A Study on the Immune Response and Safety of a Vaccine Ag... | NCT05590403 | Trialant
NCT05590403
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Mar 6, 2025Actual
Enrollment
1,544Actual
Phase
Phase 3
Conditions
Respiratory Syncytial Virus Infections
Interventions
RSVPreF3 OA investigational vaccine
Placebo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT05590403
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
219238
Secondary IDs
ID
Type
Description
Link
2022-001981-36
EudraCT Number
Brief Title
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above
Official Title
A Phase 3, Observer-blind, Randomized, Placebo-controlled Study to Evaluate the Non-inferiority of the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults ≥60 Years of Age
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Feb 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 28, 2022Actual
Primary Completion Date
Mar 13, 2023Actual
Completion Date
Feb 12, 2024Actual
First Submitted Date
Oct 18, 2022
First Submission Date that Met QC Criteria
Oct 18, 2022
First Posted Date
Oct 21, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Mar 13, 2024
Results First Submitted that Met QC Criteria
Apr 25, 2024
Results First Posted Date
May 21, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 11, 2025
Last Update Posted Date
Mar 6, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD), versus adults >=60 YOA
Detailed Description
Not provided
Conditions Module
Conditions
Respiratory Syncytial Virus Infections
Keywords
Respiratory syncytial virus
Immunogenicity
Safety
Increased risk of respiratory syncytial virus lower respiratory tract disease
Adults aged 50-59 years of age
Older adults 60 years of age and above
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,544Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Adults HA-RSV Group
Experimental
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-Lower respiratory tract disease (RSV-LRTD), aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Biological: RSVPreF3 OA investigational vaccine
Adults HA-Placebo Group
Placebo Comparator
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
Drug: Placebo
Adults AIR-RSV Group
Experimental
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Biological: RSVPreF3 OA investigational vaccine
Adults AIR-Placebo Group
Placebo Comparator
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
Drug: Placebo
OA-RSV Group
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RSVPreF3 OA investigational vaccine
Biological
One dose administered intramuscularly at Day 1.
Adults AIR-RSV Group
Adults HA-RSV Group
OA-RSV Group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated subjects. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to 4 (>=4).
At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling)
Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol
Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
1. Specific inclusion criteria for all participants in Cohort 1 (Adults HA-RSV Group, Adults HA-Placebo Group, Adults AIR-RSV Group & Adults AIR-Placebo Group)
A male or female participant 50-59 YOA at the time of the study intervention administration.
Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause.
Female participants of childbearing potential may be enrolled in the study, if the participant:
has practiced adequate contraception from 1 month prior to study intervention administration until study end for this study, and
has a negative pregnancy test on the day of study intervention administration.
Specific inclusion criteria for participants in the Adults-HA Sub-cohort
Healthy participants as established by medical history and clinical examination before entering into the study.
Participants with chronic stable medical conditions with or without specific treatment, such as hypertension, hypercholesterolemia, or hypothyroidism, and who are not at increased risk for RSV-LRTD , are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).
Specific inclusion criteria for participants in the Adults-AIR Sub cohort
Participants should be diagnosed with at least 1 of the following medical conditions and have a stable condition (no changes in the treatment or disease severity in the past 3 months):
Chronic pulmonary disease resulting in activity restricting symptoms or use of long-term medication
Chronic cardiovascular disease
Diabetes mellitus: types 1 and 2
Other diseases at increased risk for RSV-LRTD disease
Chronic kidney disease
Chronic liver disease 2. Specific inclusion criteria for Cohort 2 (OA-RSV Group)
A male or female participant ≥60 YOA at the time of the study intervention administration.
Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).
Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
Exclusion Criteria:
Medical conditions
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
Hypersensitivity to latex.
Unstable chronic illness.
Any history of dementia or any medical condition that moderately or severely impairs cognition.
Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol. Study participants may decide to assign a caregiver to help them complete the study procedures.
Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Prior/Concomitant therapy
Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 4, Month 12).
Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated and subunit influenza vaccines or COVID-19 vaccines (fully licensed or with EUA) which can be administered up to 14 days before or from 14 days after the study intervention administration.
Note: In case an emergency mass vaccination for an unforeseen public health threat is recommended and/or organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
Previous vaccination with an RSV vaccine, including investigational RSV vaccines.
Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune modifying treatments or planned administration at any time up to the end of the study.
Up to 3 months prior to the study intervention administration:
For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
Administration of immunoglobulins and/or any blood products or plasma derivatives.
Up to 6 months prior to study intervention administration: long-acting immune modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
Prior/Concurrent clinical study experience
• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or invasive medical device).
Other exclusions Other exclusions for all participants
History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
Bedridden participants.
Planned move during the study period that will prohibit participating in the study until study end.
Participation of any study personnel or their immediate dependents, family, or household members.
Other exclusions for Cohort 1
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Ferguson M, Schwarz TF, Nunez SA, Rodriguez-Garcia J, Mital M, Zala C, Pek B, Schmitt B, Toursarkissian N, Ochoa Mazarro D, Grosskopf J, Voors-Pette C, Mehta H, Amare Hailemariam H, Gerard C, Damaso S, David MP, Descamps D, Hill J, Vandermeulen C, Hulstrom V. Immune persistence and safety of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in adults 50-59 years of age, including at-increased-risk adults: A randomized controlled trial. Hum Vaccin Immunother. 2025 Dec;21(1):2579335. doi: 10.1080/21645515.2025.2579335. Epub 2025 Nov 5.
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Out of 1544 participants enrolled in this study, 1534 participants received at least one study intervention, from which 1 participant in OA-RSV group received placebo instead of RSVPreF3 OA vaccine and was excluded from the group. Therefore, the Exposed set included 1533 participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-Lower respiratory tract disease (RSV-LRTD), aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 30, 2023
Mar 13, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Canada
Germany
Japan
Netherlands
Poland
Spain
United States
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
Observer-blind for Cohort 1 (Day1-Day 31) and single-blind afterwards and open-label for Cohort 2
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Biological: RSVPreF3 OA investigational vaccine
Placebo
Drug
One dose administered intramuscularly at Day 1.
Adults AIR-Placebo Group
Adults HA-Placebo Group
At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness)
Assessed solicited systemic events were arthralgia, fatigue, headache, myalgia and fever [temperature equal to or above (>=) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs)
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
During the 30-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting Any Serious Adverse Events (SAEs) Within 6 Months of Vaccination
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting Any Onset Potential Immune Mediated Diseases (pIMDs) Within 6 Months of Vaccination
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting SAEs Related to Study Intervention Administration Within 12 Months of Vaccination
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting pIMDs Related to Study Intervention Administration Within 12 Months of Vaccination
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
Percentage of Participants Reporting Any Fatal SAEs
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
At 6 months and at 12 months after study intervention administration
RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
At 6 months and at 12 months after study intervention administration
Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention
Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention
Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
At 6 months and at 12 months after study intervention administration
Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention
Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12
Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
At 6 months and at 12 months after study intervention administration
Derived
Ferguson M, Schwarz TF, Nunez SA, Rodriguez-Garcia J, Mital M, Zala C, Schmitt B, Toursarkissian N, Mazarro DO, Grosskopf J, Voors-Pette C, Mehta H, Hailemariam HA, de Heusch M, Salaun B, Damaso S, David MP, Descamps D, Hill J, Vandermeulen C, Hulstrom V; RSV OA=ADJ-018 Study Group. Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to >/=60 Years of Age. Clin Infect Dis. 2024 Oct 15;79(4):1074-1084. doi: 10.1093/cid/ciae364.
