A Study to Describe the Safety and Immunogenicity of a RS... | NCT03529773 | Trialant
NCT03529773
Sponsor
Pfizer
Status
Completed
Last Update Posted
Mar 3, 2022Actual
Enrollment
1,235Actual
Phase
Phase 2
Conditions
Respiratory Tract Infections
Interventions
Formulation A
Formulation B
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03529773
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C3671001
Secondary IDs
ID
Type
Description
Link
RSV FIH
Other Identifier
Alias Study Number
Brief Title
A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults
Official Title
A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY ADULTS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Mar 2022
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
Apr 18, 2018Actual
Primary Completion Date
Nov 20, 2019Actual
Completion Date
Dec 28, 2020Actual
First Submitted Date
Apr 17, 2018
First Submission Date that Met QC Criteria
May 7, 2018
First Posted Date
May 18, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Nov 18, 2020
Results First Submitted that Met QC Criteria
Feb 11, 2021
Results First Posted Date
Mar 4, 2021Actual
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
Mar 1, 2022
Last Update Posted Date
Mar 3, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with seasonal inactivated influenza vaccine (SIIV).
Detailed Description
The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with SIIV. Healthy male and female subjects divided into 2 age groups (18-49 years of age and 50-85 years of age in the sentinel cohort and 18-49 years of age and 65-85 years of age in the expanded cohort) will be enrolled. Age groups will run in parallel. Subjects in the sentinel cohort in each age group will receive one of two RSV vaccine formulations at one of 3 antigen dose levels or placebo. Subjects in the expanded cohort in each age group will receive one of two RSV vaccine formulations at one of 3 antigen dose levels with and without SIIV.
Conditions Module
Conditions
Respiratory Tract Infections
Keywords
Respiratory tract infections, RSV, vaccine
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,235Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Sentinel Arm 1
Experimental
Low dose formulation A
Biological: Formulation A
Sentinel Arm 2
Experimental
Mid dose formulation A
Biological: Formulation A
Sentinel Arm 3
Experimental
High dose formulation A
Biological: Formulation A
Sentinel Arm 4
Experimental
Low dose formulation B
Biological: Formulation B
Sentinel Arm 5
Experimental
Mid dose formulation B
Biological: Formulation B
Sentinel Arm 6
Experimental
High dose formulation B
Biological: Formulation B
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Formulation A
Biological
RSV vaccine
Expanded Arm 10
Expanded Arm 14
Expanded Arm 15
Expanded Arm 16
Expanded Arm 8
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination
Local reactions included pain at injection site, redness and swelling recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: 2.5 to 5.0 cm, moderate: greater than (>) 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
Within 14 days after vaccination
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity.
Within 14 days after vaccination
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
Within 14 days after vaccination 1 on Day 1
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1
Secondary Outcomes
Measure
Description
Time Frame
Sentinel Cohort: Geometric Mean Titers (GMTs) of Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer lower limit of quantitation (LLOQ) values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
Healthy adults who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures.
Male subject who is able to father children and willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product; female subject who is of childbearing potential and at risk for pregnancy and who is willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product; male subject not able to father children; female subject not of childbearing potential.
Sentinel-cohort subjects only: Male and female adults aged 18 to 85 years at the time of enrollment (signing of the ICD).
Expanded-cohort subjects only: Male and female adults aged 18 to 49 years of age or 65 to 85 years at the time of enrollment (signing of the ICD).
Exclusion Criteria:
Sentinel-cohort subjects only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
Sentinel-cohort subjects only: Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit.
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.
Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt throughout the study of nonstudy RSV vaccine.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product(s).
Immunocompromised subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Subjects who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, subjects should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before investigational product administration. Intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Women who are pregnant or breastfeeding.
Expanded-cohort subjects only: Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
Expanded-cohort subjects only: Allergy to egg proteins (egg or egg products) or chicken proteins.
