prior to 2 weeks (\<Day 15) after each vaccination (mES-RSV set). Only participants with data available at specified timepoints were included in analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine | 7 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine | 40 Participants |
Comparison: To demonstrate the vaccine efficacy (VE) efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD during the first season in adults ≥ 60 YOA96.95% CI: [57.89, 94.08]Poisson regression method
Secondary
Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes
The duration in days of RT-PCR confirmed RSV A and/or B ARI and LRTD episodes are described.
Time frame: From Day 15 post first dose to end of Season 1, from 15 days post-second dose administration to end of Season 2, and from start to end of Season 3 [all seasons summing approximately 3 years in NH and 2.5-3 years in SH]
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| RSVPreF3 Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV LRTD, Season 1 | 15.5 Days |
| RSVPreF3 Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV ARI, Season 1 | 12.0 Days |
| Placebo Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV LRTD, Season 1 | 20.0 Days |
| Placebo Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV LRTD, Season 3 | 17.5 Days |
| Placebo Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV ARI, Season 1 | 15.0 Days |
| Placebo Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV ARI, Season 2 | 16.0 Days |
| Placebo Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV LRTD, Season 2 | 16.0 Days |
| Placebo Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV ARI, Season 3 | 16.0 Days |
| RSV_1_dose Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV LRTD, Season 3 | 16.5 Days |
| RSV_1_dose Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV LRTD, Season 2 | 17.0 Days |
| RSV_1_dose Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV ARI, Season 3 | 16.0 Days |
| RSV_1_dose Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV ARI, Season 2 | 14.0 Days |
| RSV_annual Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV ARI, Season 2 | 13.0 Days |
| RSV_annual Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV ARI, Season 3 | 10.0 Days |
| RSV_annual Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV LRTD, Season 2 | 14.0 Days |
| RSV_annual Group | Duration in Days of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes | RT-PCR-confirmed RSV LRTD, Season 3 | 12.0 Days |
Secondary
EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
The EQ-5D is a general health utility questionnaire with health states, defined through 5 dimensions- mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. A participant who responds 1 (no problem/no symptom) to all 5 items has a profile 11111 and similarly a participant who responds 3 (the highest level of difficulty or symptom) to all items has a profile 33333. The health states indicated in these 5 dimensions are converted and presented as a single mean index value as recommended by EuroQol group, where values range from 0 (worst) to 1 (full health).
Time frame: At the ARI visit (assessed from Day 15 post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| RSVPreF3 Group | EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | At ARI visit (Single dose) | 0.8164 Scores on a scale | Standard Error 0.0258 |
| RSVPreF3 Group | EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | At ARI visit (Annual revaccination) | 0.8377 Scores on a scale | Standard Error 0.0259 |
| Placebo Group | EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | At ARI visit (Annual revaccination) | 0.7966 Scores on a scale | Standard Error 0.0197 |
| Placebo Group | EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | At ARI visit (Single dose) | 0.7886 Scores on a scale | Standard Error 0.0197 |
Secondary
Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
The Flu-PRO questionnaire version 2.0 is a 32 items daily diary, which assesses influenza signs across 6 body systems- nose, throat, eyes, chest/respiratory, gastrointestinal and body/systemic. The FLU-PRO total score was computed as the mean score across all 32 items of the questionaire for all 6 body systems, with the total scores ranging from 0 (symptom free) to 4 (very severe symptoms).
Time frame: During the first 7 days from the onset of ARI symptoms (assessed from Day 15 post first vaccination dose until end of study [approximately 3 years in NH and 2.5-3 years in SH])
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| RSVPreF3 Group | Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Day 1 to Day 7 (Single dose) | 0.85 Scores on a scale | Standard Error 0.07 |
| RSVPreF3 Group | Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Day 1 to Day 7 (Annual revaccination) | 0.81 Scores on a scale | Standard Error 0.07 |
| Placebo Group | Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Day 1 to Day 7 (Single dose) | 0.92 Scores on a scale | Standard Error 0.06 |
| Placebo Group | Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Day 1 to Day 7 (Annual revaccination) | 0.90 Scores on a scale | Standard Error 0.06 |
Secondary
Least Square Mean of Short Form-12 (SF-12) Health Survey for Participants With RT-PCR Confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
SF-12 is a health survey with 12 questions, covering 8 domains- physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Summary scores are computed from these domains for the physical and mental component. The total score of the SF-12 questionnaire is evaluated on a scale from 0 to 100, with a higher score indicating a better perceived health-related quality of life.
Time frame: At the ARI visit (assessed from one-month post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| RSVPreF3 Group | Least Square Mean of Short Form-12 (SF-12) Health Survey for Participants With RT-PCR Confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | At ARI visit (Single dose) | 59.43 Scores on a scale | Standard Error 4.07 |
| RSVPreF3 Group | Least Square Mean of Short Form-12 (SF-12) Health Survey for Participants With RT-PCR Confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | At ARI visit (Annual revaccination) | 63.65 Scores on a scale | Standard Error 4.15 |
| Placebo Group | Least Square Mean of Short Form-12 (SF-12) Health Survey for Participants With RT-PCR Confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | At ARI visit (Single dose) | 57.51 Scores on a scale | Standard Error 3.15 |
| Placebo Group | Least Square Mean of Short Form-12 (SF-12) Health Survey for Participants With RT-PCR Confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | At ARI visit (Annual revaccination) | 59.02 Scores on a scale | Standard Error 3.18 |
Secondary
Maximum Influenza Patient-Reported Outcome (Flu-PRO) Chest Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
For this outcome measure, the Health Related -Quality of life (HR-QOL) score is measured by Flu-PRO questionnaire version 2.0. The Flu-PRO is a 32 items daily diary, which assesses influenza signs across 6 body systems- nose, throat, eyes, chest/respiratory, gastrointestinal and body/systemic. The objective of this outcome measure was to present data only for chest/respiratory system after a single dose and after annual revaccination. The FLU-PRO score was computed as the mean score across questionaire items for chest/respiratory body system, with the scores ranging from 0 (symptom free) to 4 (very severe symptoms).
Time frame: During the first 7 days from the onset of ARI symptoms (assessed from Day 15 post first vaccination dose until end of study [approximately 3 years in NH and 2.5-3 years in SH])
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RSVPreF3 Group | Maximum Influenza Patient-Reported Outcome (Flu-PRO) Chest Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Chest / Respiratory (Single dose) | 1.60 Scores on a scale | Standard Deviation 0.89 |
| RSVPreF3 Group | Maximum Influenza Patient-Reported Outcome (Flu-PRO) Chest Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Chest / Respiratory (Annual revaccination) | 1.50 Scores on a scale | Standard Deviation 0.87 |
| Placebo Group | Maximum Influenza Patient-Reported Outcome (Flu-PRO) Chest Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Chest / Respiratory (Single dose) | 1.97 Scores on a scale | Standard Deviation 0.88 |
| Placebo Group | Maximum Influenza Patient-Reported Outcome (Flu-PRO) Chest Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Chest / Respiratory (Annual revaccination) | 1.96 Scores on a scale | Standard Deviation 0.89 |
Secondary
Number of Complications Related to Any ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study
RSV infection was confirmed by RT-PCR.
Time frame: From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Complications Related to Any ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Complications related to any ARI (Single dose), during season | 438 Participants |
| RSVPreF3 Group | Number of Complications Related to Any ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Complications related to any ARI (Single dose), up to end of study | 620 Participants |
| RSVPreF3 Group | Number of Complications Related to Any ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Complications related to any ARI (Annual revaccination), up to end of study | 579 Participants |
| RSVPreF3 Group | Number of Complications Related to Any ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Complications related to any ARI (Annual revaccination), during season | 417 Participants |
| Placebo Group | Number of Complications Related to Any ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Complications related to any ARI (Annual revaccination), up to end of study | 823 Participants |
| Placebo Group | Number of Complications Related to Any ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Complications related to any ARI (Annual revaccination), during season | 660 Participants |
| Placebo Group | Number of Complications Related to Any ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Complications related to any ARI (Single dose), during season | 695 Participants |
| Placebo Group | Number of Complications Related to Any ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Complications related to any ARI (Single dose), up to end of study | 863 Participants |
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-8.29, 12.42]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [-4.05, 16.39]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-0.68, 21.31]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [0.32, 22.58]Poisson regression method
Secondary
Number of Complications Related to RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study
RSV infection was confirmed by RT-PCR.