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
FG002
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
FG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
FG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
FG000383 subjects
FG001192 subjects
FG002386 subjects
FG003191 subjects
FG004381 subjects
COMPLETED
FG000363 subjects
FG001184 subjects
FG002369 subjects
FG003180 subjects
FG004369 subjects
NOT COMPLETED
FG00020 subjects
FG0018 subjects
FG00217 subjects
FG00311 subjects
FG00412 subjects
Type
Comment
Reasons
Lost to Follow-up
FG00013 subjects
FG0011 subjects
FG0027 subjects
FG0033 subjects
FG0044 subjects
Consent withdrawal, not due to a (S)AE
FG0004 subjects
FG0016 subjects
FG0024 subjects
FG0032 subjects
FG004
Other
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
Migrated / moved from the study area
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0033 subjects
FG004
Adverse event requiring expedited reporting
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0031 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
BG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
BG002
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
BG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
BG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000383
BG001192
BG002386
BG003191
BG004381
BG0051533
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
YEARS
Title
Denominators
Categories
Title
Measurements
BG00054.8± 2.8
BG00154.7± 2.8
BG00255.3± 2.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000221
BG001119
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00048
BG00123
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated subjects. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Analysis was performed on the per protocol set (PPS) for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-A immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG000326
OG001343
Title
Denominators
Categories
Title
Measurements
OG0007906.0(7178.1 to 8707.7)
OG0017518.9(6843.2 to 8261.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.
GMT Ratio
0.95
2-Sided
95
0.83
1.09
The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-HA-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate
Non-Inferiority
Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is less than (<) 1.5 at 1 month post RSVPreF3 OA vaccine administration.
Primary
RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to 4 (>=4).
Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-A at pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Primary
RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-B immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Primary
RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-B at pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Primary
RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Analysis was performed on the per protocol set (PPS) for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-A immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
ID
Title
Description
OG000
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
OA-RSV Group
Primary
RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-A at pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
ID
Title
Description
OG000
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Primary
RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-B immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
ID
Title
Description
OG000
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Primary
RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-B at pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
ID
Title
Description
OG000
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Secondary
Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling)
Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
Analysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for solicited administration site events analysis at the assessed timeframe.
Posted
Number
95% Confidence Interval
Percentage of participants
During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG002
Adults AIR-RSV Group
Secondary
Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness)
Assessed solicited systemic events were arthralgia, fatigue, headache, myalgia and fever [temperature equal to or above (>=) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
Analysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for solicited systemic events analysis at the assessed timeframe.
Posted
Number
95% Confidence Interval
Percentage of participants
During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG002
Adults AIR-RSV Group
Secondary
Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs)
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Analysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for assessed timeframe and unsolicited events analysis.
Posted
Number
95% Confidence Interval
Percentage of participants
During the 30-day follow up period after vaccination (vaccine or placebo administered on Day 1)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG002
Adults AIR-RSV Group
Secondary
Percentage of Participants Reporting Any Serious Adverse Events (SAEs) Within 6 Months of Vaccination
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG002
Adults AIR-RSV Group
Secondary
Percentage of Participants Reporting Any Onset Potential Immune Mediated Diseases (pIMDs) Within 6 Months of Vaccination
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG002
Adults AIR-RSV Group
Secondary
Percentage of Participants Reporting SAEs Related to Study Intervention Administration Within 12 Months of Vaccination
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG002
Secondary
Percentage of Participants Reporting pIMDs Related to Study Intervention Administration Within 12 Months of Vaccination
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG002
Adults AIR-RSV Group
Secondary
Percentage of Participants Reporting Any Fatal SAEs
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG002
Adults AIR-RSV Group
Secondary
RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for the assessed analysis, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only those participants with data available at the time of the analysis were reported in this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titer
At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
Secondary
RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for the assessed analysis, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only those participants with data available at the time of the analysis were reported in this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 6 months and at 12 months after study intervention administration
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
Secondary
RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for the assessed analysis, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only those participants with data available at the time of the analysis were reported in this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titer
At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
Secondary
RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups.
Analysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for the assessed analysis, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only those participants with data available at the time of the analysis were reported in this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 6 months and at 12 months after study intervention administration
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
Secondary
Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention
Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Analysis was performed on Cell-Mediated immune (CMI) sub-cohort of the PPS,which included all eligible participants who received the study intervention as per protocol,had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD4+T cells, complied with blood draw intervals,without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.Only the participants with data available at the time of the analysis were reported
Posted
Geometric Mean
Standard Deviation
CD4+ T cells/million cells
At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
Secondary
Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention
Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Analysis was performed on CMI sub-cohort of the PPS, which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD4+ T cells, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only the participants with data available at the time of the analysis were reported.