Walsh EE, Falsey AR, Zareba AM, Jiang Q, Gurtman A, Radley D, Gomme E, Cooper D, Jansen KU, Gruber WC, Swanson KA, Schmoele-Thoma B. Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination. J Infect Dis. 2024 Oct 16;230(4):e905-e916. doi: 10.1093/infdis/jiae185.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Total 1446 participants signed the Informed Consent Form (ICF). Out of which 211 participants were screen failures,1235 actually enrolled into the study and assigned to a study treatment. Only 1233 participants were vaccinated.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Sentinel Cohort: Respiratory Syncytial Virus (RSV) Vaccine 60 Microgram (mcg) Age 18-49 Years
Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
FG001
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity.
Within 14 days after vaccination 1 on Day 1
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination
Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Within 14 days after vaccination
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Within 14 days after vaccination
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Within 14 days after vaccination 1 on Day 1
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Within 14 days after vaccination 1 on Day 1
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 1 month after vaccination (up to 35 days)
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 1 month after vaccination (up to 35 days)
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 1 month after vaccination 1 (up to 35 days)
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 1 month after vaccination 1 (up to 35 days)
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Upto 12 Months After Vaccination
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Upto 12 months after vaccination (up to 378 days)
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Upto 12 months after vaccination (upto 378 days)
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Upto 12 months after vaccination 1 (upto 378 days)
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Upto 12 months after vaccination 1 (upto 378 days)
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
Within 1 month after vaccination 2 (upto Day 70)
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
Within 1 month after vaccination 2 (upto Day 70)
Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination
Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years)
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination
Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years)
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 18 to 49 Years)
The HAI titer LLOQ value for each strain was 10. Assay values below LLOQ were set to 0.5* LLOQ for analysis. Titers were expressed in terms of 1/dilution.
Before vaccination and 1 Month after SIIV vaccination
Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 65 to 85 Years)
The HAI titer LLOQ value for each strain was 10. Assay values below LLOQ were set to 0.5* LLOQ for analysis. Titers were expressed in terms of 1/dilution.
Before vaccination and 1 Month after SIIV vaccination
Anaheim
California
92801
United States
Paradigm Clinical Research Centers, Inc.
La Mesa
California
91942
United States
Paradigm Clinical Research Center
Redding
California
96001
United States
Clinical Research of South Florida
Coral Gables
Florida
33134
United States
Clinical Neuroscience Solutions, Inc.
Orlando
Florida
32801
United States
Meridian Clinical Research
Savannah
Georgia
31406
United States
Clinical Research Atlanta
Stockbridge
Georgia
30281
United States
East-West Medical Research Institute
Honolulu
Hawaii
96814
United States
Meridian Clinical Research Dakota Dunes
Sioux City
Iowa
51106
United States
Augusta Family Practice
Augusta
Kansas
67010
United States
Heartland Research Associates, LLC
Augusta
Kansas
67010
United States
Axtell Clinic, P.A.
Newton
Kansas
67114
United States
Heartland Research Associates, LLC
Newton
Kansas
67114
United States
Heartland Research Associates, LLC
Wichita
Kansas
67207
United States
Sundance Clinical Research, LLC
St Louis
Missouri
63141
United States
Meridian Clinical Research, LLC
Norfolk
Nebraska
68701
United States
Quality Clinical Research, Inc.
Omaha
Nebraska
68114
United States
United Medical Associates
Binghamton
New York
13901
United States
Regional Clinical Research, Inc.
Endwell
New York
13760
United States
Rochester Regional Health/Rochester General Hospital
Rochester
New York
14621
United States
University of Rochester Medical Center
Rochester
New York
14642
United States
PMG Research of Charlotte, LLC
Charlotte
North Carolina
28209
United States
PMG Research of Raleigh
Raleigh
North Carolina
27609
United States
PMG Research of Wilmington, LLC
Wilmington
North Carolina
28401
United States
PMG Research of Winston-Salem, LLC
Winston-Salem
North Carolina
27103
United States
Sterling Research Group, Ltd.