Time frame: From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Complications Related to RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Related to RT-PCR-confirmed RSV ARI (Single dose), up to end of study | 12 Participants |
| RSVPreF3 Group | Number of Complications Related to RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Related to RT-PCR-confirmed RSV ARI (Annual revaccination), up to end of study | 11 Participants |
| RSVPreF3 Group | Number of Complications Related to RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Related to RT-PCR-confirmed RSV ARI (Single dose), during season | 9 Participants |
| RSVPreF3 Group | Number of Complications Related to RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Related to RT-PCR-confirmed RSV ARI (Annual revaccination), during season | 9 Participants |
| Placebo Group | Number of Complications Related to RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Related to RT-PCR-confirmed RSV ARI (Annual revaccination), during season | 39 Participants |
| Placebo Group | Number of Complications Related to RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Related to RT-PCR-confirmed RSV ARI (Single dose), up to end of study | 50 Participants |
| Placebo Group | Number of Complications Related to RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Related to RT-PCR-confirmed RSV ARI (Single dose), during season | 43 Participants |
| Placebo Group | Number of Complications Related to RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Related to RT-PCR-confirmed RSV ARI (Annual revaccination), up to end of study | 46 Participants |
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV- ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [28.91, 82.15]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV-ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [28.5, 83.2]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV- ARI during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [28.56, 85.47]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV-ARI during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [21.45, 84.29]Poisson regression method
Secondary
Number of Days With Solicited Administration Site Adverse Events
Time frame: During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH])
Population: Analysis was performed on a subset of participants from the solicited safety set (SSS), which included participants who received at least the first dose of the study intervention and with the solicited administration site events diary card data available after the corresponding vaccination for the specified duration. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| RSVPreF3 Group | Number of Days With Solicited Administration Site Adverse Events | Pain, Dose 1 | 1.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Administration Site Adverse Events | Swelling, Dose 2 | 2.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Administration Site Adverse Events | Erythema, Dose 1 | 4.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Administration Site Adverse Events | Pain, Dose 2 | 1.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Administration Site Adverse Events | Erythema, Dose 2 | 4.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Administration Site Adverse Events | Swelling, Dose 1 | 4.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Administration Site Adverse Events | Pain, Dose 3 (NH) | 2.0 Days |
| Placebo Group | Number of Days With Solicited Administration Site Adverse Events | Pain, Dose 2 | 1.0 Days |
| Placebo Group | Number of Days With Solicited Administration Site Adverse Events | Erythema, Dose 2 | 2.0 Days |
| Placebo Group | Number of Days With Solicited Administration Site Adverse Events | Erythema, Dose 1 | 3.0 Days |
| Placebo Group | Number of Days With Solicited Administration Site Adverse Events | Pain, Dose 1 | 2.0 Days |
| Placebo Group | Number of Days With Solicited Administration Site Adverse Events | Pain, Dose 3 (NH) | 1.0 Days |
| Placebo Group | Number of Days With Solicited Administration Site Adverse Events | Swelling, Dose 1 | 3.0 Days |
| Placebo Group | Number of Days With Solicited Administration Site Adverse Events | Swelling, Dose 3 (NH) | 49.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Administration Site Adverse Events | Swelling, Dose 2 | 3.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Administration Site Adverse Events | Pain, Dose 3 (NH) | 2.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Administration Site Adverse Events | Erythema, Dose 2 | 3.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Administration Site Adverse Events | Swelling, Dose 3 (NH) | 1.5 Days |
| RSV_1_dose Group | Number of Days With Solicited Administration Site Adverse Events | Swelling, Dose 1 | 3.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Administration Site Adverse Events | Erythema, Dose 1 | 3.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Administration Site Adverse Events | Pain, Dose 1 | 2.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Administration Site Adverse Events | Pain, Dose 2 | 2.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Administration Site Adverse Events | Erythema, Dose 3 (NH) | 3.0 Days |
Secondary
Number of Days With Solicited Systemic Adverse Events
Time frame: During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH])
Population: Analysis was performed on a subset of participants from the solicited safety set (SSS), which included participants who received at least the first dose of the study intervention and with the solicited systemic events diary card data available after the corresponding vaccination for the specified duration. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Fatigue, Dose 3 (NH) | 1.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Arthralgia, Dose 2 | 2.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Headache, Dose 1 | 1.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Fever, Dose 1 | 1.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Arthralgia, Dose 1 | 2.5 Days |
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Fever, Dose 3 (NH) | 1.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Fever, Dose 2 | 2.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Myalgia, Dose 1 | 1.5 Days |
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Arthralgia, Dose 3 (NH) | 4.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Myalgia, Dose 3 (NH) | 2.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Headache, Dose 3 (NH) | 1.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Fatigue, Dose 1 | 1.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Fatigue, Dose 2 | 2.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Myalgia, Dose 2 | 2.0 Days |
| RSVPreF3 Group | Number of Days With Solicited Systemic Adverse Events | Headache, Dose 2 | 2.0 Days |
| Placebo Group | Number of Days With Solicited Systemic Adverse Events | Headache, Dose 3 (NH) | 1.0 Days |
| Placebo Group | Number of Days With Solicited Systemic Adverse Events | Arthralgia, Dose 1 | 2.0 Days |
| Placebo Group | Number of Days With Solicited Systemic Adverse Events | Arthralgia, Dose 2 | 2.0 Days |
| Placebo Group | Number of Days With Solicited Systemic Adverse Events | Arthralgia, Dose 3 (NH) | 2.0 Days |
| Placebo Group | Number of Days With Solicited Systemic Adverse Events | Fatigue, Dose 2 | 1.5 Days |
| Placebo Group | Number of Days With Solicited Systemic Adverse Events | Fatigue, Dose 3 (NH) | 2.5 Days |
| Placebo Group | Number of Days With Solicited Systemic Adverse Events | Fever, Dose 1 | 1.0 Days |
| Placebo Group | Number of Days With Solicited Systemic Adverse Events | Fever, Dose 2 | 1.0 Days |
| Placebo Group | Number of Days With Solicited Systemic Adverse Events | Headache, Dose 1 | 1.0 Days |
| Placebo Group | Number of Days With Solicited Systemic Adverse Events | Headache, Dose 2 | 1.0 Days |
| Placebo Group | Number of Days With Solicited Systemic Adverse Events | Fatigue, Dose 1 | 2.0 Days |
| Placebo Group | Number of Days With Solicited Systemic Adverse Events | Myalgia, Dose 1 | 2.0 Days |
| Placebo Group | Number of Days With Solicited Systemic Adverse Events | Myalgia, Dose 2 | 1.5 Days |
| Placebo Group | Number of Days With Solicited Systemic Adverse Events | Myalgia, Dose 3 (NH) | 3.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Systemic Adverse Events | Myalgia, Dose 3 (NH) | 2.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Systemic Adverse Events | Headache, Dose 2 | 1.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Systemic Adverse Events | Arthralgia, Dose 3 (NH) | 4.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Systemic Adverse Events | Myalgia, Dose 2 | 2.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Systemic Adverse Events | Headache, Dose 3 (NH) | 2.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Systemic Adverse Events | Arthralgia, Dose 2 | 1.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Systemic Adverse Events | Fatigue, Dose 1 | 2.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Systemic Adverse Events | Myalgia, Dose 1 | 2.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Systemic Adverse Events | Fever, Dose 2 | 1.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Systemic Adverse Events | Fever, Dose 1 | 1.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Systemic Adverse Events | Fatigue, Dose 3 (NH) | 2.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Systemic Adverse Events | Arthralgia, Dose 1 | 2.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Systemic Adverse Events | Headache, Dose 1 | 1.0 Days |
| RSV_1_dose Group | Number of Days With Solicited Systemic Adverse Events | Fatigue, Dose 2 | 2.0 Days |
Secondary
Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study
A diagnosis of respiratory disease included: acute respiratory infections, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system.
Time frame: From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease or related complication (Annual revaccination), during seasons | 119 Participants |
| RSVPreF3 Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease (Single dose), up to end of study | 167 Participants |
| RSVPreF3 Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease (Annual revaccination), up to end of study | 163 Participants |
| RSVPreF3 Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease or related complication (Single dose), up to end of study | 179 Participants |
| RSVPreF3 Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease (Single dose), during seasons | 121 Participants |
| RSVPreF3 Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease (Annual revaccination), during seasons | 114 Participants |
| RSVPreF3 Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease or related complication (Annual revaccination), up to end of study | 171 Participants |
| RSVPreF3 Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease or related complication (Single dose), during seasons | 131 Participants |
| Placebo Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease or related complication (Annual revaccination), up to end of study | 217 Participants |
| Placebo Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease (Annual revaccination), during seasons | 163 Participants |
| Placebo Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease (Single dose), during seasons | 174 Participants |
| Placebo Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease or related complication (Annual revaccination), during seasons | 169 Participants |
| Placebo Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease (Single dose), up to end of study | 221 Participants |
| Placebo Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease or related complication (Single dose), up to end of study | 230 Participants |
| Placebo Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease (Annual revaccination), up to end of study | 208 Participants |
| Placebo Group | Number of Hospitalizations Due to Any Respiratory Diseases or Due to a Complication Related to Any Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | Any respiratory disease or related complication (Single dose), during seasons | 180 Participants |
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-25.43, 17.49]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory disease during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-28.26, 14.61]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine95% CI: [-28.2, 16.38]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory diseases during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [-27.55, 15.98]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the RSV season in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-23.52, 23.99]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory disease during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-28.56, 19.7]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [-22.14, 26]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [-21.73, 25.48]Poisson regression method
Secondary
Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study
RSV infection was confirmed by RT-PCR.