Posted
Geometric Mean
Standard Deviation
CD4+ T cells/million cells
At 6 months and at 12 months after study intervention administration
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
Secondary
Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention
Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Analysis was performed on CMI sub-cohort of the PPS, which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD8+ T cells, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only the participants with data available at the time of the analysis were reported.
Posted
Geometric Mean
Standard Deviation
CD8+ T cells/million cells
At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
Secondary
Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12
Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Analysis was performed on CMI sub-cohort of the PPS, which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD8+ T cells, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only the participants with data available at the time of the analysis were reported.
Posted
Geometric Mean
Standard Deviation
CD8+ T cells/million cells
At 6 months and at 12 months after study intervention administration
ID
Title
Description
OG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
Time Frame
Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. SAEs and pIMDs were collected from Day 1 up to Month 6 post dose-administration. Related SAEs, related pIMDs and fatal SAEs were collected from Day 1 up to study end (Month 12).
Description
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
0
383
3
383
325
383
EG001
Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
0
192
4
192
76
192
EG002
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
1
386
15
386
318
386
EG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
1
191
4
191
74
191
EG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
0
381
9
381
279
381
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cold type haemolytic anaemia
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG0030 events0 affected191 at risk
EG004
Pericarditis
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Non-alcoholic fatty liver
Hepatobiliary disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Abscess oral
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
COVID-19
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0023 events3 affected386 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Kyphosis postoperative
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Gouty arthritis
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Cerebellar stroke
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Depression
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0022 events2 affected386 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Death
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenitis
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG0030 events0 affected191 at risk
EG0040 events0 affected381 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Palpitations
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0022 events2 affected386 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Cataract
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Ocular retrobulbar haemorrhage
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Vision blurred
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Abdominal wall haematoma
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected383 at risk
EG0011 events1 affected192 at risk
EG0024 events4 affected386 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected383 at risk
EG0010 events0 affected192 at risk
EG0023 events3 affected386 at risk
EG003
Noninfective sialoadenitis
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Poor dental condition
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0011 events1 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0022 events2 affected386 at risk
EG003
Administration site bruise
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Administration site warmth
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Asthenia
General disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Chest pain
General disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Chills
General disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Fatigue
General disorders
MedDRA v27.0
Systematic Assessment
EG000167 events166 affected383 at risk
EG00134 events34 affected192 at risk
EG002136 events136 affected386 at risk
EG003
Influenza like illness
General disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Injection site bruising
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Injection site erythema
General disorders
MedDRA v27.0
Systematic Assessment
EG00040 events40 affected383 at risk
EG0011 events1 affected192 at risk
EG00255 events55 affected386 at risk
EG003
Injection site induration
General disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Injection site pain
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Injection site pruritus
General disorders
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected383 at risk
EG0010 events0 affected192 at risk
EG0023 events3 affected386 at risk
EG003
Injection site swelling
General disorders
MedDRA v27.0
Systematic Assessment
EG00032 events32 affected383 at risk
EG0012 events2 affected192 at risk
EG00243 events43 affected386 at risk
EG003
Peripheral swelling
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Pyrexia
General disorders
MedDRA v27.0
Systematic Assessment
EG00014 events14 affected383 at risk
EG0012 events2 affected192 at risk
EG00211 events11 affected386 at risk
EG003
Hepatic fibrosis
Hepatobiliary disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
COVID-19
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected383 at risk
EG0011 events1 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Ear infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0002 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Influenza