Cincinnati
Ohio
45219
United States
Aventiv Research Inc.
Columbus
Ohio
43213
United States
PriMed Clinical Research
Dayton
Ohio
45419
United States
Lynn Health Science Institute
Oklahoma City
Oklahoma
73112
United States
Benchmark Research
Austin
Texas
78705
United States
Texas Health Care, PLLC
Fort Worth
Texas
76104
United States
Ventavia Research Group, LLC
Fort Worth
Texas
76104
United States
Benchmark Research
Fort Worth
Texas
76135
United States
HealthFirst Medical Group
Fort Worth
Texas
76135
United States
Clinical Trials of Texas, LLC
San Antonio
Texas
78229
United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City
Utah
84109
United States
J. Lewis Research, Inc. /Foothill Family Clinic South
Salt Lake City
Utah
84121
United States
J.Lewis Research, Inc. / Jordan River Family Medicine
South Jordan
Utah
84095
United States
Advanced Clinical Research
West Jordan
Utah
84088
United States
Walsh EE, Falsey AR, Scott DA, Gurtman A, Zareba AM, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Radley D, Gomme E, Cooper D, Schmoele-Thoma B. A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. J Infect Dis. 2022 Apr 19;225(8):1357-1366. doi: 10.1093/infdis/jiab612.
Falsey AR, Walsh EE, Scott DA, Gurtman A, Zareba A, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Jiang Q, Gomme E, Cooper D, Schmoele-Thoma B. Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine. J Infect Dis. 2022 Jun 15;225(12):2056-2066. doi: 10.1093/infdis/jiab611.
Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
FG002
Sentinel Cohort: RSV 120 mcg Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
FG003
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
FG004
Sentinel Cohort: RSV 240 mcg Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
FG005
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
FG006
Sentinel Cohort: Placebo Age 18-49 Years
Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
FG007
Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years
Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
FG008
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
FG009
Sentinel Cohort: RSV 120 mcg Age 50-85 Years
Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
FG010
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
FG011
Sentinel Cohort: RSV 240 mcg Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
FG012
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
FG013
Sentinel Cohort: Placebo Age 50-85 Years
Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
FG014
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 milliliter (mL) seasonal inactivated influenza vaccine (SIIV) intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG015
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG016
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG017
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG018
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG019
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG020
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG021
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG022
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
FG023
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
FG024
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
FG025
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
FG026
Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
FG027
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG028
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
FG029
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG030
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG031
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG032
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG033
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG034
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
FG035
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
FG036
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
FG037
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
FG038
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
FG039
Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
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Type
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No longer meets eligibility criteria
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Other
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Screen Failure
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Safety analysis set included all participants in the sentinel and expanded cohorts who received at least 1 dose of the investigational products.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years
Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
BG001
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
BG002
Sentinel Cohort: RSV 120 mcg Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
BG003
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
BG004
Sentinel Cohort: RSV 240 mcg Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
BG005
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
BG006
Sentinel Cohort: Placebo Age 18-49 Years
Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
BG007
Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years
Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
BG008
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
BG009
Sentinel Cohort: RSV 120 mcg Age 50-85 Years
Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
BG010
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
BG011
Sentinel Cohort: RSV 240 mcg Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
BG012
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
BG013
Sentinel Cohort: Placebo Age 50-85 Years
Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
BG014
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG015
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG016
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG017
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG018
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG019
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG020
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG021
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG022
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
BG023
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
BG024
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
BG025
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
BG026
Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
BG027
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG028
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG029
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG030
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG031
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG032
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG033
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG034
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
BG035
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
BG036
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
BG037
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
BG038
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
BG039
Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
BG040
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00112
BG00212
BG00312
BG00412
BG00512
BG00612
BG00712
BG00812
BG00912
BG01012
BG01112
BG01212
BG01312
BG01441
BG01542
BG01641
BG01740
BG01841
BG01941
BG02041
BG02141
BG02241
BG02341
BG02441
BG02541
BG02641
BG02740
BG02841
BG02940
BG03042
BG03140
BG03240
BG03341
BG03441
BG03540
BG03641
BG03742
BG03843
BG03941
BG0401233
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
BG00032.2± 9.5
BG00134.0± 9.0
BG00234.8± 8.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG00110
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination
Local reactions included pain at injection site, redness and swelling recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: 2.5 to 5.0 cm, moderate: greater than (>) 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 14 days after vaccination
ID
Title
Description
OG000
Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years
Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
OG001
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG002
Sentinel Cohort: RSV 120 mcg Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG003
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG004
Sentinel Cohort: RSV 240 mcg Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG005
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG006
Sentinel Cohort: Placebo Age 18-49 Years
Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination
Units
Counts
Participants
OG00012
OG00112
OG00212
OG003
Title
Denominators
Categories
Pain at injection site: mild
Title
Measurements
OG00050.0(21.1 to 78.9)
OG00158.3(27.7 to 84.8)
OG00225.0(5.5 to 57.2)
Primary
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity.