Time frame: From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease (Single dose), during season | 2 Participants |
| RSVPreF3 Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease (Single dose), up to end of study | 2 Participants |
| RSVPreF3 Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease (Annual revaccination),during season | 0 Participants |
| RSVPreF3 Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease or related complication (Single dose), up to end of study | 2 Participants |
| RSVPreF3 Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease or related complication (Single dose), during season | 2 Participants |
| RSVPreF3 Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease (Annual revaccination), up to end of study | 0 Participants |
| RSVPreF3 Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease or related complication (Annual revaccination), during season | 0 Participants |
| RSVPreF3 Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease or related complication (Annual revaccination), up to end of study | 0 Participants |
| Placebo Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease or related complication (Annual revaccination), during season | 4 Participants |
| Placebo Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease (Single dose), during season | 4 Participants |
| Placebo Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease or related complication (Single dose), during season | 4 Participants |
| Placebo Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease (Annual revaccination),during season | 4 Participants |
| Placebo Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease or related complication (Annual revaccination), up to end of study | 6 Participants |
| Placebo Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease (Single dose), up to end of study | 6 Participants |
| Placebo Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease or related complication (Single dose), up to end of study | 6 Participants |
| Placebo Group | Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses up to End of Study | RSV respiratory disease (Annual revaccination), up to end of study | 6 Participants |
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-184.45, 95.19]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-184.45, 95.19]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [11.56, 100]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [11.56, 100]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the RSV seson in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-457.67, 93.12]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the RSV season in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-457.67, 93.12]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the RSV season in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [-54.53, 100]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the RSV season in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [-54.53, 100]Poisson regression method
Secondary
Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events
Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade or relation to study vaccination. Grade 3 = an event which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling.
Time frame: During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH])
Population: Analysis was performed on a subset of participants from the solicited safety set (SSS), which included participants who received at least the first dose of the study intervention and with the solicited administration site events diary card data available after the corresponding vaccination for the specified duration. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 2, Grade 3 | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 2, Grade 3 | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 3 (NH), Any | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 2, Any | 1 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 2, Any | 51 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 3 (NH), Grade 3 | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 2, Any | 2 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 1, Any | 81 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 1, Grade 3 | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 3 (NH), Any | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 1, Grade 3 | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 1, Any | 10 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 1, Any | 7 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 1, Grade 3 | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 3 (NH), Grade 3 | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 3 (NH), Grade 3 | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 3 (NH), Any | 7 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema , Dose 2, Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 3 (NH), Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 1, Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 2, Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 2, Any | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 2, Any | 1 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema , Dose 2, Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 3 (NH), Any | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 3 (NH), Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 1, Any | 267 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 1, Grade 3 | 6 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 2, Any | 30 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 3 (NH), Any | 3 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 3 (NH), Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 1, Any | 25 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 1, Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 2, Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 3 (NH), Any | 1 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 1, Any | 41 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 3 (NH), Any | 25 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 1, Grade 3 | 2 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 3 (NH), Any | 2 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 1, Any | 30 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 2, Grade 3 | 6 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 1, Any | 28 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 3 (NH), Grade 3 | 0 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 1, Grade 3 | 3 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 3 (NH), Grade 3 | 1 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 1, Grade 3 | 2 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 1, Any | 268 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 3 (NH), Grade 3 | 0 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 3 (NH), Any | 2 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Swelling, Dose 2, Any | 23 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema , Dose 2, Grade 3 | 3 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 2, Grade 3 | 2 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Erythema, Dose 2, Any | 31 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events | Pain, Dose 2, Any | 169 Participants |
Secondary
Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events
Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade or relation to study vaccination. Grade 3 = an event which prevented normal, everyday activities. The assessed solicited systemic events include arthralgia, fatigue, fever, headache and myalgia. Fever is defined as a temperature ≥ 38.0°C by any route. Grade 3 fever is defined as temperature \>39°C by any route.
Time frame: During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH])
Population: Analysis was performed on a subset of participants from the solicited safety set (SSS), which included participants who received at least the first dose of the study intervention and with the solicited systemic events diary card data available after the corresponding vaccination for the specified duration. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 1, Grade 3 | 5 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 2, Any | 60 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 2, Any | 48 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 1, Any | 111 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 2, Grade 3 | 2 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 3 (NH), Any | 12 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 3 (NH), Grade 3 | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 3 (NH), Any | 5 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 2, Grade 3 | 7 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 3 (NH), Any | 1 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 3 (NH), Grade 3 | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 2, Any | 80 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 1, Any | 141 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 3 (NH), Any | 5 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 1, Grade 3 | 3 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 1, Grade 3 | 4 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 3 (NH), Grade 3 | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 2, Grade 3 | 3 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 3 (NH), Grade 3 | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 1, Any | 3 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 3 (NH), Grade 3 | 0 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 3 (NH), Any | 9 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 1, Grade 3 | 1 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 2, Any | 52 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 2, Grade 3 | 4 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 2, Any | 4 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 2, Grade 3 | 2 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 1, Any | 56 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 1, Any | 72 Participants |
| RSVPreF3 Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 1, Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 3 (NH), Any | 6 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 2, Any | 20 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 2, Any | 1 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 3 (NH), Any | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 3 (NH), Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 3 (NH), Grade 3 | 1 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 1, Any | 14 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 1, Grade 3 | 1 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 1, Any | 74 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 1, Grade 3 | 5 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 2, Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 3 (NH), Any | 2 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 3 (NH), Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 1, Any | 143 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 2, Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 3 (NH), Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 1, Any | 116 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 1, Grade 3 | 6 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 2, Any | 41 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 2, Grade 3 | 1 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 1, Grade 3 | 6 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 2, Any | 44 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 2, Grade 3 | 2 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 3 (NH), Any | 8 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 1, Any | 127 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 1, Grade 3 | 5 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 2, Any | 20 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 2, Grade 3 | 0 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 3 (NH), Any | 3 Participants |
| Placebo Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 3 (NH), Grade 3 | 0 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 2, Grade 3 | 2 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 1, Any | 4 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 3 (NH), Grade 3 | 0 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 2, Any | 82 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 3 (NH), Any | 0 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 1, Grade 3 | 9 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 3 (NH), Any | 5 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 3 (NH), Grade 3 | 0 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 2, Any | 98 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 1, Grade 3 | 6 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 2, Any | 6 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 2, Grade 3 | 3 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 2, Any | 73 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 3 (NH), Grade 3 | 0 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 3 (NH), Any | 7 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 1, Any | 153 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 3 (NH), Grade 3 | 0 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 2, Grade 3 | 0 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 3 (NH), Any | 5 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 2, Grade 3 | 2 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 1, Any | 123 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 3 (NH), Grade 3 | 0 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 2, Any | 55 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 2, Grade 3 | 3 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Arthralgia, Dose 1, Any | 84 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 1, Any | 128 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Headache, Dose 1, Grade 3 | 5 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fatigue, Dose 3 (NH), Any | 9 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Fever, Dose 1, Grade 3 | 0 Participants |
| RSV_1_dose Group | Number of Participants With Any and Grade 3 Solicited Systemic Adverse Events | Myalgia, Dose 1, Grade 3 | 7 Participants |
Secondary
Number of Participants With Any Unsolicited AEs
An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside of the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any= occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: During the 30-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH)
Population: Analysis is performed on the Exposed Set, which included all participants that received at least the first vaccination. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With Any Unsolicited AEs | Any unsolicited AE (post Dose 2) | 1570 Participants |
| RSVPreF3 Group | Number of Participants With Any Unsolicited AEs | Any unsolicited AE (post Dose 1) | 2334 Participants |
| RSVPreF3 Group | Number of Participants With Any Unsolicited AEs | Any unsolicited AE (post Dose 3) | 422 Participants |
| Placebo Group | Number of Participants With Any Unsolicited AEs | Any unsolicited AE (post Dose 2) | 824 Participants |
| Placebo Group | Number of Participants With Any Unsolicited AEs | Any unsolicited AE (post Dose 1) | 2149 Participants |
| Placebo Group | Number of Participants With Any Unsolicited AEs | Any unsolicited AE (post Dose 3) | 233 Participants |
| RSV_1_dose Group | Number of Participants With Any Unsolicited AEs | Any unsolicited AE (post Dose 1) | 2136 Participants |
| RSV_1_dose Group | Number of Participants With Any Unsolicited AEs | Any unsolicited AE (post Dose 3) | 397 Participants |
| RSV_1_dose Group | Number of Participants With Any Unsolicited AEs | Any unsolicited AE (post Dose 2) | 1456 Participants |
Secondary
Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1
RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes were reported. Fever was defined as a temperature ≥38.0 degrees Celsius (°C) by any route.