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Laryngitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0005 events5 affected383 at risk
EG0013 events3 affected192 at risk
EG0027 events7 affected386 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Otitis media
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Rhinitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0023 events3 affected386 at risk
EG003
Suspected COVID-19
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Tooth infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected383 at risk
EG0010 events0 affected192 at risk
EG0023 events3 affected386 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Viral infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0002 events1 affected383 at risk
EG0012 events2 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Immunisation reaction
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Blood pressure increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Helicobacter test positive
Investigations
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Hyperphagia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Impaired fasting glucose
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0022 events2 affected386 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG000102 events101 affected383 at risk
EG00112 events12 affected192 at risk
EG00281 events80 affected386 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0004 events4 affected383 at risk
EG0011 events1 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG000150 events149 affected383 at risk
EG00113 events12 affected192 at risk
EG002123 events123 affected386 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Carotid arteriosclerosis
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0002 events1 affected383 at risk
EG0011 events1 affected192 at risk
EG0022 events2 affected386 at risk
EG003
Headache
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG000139 events137 affected383 at risk
EG00135 events34 affected192 at risk
EG002106 events106 affected386 at risk
EG003
Migraine
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Sciatica
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0022 events2 affected386 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected383 at risk
EG0010 events0 affected192 at risk
EG0022 events2 affected386 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0003 events3 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Eczema nummular
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0011 events1 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Hypertension
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Administration site pain
General disorders
MedDRA v27.0
Systematic Assessment
EG000289 events289 affected383 at risk
EG00120 events20 affected192 at risk
EG002285 events285 affected386 at risk
EG003
Administration site erythema
General disorders
MedDRA v27.0
Systematic Assessment
EG00040 events40 affected383 at risk
EG0011 events1 affected192 at risk
EG00255 events55 affected386 at risk
EG003
Administration site swelling
General disorders
MedDRA v27.0
Systematic Assessment
EG00032 events32 affected383 at risk
EG0010 events0 affected192 at risk
EG0023 events3 affected386 at risk
EG003
Tendon pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Cervicobrachial syndrome
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Hordeolum
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected383 at risk
EG0010 events0 affected192 at risk
EG0020 events0 affected386 at risk
EG003
Candida infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected383 at risk
EG0010 events0 affected192 at risk
EG0021 events1 affected386 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.
Difference in percentage
-2.65
2-Sided
95
-8.54
3.28
The comparison is done using the difference of SRR (OA-RSV -Adults-HA-RSV)
Non-Inferiority
The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is <10%, at 1 month post RSVPreF3 OA vaccine administration.
Units
Counts
Participants
OG000326
OG001342
Title
Denominators
Categories
Title
Measurements
OG0009024.8(8240.8 to 9883.3)
OG0018070.3(7385.2 to 8819.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.
GMT Ratio
0.89
2-Sided
95
0.79
1.02
The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-HA-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate
Non-Inferiority
Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is <1.5 at 1 month post RSVPreF3 OA vaccine administration.
Units
Counts
Participants
OG000255
OG001254
Title
Denominators
Categories
Title
Measurements
OG00078.2(73.3 to 82.6)
OG00174.3(69.3 to 78.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.
Difference in percentage
-3.95
2-Sided
95
-10.39
2.53
The comparison is done using the difference of SRR (OA-RSV -Adults-HA-RSV)
Non-Inferiority
The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is <10%, at 1 month post RSVPreF3 OA vaccine administration.
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG000342
OG001343
Title
Denominators
Categories
Title
Measurements
OG0008925.1(8117.9 to 9812.6)
OG0017460.7(6786.8 to 8201.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.
GMT Ratio
0.84
2-Sided
95
0.73
0.96
The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-AIR-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate
Non-Inferiority
Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is <1.5 at 1 month post RSVPreF3 OA vaccine administration.
Units
Counts
Participants
OG000297
OG001275
Title
Denominators
Categories
Title
Measurements
OG00086.8(82.8 to 90.2)
OG00180.2(75.6 to 84.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.
Difference in percentage
-6.67
2-Sided
95
-12.26
-1.12
The comparison is done using the difference of SRR (OA-RSV -Adults-AIR-RSV)
Non-Inferiority
The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is <10%, at 1 month post RSVPreF3 OA vaccine administration.