All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 14 days after vaccination
ID
Title
Description
OG000
Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years
Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
OG001
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG002
Sentinel Cohort: RSV 120 mcg Age 50-85 Years
Primary
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 14 days after vaccination 1 on Day 1
ID
Title
Description
OG000
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG001
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
Primary
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity.
All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 14 days after vaccination 1 on Day 1
ID
Title
Description
OG000
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG001
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
Primary
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination
Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 14 days after vaccination
ID
Title
Description
OG000
Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years
Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
OG001
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years
Primary
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 14 days after vaccination
ID
Title
Description
OG000
Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years
Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
OG001
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years
Primary
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 14 days after vaccination 1 on Day 1
ID
Title
Description
OG000
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG001
Primary
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 14 days after vaccination 1 on Day 1
ID
Title
Description
OG000
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG001
Primary
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 1 month after vaccination (up to 35 days)
ID
Title
Description
OG000
Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years
Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
OG001
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG002
Primary
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 1 month after vaccination (up to 35 days)
ID
Title
Description
OG000
Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years
Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
OG001
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG002
Sentinel Cohort: RSV 120 mcg Age 50-85 Years
Primary
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 1 month after vaccination 1 (up to 35 days)
ID
Title
Description
OG000
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG001
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
Primary
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 1 month after vaccination 1 (up to 35 days)
ID
Title
Description
OG000
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG001
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
Primary
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Upto 12 Months After Vaccination
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1.
Posted
Number
95% Confidence Interval
Percentage of participants
Upto 12 months after vaccination (up to 378 days)
ID
Title
Description
OG000
Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years
Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
OG001
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG002
Sentinel Cohort: RSV 120 mcg Age 18-49 Years
Primary
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1.
Posted
Number
95% Confidence Interval
Percentage of participants
Upto 12 months after vaccination (upto 378 days)
ID
Title
Description
OG000
Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years:
Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
OG001
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG002
Sentinel Cohort: RSV 120 mcg Age 50-85 Years
Primary
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.
Posted
Number
95% Confidence Interval
Percentage of participants
Upto 12 months after vaccination 1 (upto 378 days)
ID
Title
Description
OG000
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG001
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1
Primary
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.