Time frame: From Day 15 post-dose 1 administration up to end of season 1 in the SH [a median of approximately 11.5 months (11.6 months in NH and 9.1 months in SH)]
Population: Analysis was performed on the mES. Only participants with data available for symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes at specified timepoints were included in analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Wheezing (new or increased) | 5 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Crackles | 1 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Cough (new or increased) | 36 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Headache | 20 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Respiratory rate ≥20 breaths/minute | 3 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Rhonchi | 1 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Nasal Congestion | 28 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Rhinorrhea | 32 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Feverishness | 8 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Low or decreased oxygen saturation | 1 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Sore Throat | 26 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Fever | 2 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Decreased appetite | 13 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Sputum (new or increased) | 20 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Need for oxygen supplementation | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Need for positive airway pressure therapy | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Fatigue | 22 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Need of other types of mechanical ventilation | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Shortness of breath or dyspnea (new or increased) | 7 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Other symptoms or signs | 7 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Body aches | 12 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Other symptoms or signs | 22 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Sore Throat | 76 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Wheezing (new or increased) | 25 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Body aches | 40 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Need for oxygen supplementation | 4 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Rhinorrhea | 93 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Cough (new or increased) | 101 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Sputum (new or increased) | 75 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Shortness of breath or dyspnea (new or increased) | 35 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Crackles | 6 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Rhonchi | 13 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Respiratory rate ≥20 breaths/minute | 11 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Low or decreased oxygen saturation | 9 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Fever | 8 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Feverishness | 24 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Fatigue | 67 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Headache | 55 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Decreased appetite | 42 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Need for positive airway pressure therapy | 0 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Need of other types of mechanical ventilation | 0 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 1 | Nasal Congestion | 83 Participants |
Secondary
Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2
RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes were reported. Fever was defined as a temperature ≥38.0 degrees Celsius (°C) by any route.
Time frame: From Day 15 post-dose 2 administration up to end of Season 2 in SH (a median of approximately 11.9 months [11.9 months in NH and 7.5 months in SH])
Population: Analysis was performed on the modified Exposed set for Dose 2 (mES-Dose 2), which included all participants who received the first and second doses of the study intervention, and who did not report an RSV-confirmed ARI prior to Day 15 after each vaccination. Only participants with data available for symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes at specified timepoints were included in analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Feverishness | 64 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Shortness of breath or dyspnea (new or increased) | 79 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Nasal Congestion | 162 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Sputum (new or increased) | 150 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Wheezing (new or increased) | 56 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Low or decreased oxygen saturation | 8 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Rhinorrhea | 186 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Respiratory rate ≥20 breaths/minute | 21 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Crackles | 19 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Need of other types of mechanical ventilation | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Rhonchi | 32 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Fever | 21 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Need for oxygen supplementation | 1 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Cough (new or increased) | 201 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Decreased appetite | 85 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Need for positive airway pressure therapy | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Headache | 124 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Sore Throat | 147 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Body aches | 91 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Other symptoms or signs | 48 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Fatigue | 145 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Low or decreased oxygen saturation | 1 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Sore Throat | 43 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Sputum (new or increased) | 39 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Respiratory rate ≥20 breaths/minute | 5 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Fatigue | 34 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Nasal Congestion | 43 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Rhinorrhea | 52 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Cough (new or increased) | 55 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Shortness of breath or dyspnea (new or increased) | 17 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Wheezing (new or increased) | 15 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Crackles | 2 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Rhonchi | 8 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Fever | 5 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Feverishness | 13 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Body aches | 27 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Headache | 36 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Decreased appetite | 20 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Need for oxygen supplementation | 1 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Need for positive airway pressure therapy | 1 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Need of other types of mechanical ventilation | 0 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Other symptoms or signs | 12 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Need for oxygen supplementation | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Rhinorrhea | 39 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Fatigue | 33 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Nasal Congestion | 31 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Sputum (new or increased) | 29 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Body aches | 24 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Need of other types of mechanical ventilation | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Need for positive airway pressure therapy | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Headache | 28 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Decreased appetite | 18 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Low or decreased oxygen saturation | 4 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Crackles | 3 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Feverishness | 15 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Rhonchi | 7 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Wheezing (new or increased) | 10 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Respiratory rate ≥20 breaths/minute | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Shortness of breath or dyspnea (new or increased) | 19 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Cough (new or increased) | 41 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Other symptoms or signs | 14 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Fever | 7 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 2 | Sore Throat | 33 Participants |
Secondary
Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3
RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes were reported. Fever was defined as a temperature ≥38.0 degrees Celsius (°C) by any route.
Time frame: From start of Season 3 up to end of Season 3 in NH (a median of approximately 7 months)
Population: Analysis was performed on the mES-Dose 2. Only participants with data available for symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes at specified timepoints were included in analysis. Only participants in NH were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Nasal Congestion | 101 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Sore Throat | 76 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Shortness of breath or dyspnea (new or increased) | 42 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Crackles | 10 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Fever | 10 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Feverishness | 32 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Fatigue | 85 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Headache | 66 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Decreased appetite | 52 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Rhinorrhea | 98 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Cough (new or increased) | 111 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Sputum (new or increased) | 86 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Wheezing (new or increased) | 32 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Rhonchi | 16 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Respiratory rate ≥20 breaths/minute | 9 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Low or decreased oxygen saturation | 11 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Body aches | 56 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Need for oxygen supplementation | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Need for positive airway pressure therapy | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Need of other types of mechanical ventilation | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Other symptoms or signs | 35 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Headache | 16 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Nasal Congestion | 25 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Decreased appetite | 13 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Sore Throat | 17 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Cough (new or increased) | 27 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Need for positive airway pressure therapy | 0 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Low or decreased oxygen saturation | 1 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Wheezing (new or increased) | 6 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Crackles | 2 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Respiratory rate ≥20 breaths/minute | 3 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Fever | 2 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Rhinorrhea | 26 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Sputum (new or increased) | 23 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Feverishness | 14 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Fatigue | 21 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Rhonchi | 8 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Body aches | 16 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Other symptoms or signs | 6 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Need of other types of mechanical ventilation | 0 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Shortness of breath or dyspnea (new or increased) | 10 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Need for oxygen supplementation | 1 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Cough (new or increased) | 18 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Nasal Congestion | 15 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Rhinorrhea | 17 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Sore Throat | 14 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Decreased appetite | 12 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Sputum (new or increased) | 10 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Shortness of breath or dyspnea (new or increased) | 5 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Need of other types of mechanical ventilation | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Crackles | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Need for oxygen supplementation | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Rhonchi | 2 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Other symptoms or signs | 9 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Respiratory rate ≥20 breaths/minute | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Need for positive airway pressure therapy | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Wheezing (new or increased) | 3 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Low or decreased oxygen saturation | 3 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Fever | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Feverishness | 6 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Fatigue | 15 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Headache | 12 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B ARI Episodes During Season 3 | Body aches | 10 Participants |
Secondary
Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1
RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes were reported. Fever was defined as a temperature ≥38.0°C by any route.