Units
Counts
Participants
OG000342
OG001342
Title
Denominators
Categories
Title
Measurements
OG00010048.6(9218.4 to 10953.5)
OG0018073.4(7406.4 to 8800.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.
GMT Ratio
0.80
2-Sided
95
0.71
0.91
The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-AIR-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate
Non-Inferiority
Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is <1.5 at 1 month post RSVPreF3 OA vaccine administration.
Units
Counts
Participants
OG000279
OG001254
Title
Denominators
Categories
Title
Measurements
OG00081.6(77.1 to 85.5)
OG00174.3(69.3 to 78.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.
Difference in percentage
-7.31
2-Sided
95
-13.52
-1.09
The comparison is done using the difference of SRR (OA-RSV -Adults-AIR-RSV)
Non-Inferiority
The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is <10%, at 1 month post RSVPreF3 OA vaccine administration.
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG000377
OG001191
OG002379
OG003189
OG004379
Title
Denominators
Categories
Erythema
Title
Measurements
OG00011.9(8.8 to 15.6)
OG0010.5(0.0 to 2.9)
OG00214.5(11.1 to 18.5)
OG0030.5(0.0 to 2.9)
OG00412.1(9.0 to 15.9)
Pain
Title
Measurements
OG00076.7(72.1 to 80.8)
OG00110.5(6.5 to 15.7)
OG00275.2(70.5 to 79.5)
OG003
Swelling
Title
Measurements
OG0009.3(6.6 to 12.7)
OG0011.0(0.1 to 3.7)
OG00211.6(8.6 to 15.3)
OG003
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG000377
OG001191
OG002379
OG003190
OG004379
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG00026.0(21.6 to 30.7)
OG0015.8(2.9 to 10.1)
OG00220.8(16.9 to 25.3)
OG00310.0(6.1 to 15.2)
OG00412.9(9.7 to 16.7)
Fatigue
Title
Measurements
OG00044.0(39.0 to 49.2)
OG00117.3(12.2 to 23.4)
OG00236.1(31.3 to 41.2)
OG003
Headache
Title
Measurements
OG00035.8(31.0 to 40.9)
OG00116.8(11.8 to 22.8)
OG00227.7(23.3 to 32.5)
OG003
Myalgia
Title
Measurements
OG00039.3(34.3 to 44.4)
OG0015.8(2.9 to 10.1)
OG00232.5(27.8 to 37.4)
OG003
Fever
Title
Measurements
OG0003.7(2.0 to 6.2)
OG0011.0(0.1 to 3.7)
OG0022.6(1.3 to 4.8)
OG003
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG000383
OG001192
OG002386
OG003191
OG004381
Title
Denominators
Categories
Title
Measurements
OG00013.6(10.3 to 17.4)
OG00113.5(9.0 to 19.2)
OG00215.3(11.8 to 19.3)
OG00310.5(6.5 to 15.7)
OG00416.3(12.7 to 20.4)
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG000383
OG001192
OG002386
OG003191
OG004381
Title
Denominators
Categories
Title
Measurements
OG0000.8(0.2 to 2.3)
OG0012.1(0.6 to 5.2)
OG0023.9(2.2 to 6.3)
OG0032.1(0.6 to 5.3)
OG0042.4(1.1 to 4.4)
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG000383
OG001192
OG002386
OG003191
OG004381
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 1.0)
OG0010(0 to 1.9)
OG0021.0(0.3 to 2.6)
OG0030.5(0.0 to 2.9)
OG0040.8(0.2 to 2.3)
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG000383
OG001192
OG002386
OG003191
OG004381
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 1.0)
OG0010(0 to 1.9)
OG0020(0 to 1.0)
OG0030(0.0 to 1.9)
OG0040.3(0.0 to 1.5)
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG000383
OG001192
OG002386
OG003191
OG004381
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 1.0)
OG0010(0 to 1.9)
OG0020(0 to 1.0)
OG0030(0.0 to 1.9)
OG0040.3(0.0 to 1.5)
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG000383