Time frame: From Day 15 post-dose 1 administration up to end of season 1 in the SH [a median of approximately 11.5 months (11.6 months in NH and 9.1 months in SH)]
Population: Analysis was performed on the mES-RSV. Only participants with data available for symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes at specified timepoints were included in analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Sore Throat | 5 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Body aches | 5 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Cough (new or increased) | 10 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Shortness of breath or dyspnea (new or increased) | 4 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Wheezing (new or increased) | 5 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Crackles | 1 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Nasal Congestion | 7 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Rhonchi | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Respiratory rate ≥20 breaths/minute | 3 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Low or decreased oxygen saturation | 1 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Fever | 1 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Feverishness | 2 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Fatigue | 6 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Headache | 4 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Decreased appetite | 7 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Need for oxygen supplementation | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Need for positive airway pressure therapy | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Need of other types of mechanical ventilation | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Other symptoms or signs | 2 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Rhinorrhea | 9 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Sputum (new or increased) | 8 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Fever | 8 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Sputum (new or increased) | 36 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Rhonchi | 13 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Other symptoms or signs | 12 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Body aches | 22 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Sore Throat | 33 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Feverishness | 16 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Cough (new or increased) | 47 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Need for positive airway pressure therapy | 0 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Shortness of breath or dyspnea (new or increased) | 29 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Fatigue | 37 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Wheezing (new or increased) | 24 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Nasal Congestion | 38 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Headache | 27 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Crackles | 6 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Need of other types of mechanical ventilation | 0 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Decreased appetite | 26 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Respiratory rate ≥20 breaths/minute | 10 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Rhinorrhea | 38 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Low or decreased oxygen saturation | 8 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 1 | Need for oxygen supplementation | 4 Participants |
Secondary
Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2
RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes were reported. Fever was defined as a temperature ≥38.0°C by any route.
Time frame: From Day 15 post-dose 2 administration up to end of Season 2 in SH (a median of approximately 11.9 months [11.9 months in NH and 7.5 months in SH])
Population: Analysis was performed on the mES-Dose 2. Only participants with data available for symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes at specified timepoints were included in analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Wheezing (new or increased) | 56 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Respiratory rate ≥20 breaths/minute | 21 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Body aches | 53 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Crackles | 19 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Nasal Congestion | 90 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Fatigue | 86 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Rhonchi | 31 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Need of other types of mechanical ventilation | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Feverishness | 44 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Low or decreased oxygen saturation | 8 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Need for positive airway pressure therapy | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Fever | 13 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Sore Throat | 79 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Cough (new or increased) | 106 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Need for oxygen supplementation | 1 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Sputum (new or increased) | 95 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Other symptoms or signs | 28 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Decreased appetite | 47 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Shortness of breath or dyspnea (new or increased) | 72 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Rhinorrhea | 96 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Headache | 70 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Need for positive airway pressure therapy | 1 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Rhinorrhea | 20 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Sore Throat | 17 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Rhonchi | 5 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Nasal Congestion | 20 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Cough (new or increased) | 21 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Sputum (new or increased) | 19 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Shortness of breath or dyspnea (new or increased) | 14 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Wheezing (new or increased) | 15 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Crackles | 2 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Respiratory rate ≥20 breaths/minute | 5 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Low or decreased oxygen saturation | 1 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Fever | 3 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Feverishness | 7 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Fatigue | 16 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Body aches | 15 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Headache | 17 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Decreased appetite | 13 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Need for oxygen supplementation | 1 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Need of other types of mechanical ventilation | 0 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Other symptoms or signs | 3 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Wheezing (new or increased) | 10 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Sore Throat | 15 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Body aches | 11 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Shortness of breath or dyspnea (new or increased) | 13 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Other symptoms or signs | 5 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Headache | 14 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Sputum (new or increased) | 17 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Need of other types of mechanical ventilation | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Decreased appetite | 11 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Cough (new or increased) | 20 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Rhinorrhea | 19 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Need for oxygen supplementation | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Low or decreased oxygen saturation | 4 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Nasal Congestion | 15 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Fever | 3 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Respiratory rate ≥20 breaths/minute | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Rhonchi | 7 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Feverishness | 8 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Crackles | 3 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Need for positive airway pressure therapy | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 2 | Fatigue | 15 Participants |
Secondary
Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3
RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes were reported. Fever was defined as a temperature ≥38.0°C by any route.
Time frame: From start of Season 3 up to end of Season 3 in NH (a median of approximately 7 months)
Population: Analysis was performed on the mES-Dose 2. Only participants with data available for symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes at specified timepoints were included in analysis. Only participants in NH were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Body aches | 39 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Crackles | 10 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Other symptoms or signs | 22 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Fatigue | 49 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Rhonchi | 16 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Need for positive airway pressure therapy | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Feverishness | 22 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Respiratory rate ≥20 breaths/minute | 9 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Cough (new or increased) | 60 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Fever | 6 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Low or decreased oxygen saturation | 11 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Rhinorrhea | 50 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Need for oxygen supplementation | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Sputum (new or increased) | 53 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Nasal Congestion | 54 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Decreased appetite | 33 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Shortness of breath or dyspnea (new or increased) | 38 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Need of other types of mechanical ventilation | 0 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Headache | 41 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Wheezing (new or increased) | 32 Participants |
| RSVPreF3 Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Sore Throat | 42 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Need for positive airway pressure therapy | 0 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Nasal Congestion | 13 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Rhinorrhea | 14 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Sore Throat | 9 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Cough (new or increased) | 15 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Sputum (new or increased) | 14 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Shortness of breath or dyspnea (new or increased) | 9 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Wheezing (new or increased) | 5 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Crackles | 2 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Rhonchi | 8 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Respiratory rate ≥20 breaths/minute | 3 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Low or decreased oxygen saturation | 1 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Fever | 0 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Feverishness | 8 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Fatigue | 13 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Body aches | 10 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Headache | 10 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Decreased appetite | 11 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Need for oxygen supplementation | 1 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Need of other types of mechanical ventilation | 0 Participants |
| Placebo Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Other symptoms or signs | 4 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Wheezing (new or increased) | 3 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Rhinorrhea | 4 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Body aches | 5 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Shortness of breath or dyspnea (new or increased) | 4 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Other symptoms or signs | 3 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Headache | 5 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Sputum (new or increased) | 5 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Need of other types of mechanical ventilation | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Decreased appetite | 3 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Cough (new or increased) | 6 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Nasal Congestion | 4 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Need for oxygen supplementation | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Low or decreased oxygen saturation | 3 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Respiratory rate ≥20 breaths/minute | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Sore Throat | 5 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Fever | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Rhonchi | 2 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Feverishness | 3 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Crackles | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Need for positive airway pressure therapy | 0 Participants |
| RSV_1_dose Group | Number of Participants With Each Reported Symptom/Sign and Supportive Therapy Use Associated With of RT-PCR Confirmed RSV A and/or B LRTD Episodes During Season 3 | Fatigue | 6 Participants |
Secondary
Number of Participants With Fatal SAEs
Fatal SAEs that occur throughout the study are assessed. Fatal SAEs= Any SAEs leading to deaths.
Time frame: From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Population: Analysis was performed on the Exposed Set. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSVPreF3 Group | Number of Participants With Fatal SAEs | 265 Participants |
| Placebo Group | Number of Participants With Fatal SAEs | 111 Participants |
| RSV_1_dose Group | Number of Participants With Fatal SAEs | 120 Participants |
Secondary
Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against any ARI and any LRTD.
Time frame: From Day 15 post first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Any ARI (Single dose) | 4858 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Any ARI (Annual revaccination) | 4731 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Any LRTD (Single dose) | 12450 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Any LRTD (Annual revaccination) | 2308 Participants |
| Placebo Group | Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Any LRTD (Annual revaccination) | 3210 Participants |
| Placebo Group | Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Any ARI (Single dose) | 6096 Participants |
| Placebo Group | Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Any LRTD (Single dose) | 3352 Participants |
| Placebo Group | Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Any ARI (Annual revaccination) | 5914 Participants |
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any ARI in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-1.47, 5.99]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any ARI in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [-0.5, 6.98]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any LRTD in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-1.55, 8.63]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any LRTD in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [1.81, 11.9]Poisson regression method
Secondary
Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Human Metapneumovirus (hMPV) up to the End of Season 1 Following a Single Dose of the RSVPreF3 OA Vaccine
Time frame: From Day 15 post-vaccination up to end of season 1 in the SH [a median of approximately 11.5 months (11.6 months in NH and 9.1 months in SH)]
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Human Metapneumovirus (hMPV) up to the End of Season 1 Following a Single Dose of the RSVPreF3 OA Vaccine | 53 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Human Metapneumovirus (hMPV) up to the End of Season 1 Following a Single Dose of the RSVPreF3 OA Vaccine | 65 Participants |
Comparison: To evaluate vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hMPV-confirmed LRTD in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine up to the end of Season 1.95% CI: [-19.1, 44.33]Poisson regression method
Secondary
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV confirmed A and/or B associated ARI episode. A case of RT-PCR confirmed RSV-associated ARI is characterized by the presence of respiratory symptoms/signs for at least 24 hours OR respiratory symptom/sign + systemic symptom/sign for at least 24 hours with at least one RSV-positive swab detected by RT-PCR.
Time frame: From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV ARI (Single dose) | 131 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV ARI (Annual revaccination) | 103 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV ARI (Single dose) | 428 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV ARI (Annual revaccination) | 385 Participants |
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed ARI in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [40.31, 60.21]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed ARI in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [48.1, 66.96]Poisson regression method
Secondary
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, in the following age categories: greater than or equal to (≥) 65 years of age (YOA), ≥70 YOA and ≥80 YOA.
Time frame: From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), >=80 YOA, | 5 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), >=70 YOA | 20 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), >=65 YOA | 28 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), >=70 YOA | 19 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), >=80 YOA | 5 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), >=65 YOA | 38 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), >=80 YOA | 12 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), >=80 YOA, | 13 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), >=65 YOA | 137 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), >=65 YOA | 156 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), >=70 YOA | 87 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), >=70 YOA | 98 Participants |
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=65YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [40.73, 71.96]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=70YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [44.32, 80.16]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=80YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-93.99, 82.47]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=65YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [49.33, 78.64]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=70YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine at end of season 3.95% CI: [40.49, 79.55]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=80YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine at end of season 3.95% CI: [-108.42, 81.73]Poisson regression method
Secondary
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated LRTD episode by baseline comorbidities of interest divided into 2: cardiorespiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, any chronic respiratory or pulmonary disease, and endocrinometabolic conditions such as diabetes mellitus type 1 or 2, chronic heart failure and advanced liver or renal disease.
Time frame: From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Single dose), No pre-existing comorbidity of interest | 23 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Single dose), At least 1 pre-existing comorbidity of interest | 25 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Single dose), At least 1 pre-existing Cardiorespiratory condition | 17 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Single dose), At least 1 pre-existing Endocrinometabolic condition | 12 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Annual revaccination), No pre-existing comorbidity of interest | 20 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Annual revaccination), At least 1 pre-existing comorbidity of interest | 18 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Annual revaccination), At least 1 pre-existing Cardiorespiratory condition | 11 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Annual revaccination), At least 1 pre-existing Endocrinometabolic condition | 9 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Annual revaccination), At least 1 pre-existing Endocrinometabolic condition | 49 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Single dose), No pre-existing comorbidity of interest | 99 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Annual revaccination), No pre-existing comorbidity of interest | 91 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Single dose), At least 1 pre-existing comorbidity of interest | 116 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Annual revaccination), At least 1 pre-existing Cardiorespiratory condition | 73 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Single dose), At least 1 pre-existing Cardiorespiratory condition | 85 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Annual revaccination), At least 1 pre-existing comorbidity of interest | 101 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities According to Comorbidities of Interest Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Confirmed RSV LRTD (Single dose), At least 1 pre-existing Endocrinometabolic condition | 55 Participants |
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with no pre-existing comorbidity of interest, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [38.62, 76.74]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing comorbidity of interest, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [45.1, 78.14]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing cardiorespiratory condition, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [45.71, 82.33]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing endocrinometabolic condition, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [31.35, 82.48]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with no pre-existing comorbidity of interest, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [41.08, 79.17]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing comorbidity of interest, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [51.92, 83.65]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing cardiorespiratory condition,following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [54.11, 88.54]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing endocrinometabolic condition, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [37.51, 87.05]Poisson regression method
Secondary
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Using Charlson Comorbidity Index Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated LRTD episode by baseline comorbidities using Charlson Comorbidity Index. Low/medium Risk = Participants with co-morbidity score at baseline less than or equal to 3 (Charlson Index); High Risk = Participants with co-morbidity score at baseline greater than 3 (Charlson Index).
Time frame: From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Using Charlson Comorbidity Index Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), Low/Medium risk | 24 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Using Charlson Comorbidity Index Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), High risk | 24 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Using Charlson Comorbidity Index Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), Low/Medium risk | 18 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Using Charlson Comorbidity Index Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), High risk | 20 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Using Charlson Comorbidity Index Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), High risk | 84 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Using Charlson Comorbidity Index Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), Low/Medium risk | 119 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Using Charlson Comorbidity Index Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), Low/Medium risk | 108 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Using Charlson Comorbidity Index Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), High risk | 96 Participants |
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with low/medium risk (Charlson Comorbidity Index), following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [47.54, 79.4]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with high risk (Charlson Comorbidity Index), following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [34.81, 74.98]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with low/medium risk (Charlson Comorbidity Index), following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [54.34, 84.37]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with high risk (Charlson Comorbidity Index), following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [37.17, 78.01]Poisson regression method
Secondary
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and /or B associated LRTD episode according to the case definition, by baseline frailty status of frail, pre-frail and fit. Frail = Participants with a walking speed of less than (\<) 0.4 meters per second (m/s) or who were not able to perform the test; Pre-Frail = Participants with a walking speed between 0.4-0.99 m/s; Fit = Participants with a walking speed of ≥1 m/s.
Time frame: From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), Frail | 1 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), Pre-Frail | 10 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), Frail | 2 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), Pre-Frail | 12 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), Fit | 34 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), Fit | 27 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), Fit | 126 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), Fit | 145 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), Frail | 1 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), Frail | 1 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Annual revaccination), Pre-Frail | 63 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD (Single dose), Pre-Frail | 67 Participants |
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (frail) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-16322.97, 88]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (pre-frail) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [43.89, 85.33]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (fit) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [42.89, 74.08]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (frail) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [-6751.38, 98.91]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (pre-frail) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [49.33, 88.31]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (fit) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [46.1, 77.75]Poisson regression method
Secondary
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by RSV season as follows: VE after each season includes the first occurrence of episodes reported from Day 15 post vaccination at first season, and for the next seasons, excluding analysis of participants who already reported a case in the previous season. The RSV season may be extended based on epidemiology data.
Time frame: From Day 15 post first dose or start of the RSV season to the first occurrence of RSV-confirmed LRTD at each RSV season (assessed approximately over 7 months at each season [Seasons 1 and 2 in SH, Seasons 1, 2 and 3 in NH])
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. Analysis is presented based on the groups at each season (RSVPreF3 group for Season 1, RSV\_1\_dose and RSV\_annual groups for Seasons 2 and 3, Placebo group for Season 1, 2 and 3).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Season 1 | 7 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Season 3 (Single dose) | 60 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Season 3 (Annual revaccination) | 37 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Season 1 | 36 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Season 2 (Single dose) | 98 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Season 2 (Annual revaccination) | 98 Participants |
| RSV_1_dose Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Season 3 (Single dose) | 16 Participants |
| RSV_1_dose Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Season 2 (Single dose) | 19 Participants |
| RSV_annual Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Season 2 (Annual revaccination) | 22 Participants |
| RSV_annual Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Season 3 (Annual revaccination) | 6 Participants |
Comparison: To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 1 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [55.9, 92.73]Poisson regression method
Comparison: To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 2 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [36.44, 77.7]Poisson regression method
Comparison: To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 3 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [7.06, 71.59]Poisson regression method
Comparison: To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 2 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [27.85, 72.98]Poisson regression method
Comparison: To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 3 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [22.35, 88.79]Poisson regression method
Secondary
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by years after vaccination as follows: VE at each year includes the first occurrence of episodes reported from Day 14 post vaccination at first year, and for the next years, excluding analysis of participants who already reported a case in the previous year.
Time frame: From Day 15 post first dose and each revaccination dose up to next dose or end of study (assessed approximately over a year after each vaccination [at Year 1, Year 2 and Year 3])
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. Analysis is presented based on the groups at each season (RSVPreF3 group for Year 1, RSV\_1\_dose and RSV\_annual groups for Years 2 and 3, Placebo group for Years 1, 2 and 3).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Year 1 | 10 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Year 3 (Single dose) | 61 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Year 3 (Annual revaccination) | 38 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Year 1 | 47 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Year 2 (Single dose) | 106 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Year 2 (Annual revaccination) | 106 Participants |
| RSV_1_dose Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Year 3 (Single dose) | 16 Participants |
| RSV_1_dose Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Year 2 (Single dose) | 22 Participants |
| RSV_annual Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Year 3 (Annual revaccination) | 6 Participants |
| RSV_annual Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV LRTD, Year 2 (Annual revaccination) | 22 Participants |
Comparison: To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 1 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [57.62, 90.48]Poisson regression method
Comparison: To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 2 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [34, 75.1]Poisson regression method
Comparison: To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 3 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [8.51, 71.97]Poisson regression method
Comparison: To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 2 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [33.59, 74.94]Poisson regression method
Comparison: To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 3 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [24.64, 89.08]Poisson regression method
Secondary
Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Time frame: From Day 15 post first dose to the first occurrence of RSV LRTD (assessed approximately over 3 years in the NH and 2.5-3 years in SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Season 2 (Single dose) | 32 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Season 3 (NH) (Single dose) | 48 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Season 2 (Annual revaccination) | 32 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Season 3 (NH) (Annual revaccination) | 38 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Season 1 | 10 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Season 3 (NH) (Annual revaccination) | 192 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Season 1 | 47 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Season 2 (Single dose) | 154 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Season 2 (Annual revaccination) | 154 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | Season 3 (NH) (Single dose) | 215 Participants |
Comparison: To evaluate the evolution of efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 1.95% CI: [57.95, 89.26]Regression, Cox
Comparison: To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 2, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [52.47, 77.95]Regression, Cox
Comparison: To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 3, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [46.76, 74.11]Regression, Cox
Comparison: To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 2, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [52.27, 77.86]Regression, Cox
Comparison: To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 3, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [51.71, 78.34]Regression, Cox
Secondary
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine was assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition.