OG001192
OG002386
OG003191
OG004381
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 1.0)
OG0010(0 to 1.9)
OG0021.0(0.3 to 2.6)
OG0030.5(0.0 to 2.9)
OG0040(0 to 1.0)
OG002
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG000347
OG001181
OG002364
OG003186
OG004364
Title
Denominators
Categories
Day 1
ParticipantsOG000347
ParticipantsOG001181
ParticipantsOG002364
ParticipantsOG003186
ParticipantsOG004364
Title
Measurements
OG000768.8(704.7 to 838.9)
OG001772.0(677.9 to 879.1)
OG002779.5(725.5 to 837.6)
OG003
Day 31
ParticipantsOG000329
ParticipantsOG001177
ParticipantsOG002344
ParticipantsOG003178
OG002
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG000317
OG001171
OG002345
OG003178
OG004355
Title
Denominators
Categories
Month 6
ParticipantsOG000317
ParticipantsOG001171
ParticipantsOG002345
ParticipantsOG003178
ParticipantsOG004355
Title
Measurements
OG0003850.7(3448.6 to 4299.7)
OG001849.6(748.9 to 963.9)
OG0023980.6(3608.6 to 4391.1)
OG003
Month 12
ParticipantsOG000306
ParticipantsOG001166
ParticipantsOG002327
ParticipantsOG003170
OG002
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG000347
OG001181
OG002364
OG003186
OG004364
Title
Denominators
Categories
Day 1
ParticipantsOG000347
ParticipantsOG001181
ParticipantsOG002364
ParticipantsOG003186
ParticipantsOG004364
Title
Measurements
OG0001091.1(1000.3 to 1190.2)
OG0011197.7(1055.7 to 1358.8)
OG0021141.4(1050.5 to 1240.0)
OG003
Day 31
ParticipantsOG000329
ParticipantsOG001177
ParticipantsOG002344
ParticipantsOG003178
OG002
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG000317
OG001171
OG002345
OG003178
OG004355
Title
Denominators
Categories
Month 6
ParticipantsOG000317
ParticipantsOG001171
ParticipantsOG002345
ParticipantsOG003178
ParticipantsOG004355
Title
Measurements
OG0003880.7(3488.4 to 4317.0)
OG0011003.2(875.5 to 1149.4)
OG0024020.8(3635.9 to 4446.5)
OG003
Month 12
ParticipantsOG000306
ParticipantsOG001166
ParticipantsOG002327
ParticipantsOG003170
OG002
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG00047
OG00128
OG00255
OG00327
OG00426
Title
Denominators
Categories
Day 1
ParticipantsOG00047
ParticipantsOG00128
ParticipantsOG00255
ParticipantsOG00323
ParticipantsOG00426
Title
Measurements
OG000102.7± 0.9
OG001125.6± 0.9
OG002161.5± 0.6
OG003
Day 31
ParticipantsOG00045
ParticipantsOG00127
ParticipantsOG00246
ParticipantsOG00327
OG002
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG00058
OG00136
OG00256
OG00327
OG00431
Title
Denominators
Categories
Month 6
ParticipantsOG00052
ParticipantsOG00128
ParticipantsOG00255
ParticipantsOG00326
ParticipantsOG00428
Title
Measurements
OG000825.6± 0.3
OG001140.5± 0.8
OG002662.9± 0.3
OG003
Month 12
ParticipantsOG00058
ParticipantsOG00136
ParticipantsOG00256
ParticipantsOG00327
OG002
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Units
Counts
Participants
OG00046
OG00128
OG00255
OG00327
OG00426
Title
Denominators
Categories
Day 1
ParticipantsOG00046
ParticipantsOG00128
ParticipantsOG00255
ParticipantsOG00323
ParticipantsOG00426
Title
Measurements
OG00010.1± 1.1
OG0016.0± 0.9
OG00215.5± 1.0
OG003
Day 31
ParticipantsOG00045
ParticipantsOG00127
ParticipantsOG00246
ParticipantsOG00327
OG002
Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
OG003
Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
OG004
OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.