Time frame: From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the NH (assessed approximately over 2 and 3 years in NH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2 administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine | Season 2 (NH) | 30 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine | Season 3 (NH) | 38 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine | Season 2 (NH) | 139 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine | Season 3 (NH) | 192 Participants |
Comparison: To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine followed by 1 annual revaccination before Season 2 in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over three seasons.97.5% CI: [51.82, 79.11]Poisson regression method
Comparison: To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine followed by 1 annual revaccination before Season 2 in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over two seasons.97.5% CI: [48.09, 80]Poisson regression method
Secondary
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
Efficacy of a single dose of the RSVPreF3 OA vaccine was assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition.
Time frame: From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemisphere [NH] (assessed approximately over 2 and 3 years in NH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2 administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following a Single Dose of the RSVPreF3 OA Vaccine | Season 2 (NH) | 30 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following a Single Dose of the RSVPreF3 OA Vaccine | Season 3 (NH) | 48 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following a Single Dose of the RSVPreF3 OA Vaccine | Season 2 (NH) | 139 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following a Single Dose of the RSVPreF3 OA Vaccine | Season 3 (NH) | 215 Participants |
Comparison: To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over three seasons.97.5% CI: [46.74, 74.79]Poisson regression method
Comparison: To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over two seasons.97.5% CI: [48.19, 80.04]Poisson regression method
Secondary
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated severe LRTD episode. Case definition for RSV-confirmed severe LRTD: An RT-PCR confirmed case of RSV-associated severe LRTD is characterized by presence of lower respiratory signs or an LRTD episode assessed as severe by the investigator (Severe LRTD case definition 1) or presence of an LRTD with need for oxygen supplementation or need for positive airway pressure therapy or need for other types of mechanical ventilation (Severe LRTD case definition 2) and with at least one RSV positive swab detected by RT-PCR.
Time frame: From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV severe LRTD (Single dose), Definition 1: Clinical symptomology | 15 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV severe LRTD (Annual revaccination), Any | 9 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV severe LRTD (Single dose), Any | 15 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV severe LRTD (Annual revaccination), Definition 1: Clinical symptomology | 9 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV severe LRTD (Single dose), Definition 2: Supportive therapy | 2 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV severe LRTD (Annual revaccination), Definition 2: Supportive therapy | 0 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV severe LRTD (Single dose), Definition 2: Supportive therapy | 7 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV severe LRTD (Single dose), Any | 75 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV severe LRTD (Single dose), Definition 1: Clinical symptomology | 75 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV severe LRTD (Annual revaccination), Definition 2: Supportive therapy | 6 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV severe LRTD (Annual revaccination), Any | 67 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses | RT-PCR-confirmed RSV severe LRTD (Annual revaccination), Definition 1: Clinical symptomology | 67 Participants |
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to any case definition, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [42.43, 82.68]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 1, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [42.43, 82.68]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to the case definition 2, following a single dose of the RSVPreF3 OA investigational vaccine.95% CI: [-119.6, 95.93]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to any case definition, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [57.05, 90.75]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 1, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [57.05, 90.75]Poisson regression method
Comparison: To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 2, following annual revaccination of the RSVPreF3 OA investigational vaccine.95% CI: [20.27, 100]Poisson regression method
Secondary
Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
Efficacy of a single dose of the RSVPreF3 OA vaccine was assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition.
Time frame: From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH, and 2.5-3 years in SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2 administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine | RT-PCR-confirmed RSV-A LRTD | 14 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine | RT-PCR-confirmed RSV-B LRTD | 34 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine | RT-PCR-confirmed RSV-A LRTD | 80 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine | RT-PCR-confirmed RSV-B LRTD | 135 Participants |
Comparison: To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype A in adults ≥ 60 YOA over 3 seasons.97.5% CI: [42.18, 85.72]Poisson regression method
Comparison: To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype B in adults ≥ 60 YOA over 3 seasons.97.5% CI: [35.9, 74.11]Poisson regression method
Secondary
Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following 1 Annual Revaccination Dose
Efficacy of a single dose and 1 annual revaccination dose of the RSVPreF3 OA vaccine was assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition.
Time frame: From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH, and 2.5-3 years in SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following 1 Annual Revaccination Dose | RT-PCR-confirmed RSV-A LRTD | 17 Participants |
| RSVPreF3 Group | Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following 1 Annual Revaccination Dose | RT-PCR-confirmed RSV-B LRTD | 21 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following 1 Annual Revaccination Dose | RT-PCR-confirmed RSV-A LRTD | 65 Participants |
| Placebo Group | Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following 1 Annual Revaccination Dose | RT-PCR-confirmed RSV-B LRTD | 127 Participants |
Comparison: To demonstrate the vaccine efficacy of a single dose and 1 annual revaccination before Season 2 of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype A in adults ≥ 60 YOA over 3 seasons.97.5% CI: [16.52, 77.52]Poisson regression method
Comparison: To demonstrate the vaccine efficacy of a single dose and 1 annual revaccination before Season 2 of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype B in adults ≥ 60 YOA over 3 seasons.97.5% CI: [55.1, 85.4]Poisson regression method
Secondary
Number of Participants With Potential Immune Mediated Diseases (pIMDs)
pIMDs aredefined as a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any= occurrence of any pIMD regardless of intensity grade or relation to the study vaccination.
Time frame: From the day of the vaccination up to 6 months after each vaccination (first vaccination: at Day 1, second vaccination: at pre-season 2 and the third vaccination: at pre-season 3 -only applicable for participants in NH])
Population: Analysis is performed on the Exposed Set, which included all participants that received at least the first vaccination. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With Potential Immune Mediated Diseases (pIMDs) | Any pIMDs (post Dose 2) | 39 Participants |
| RSVPreF3 Group | Number of Participants With Potential Immune Mediated Diseases (pIMDs) | Any pIMDs (post Dose 1) | 39 Participants |
| RSVPreF3 Group | Number of Participants With Potential Immune Mediated Diseases (pIMDs) | Any pIMDs (post Dose 3) | 13 Participants |
| Placebo Group | Number of Participants With Potential Immune Mediated Diseases (pIMDs) | Any pIMDs (post Dose 2) | 19 Participants |
| Placebo Group | Number of Participants With Potential Immune Mediated Diseases (pIMDs) | Any pIMDs (post Dose 1) | 27 Participants |
| Placebo Group | Number of Participants With Potential Immune Mediated Diseases (pIMDs) | Any pIMDs (post Dose 3) | 8 Participants |
| RSV_1_dose Group | Number of Participants With Potential Immune Mediated Diseases (pIMDs) | Any pIMDs (post Dose 1) | 19 Participants |
| RSV_1_dose Group | Number of Participants With Potential Immune Mediated Diseases (pIMDs) | Any pIMDs (post Dose 3) | 10 Participants |
| RSV_1_dose Group | Number of Participants With Potential Immune Mediated Diseases (pIMDs) | Any pIMDs (post Dose 2) | 14 Participants |
Secondary
Number of Participants With Related pIMDs
Related pIMD = pIMD assessed by the investigator as related to the study vaccination.
Time frame: From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Population: Analysis was performed on the Exposed Set. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSVPreF3 Group | Number of Participants With Related pIMDs | 9 Participants |
| Placebo Group | Number of Participants With Related pIMDs | 7 Participants |
| RSV_1_dose Group | Number of Participants With Related pIMDs | 5 Participants |
Secondary
Number of Participants With Related SAEs
Related SAEs that occur throughout the study are assessed. Related SAEs= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator.
Time frame: From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH)
Population: Analysis was performed on the Exposed Set. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSVPreF3 Group | Number of Participants With Related SAEs | 12 Participants |
| Placebo Group | Number of Participants With Related SAEs | 8 Participants |
| RSV_1_dose Group | Number of Participants With Related SAEs | 12 Participants |
Secondary
Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity
RSV A and/or B ARI and LRTD episodes were assessed as mild, moderate or severe by the investigator after the single dose and after annual revaccination. Mild = an ARI/LRTD episode which is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. Moderate = an ARI/LRTD episode which is sufficiently discomforting to interfere with normal everyday activities. Severe = an ARI/LRTD episode which prevents normal, everyday activities.
Time frame: Assessed during the study period (approximately 3 years for NH and 2.5-3 years for SH)
Population: Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. For single dose evaluation, participants from the RSV\_annual group who received RSVPreF3 OA investigational vaccine at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2. For annual dose evaluation, participants from the RSV\_1\_dose group who received Placebo at Dose 2 contributed to Season 1 data only and were censored starting from Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity | Mild (Annual revaccination) | 15 Participants |
| RSVPreF3 Group | Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity | Mild (Single dose) | 16 Participants |
| RSVPreF3 Group | Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity | Moderate (Annual revaccination) | 23 Participants |
| RSVPreF3 Group | Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity | Severe (Single dose) | 3 Participants |
| RSVPreF3 Group | Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity | Severe (Annual revaccination) | 0 Participants |
| RSVPreF3 Group | Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity | Moderate (Single dose) | 29 Participants |
| Placebo Group | Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity | Severe (Annual revaccination) | 24 Participants |
| Placebo Group | Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity | Mild (Single dose) | 49 Participants |
| Placebo Group | Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity | Moderate (Single dose) | 138 Participants |
| Placebo Group | Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity | Severe (Single dose) | 28 Participants |
| Placebo Group | Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity | Mild (Annual revaccination) | 48 Participants |
| Placebo Group | Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity | Moderate (Annual revaccination) | 120 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to study vaccination.
Time frame: From the day of the vaccination up to 6 months after each vaccination (first vaccination: at Day 1, second vaccination: at pre-season 2 and the third vaccination: at pre-season 3 -only applicable for participants in NH])
Population: Analysis is performed on the Exposed Set, which included all participants that received at least the first vaccination. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSVPreF3 Group | Number of Participants With Serious Adverse Events (SAEs) | Any SAE (post Dose 2) | 497 Participants |
| RSVPreF3 Group | Number of Participants With Serious Adverse Events (SAEs) | Any SAE (post Dose 1) | 541 Participants |
| RSVPreF3 Group | Number of Participants With Serious Adverse Events (SAEs) | Any SAE (post Dose 3) | 179 Participants |
| Placebo Group | Number of Participants With Serious Adverse Events (SAEs) | Any SAE (post Dose 2) | 239 Participants |
| Placebo Group | Number of Participants With Serious Adverse Events (SAEs) | Any SAE (post Dose 1) | 280 Participants |
| Placebo Group | Number of Participants With Serious Adverse Events (SAEs) | Any SAE (post Dose 3) | 75 Participants |
| RSV_1_dose Group | Number of Participants With Serious Adverse Events (SAEs) | Any SAE (post Dose 1) | 268 Participants |
| RSV_1_dose Group | Number of Participants With Serious Adverse Events (SAEs) | Any SAE (post Dose 3) | 73 Participants |
| RSV_1_dose Group | Number of Participants With Serious Adverse Events (SAEs) | Any SAE (post Dose 2) | 229 Participants |
Secondary
RSV A Neutralizing Antibody Titers
The RSV A neutralizing antibody titers are expressed as geometric mean titers (GMTs).
Time frame: At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH)
Population: Analysis was performed in a subset of participants from the PPSi. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSVPreF3 Group | RSV A Neutralizing Antibody Titers | Pre-Season 2 | 865.8 Titers |
| RSVPreF3 Group | RSV A Neutralizing Antibody Titers | Pre-dose 1 at day 1 | 933.5 Titers |
| RSVPreF3 Group | RSV A Neutralizing Antibody Titers | Pre-Season 3 | 977.9 Titers |
| RSVPreF3 Group | RSV A Neutralizing Antibody Titers | Post-dose 1 at day 31 | 880.8 Titers |
| Placebo Group | RSV A Neutralizing Antibody Titers | Pre-Season 2 | 2535.9 Titers |
| Placebo Group | RSV A Neutralizing Antibody Titers | Post-dose 1 at day 31 | 8915.5 Titers |
| Placebo Group | RSV A Neutralizing Antibody Titers | Pre-dose 1 at day 1 | 899.8 Titers |
| Placebo Group | RSV A Neutralizing Antibody Titers | Pre-Season 3 | 2049.7 Titers |
| RSV_1_dose Group | RSV A Neutralizing Antibody Titers | Post-dose 1 at day 31 | 9652.4 Titers |
| RSV_1_dose Group | RSV A Neutralizing Antibody Titers | Pre-dose 1 at day 1 | 929.3 Titers |
| RSV_1_dose Group | RSV A Neutralizing Antibody Titers | Pre-Season 3 | 2996.1 Titers |
| RSV_1_dose Group | RSV A Neutralizing Antibody Titers | Pre-Season 2 | 2918.4 Titers |
Secondary
RSV B Neutralizing Antibody Titers
RSV B neutralizing antibodies are expressed as GMTs.
Time frame: At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH)
Population: Analysis was performed on PPSi. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSVPreF3 Group | RSV B Neutralizing Antibody Titers | Pre-Season 3 | 946.8 Titers |
| RSVPreF3 Group | RSV B Neutralizing Antibody Titers | Pre-dose 1 at day 1 | 1249.7 Titers |
| RSVPreF3 Group | RSV B Neutralizing Antibody Titers | Post-dose 1 at day 31 | 1262.4 Titers |
| RSVPreF3 Group | RSV B Neutralizing Antibody Titers | Pre-Season 2 | 1229.7 Titers |
| Placebo Group | RSV B Neutralizing Antibody Titers | Pre-Season 2 | 2955.5 Titers |
| Placebo Group | RSV B Neutralizing Antibody Titers | Pre-dose 1 at day 1 | 1189.9 Titers |
| Placebo Group | RSV B Neutralizing Antibody Titers | Pre-Season 3 | 2054.5 Titers |
| Placebo Group | RSV B Neutralizing Antibody Titers | Post-dose 1 at day 31 | 9928.9 Titers |
| RSV_1_dose Group | RSV B Neutralizing Antibody Titers | Pre-Season 3 | 2515.3 Titers |
| RSV_1_dose Group | RSV B Neutralizing Antibody Titers | Post-dose 1 at day 31 | 10253.4 Titers |
| RSV_1_dose Group | RSV B Neutralizing Antibody Titers | Pre-Season 2 | 2979.2 Titers |
| RSV_1_dose Group | RSV B Neutralizing Antibody Titers | Pre-dose 1 at day 1 | 1187.2 Titers |
Secondary
RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations
The RSVPreF3 IgG antibody concentrations are expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EU/mL).
Time frame: At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH)
Population: Analysis was performed in a subset of participants from the Per Protocol Set for immunogenicity (PPSi), which included participants who received at least the first dose of the study intervention, have post-vaccination immunogenicity data available, and did not meet protocol deviations that lead to exclusion. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSVPreF3 Group | RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations | Pre-dose 1 at day 1 | 7090.2 EU/mL |
| RSVPreF3 Group | RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations | Post-dose 1 at day 31 | 7053.2 EU/mL |
| RSVPreF3 Group | RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations | Pre-Season 2 | 7594.8 EU/mL |
| RSVPreF3 Group | RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations | Pre-Season 3 | 8436.6 EU/mL |
| Placebo Group | RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations | Pre-Season 3 | 21255.0 EU/mL |
| Placebo Group | RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations | Pre-dose 1 at day 1 | 6956.5 EU/mL |
| Placebo Group | RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations | Pre-Season 2 | 24103.6 EU/mL |
| Placebo Group | RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations | Post-dose 1 at day 31 | 89361.9 EU/mL |
| RSV_1_dose Group | RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations | Pre-Season 3 | 28925.3 EU/mL |
| RSV_1_dose Group | RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations | Post-dose 1 at day 31 | 93769.5 EU/mL |
| RSV_1_dose Group | RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations | Pre-Season 2 | 24523.8 EU/mL |
| RSV_1_dose Group | RSVPreF3 Specific Immunoglobulin G(IgG) Antibody Concentrations | Pre-dose 1 at day 1 | 7101.1 EU/mL |