Posted
Number
95% Confidence Interval
Percentage of participants
Upto 12 months after vaccination 1 (upto 378 days)
ID
Title
Description
OG000
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG001
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
Primary
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 1 month after vaccination 2 (upto Day 70)
ID
Title
Description
OG000
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG001
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1
OG002
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Primary
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 1 month after vaccination 2 (upto Day 70)
ID
Title
Description
OG000
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG001
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG002
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Secondary
Sentinel Cohort: Geometric Mean Titers (GMTs) of Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer lower limit of quantitation (LLOQ) values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Evaluable immunogenicity population (EIP): participants who were eligible, received all RSV vaccine or placebo to which they were randomized, had blood drawn for assay testing within 27 to 42 days after Visit 1, had at least 1 valid and determinate assay result at 1-month-postvaccination visit and no major protocol violations. Here, "number analyzed" signifies participants evaluable at specific rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination
ID
Title
Description
OG000
Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years
Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
OG001
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
Secondary
Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years)
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
EIP: participants who were eligible, received all RSV vaccine or placebo to which they were randomized, had blood drawn for assay testing within 27 to 42 days after Visit 1, had at least 1 valid and determinate assay result at 1-month-postvaccination visit and no major protocol violations. Here, "number analyzed" signifies participants evaluable at specific rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination
ID
Title
Description
OG000
Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years
Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
OG001
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG002
Secondary
Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
EIP: participants who were eligible, received all RSV vaccine or placebo to which they were randomized, had blood drawn for assay testing within 27 to 42 days after Visit 1, had at least 1 valid and determinate assay result at 1-month-postvaccination visit and no major protocol violations. Here, "number analyzed" signifies participants evaluable at specific rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
ID
Title
Description
OG000
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG001
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
Secondary
Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years)
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
EIP: participants who were eligible, received all RSV vaccine or placebo to which they were randomized, had blood drawn for assay testing within 27 to 42 days after Visit 1, had at least 1 valid and determinate assay result at 1-month-postvaccination visit and no major protocol violations. Here, "number analyzed" signifies participants evaluable at specific rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
ID
Title
Description
OG000
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG001
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
Secondary
Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 18 to 49 Years)
The HAI titer LLOQ value for each strain was 10. Assay values below LLOQ were set to 0.5* LLOQ for analysis. Titers were expressed in terms of 1/dilution.
Evaluable influenza immunogenicity population (EIIP) : participants who were eligible, received all RSV vaccine or placebo to which they were randomized, received influenza vaccine, had blood drawn for assay testing within 27 to 42 days after Visit 1, had at least 1 valid and determinate assay result at 1-month-postvaccination visit and no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
Titers
Before vaccination and 1 Month after SIIV vaccination
ID
Title
Description
OG000
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG001
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
Secondary
Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 65 to 85 Years)
The HAI titer LLOQ value for each strain was 10. Assay values below LLOQ were set to 0.5* LLOQ for analysis. Titers were expressed in terms of 1/dilution.
EIIP : participants who were eligible, received all RSV vaccine or placebo to which they were randomized, received influenza vaccine, had blood drawn for assay testing within 27 to 42 days after Visit 1, had at least 1 valid and determinate assay result at 1-month-postvaccination visit and no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
Titers
Before vaccination and 1 Month after SIIV vaccination
ID
Title
Description
OG000
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG001
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
Time Frame
Local reactions and systemic events collected as Non-SAEs: within 14 days after Vaccination (Vax) 1 and Vax 3 (for revaccination); Other Non-SAEs: Vax 1 up to 1 month after Vax 1, Vax 3 up to 1 month after Vax 3 for revaccination; SAEs: Vax 1 up to 12 months after Vax 1 (approximately up to 378 days), Vax 1 up to 12 months after Vax 3 for revaccination (approximately up to 798 days)
Description
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
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
Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years
Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
0
12
0
12
9
12
EG001
Sentinel Cohort: RSV 120 mcg Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
0
12
0
12
6
12
EG002
Sentinel Cohort: RSV 240 mcg Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
0
12
0
12
7
12
EG003
Sentinel Cohort: Placebo Age 18-49 Years
Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
0
12
0
12
6
12
EG004
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
0
12
0
12
7
12
EG005
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
0
12
0
12
7
12
EG006
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
1
12
2
12
8
12
EG007
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
0
12
0
12
10
12
EG008
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
0
12
0
12
11
12
EG009
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
0
12
0
12
9
12
EG010
Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years
Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.
0
12
0
12
8
12
EG011
Sentinel Cohort: RSV 120 mcg Age 50-85 Years
Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
0
12
0
12
5
12
EG012
Sentinel Cohort: RSV 240 mcg Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
0
12
1
12
5
12
EG013
Sentinel Cohort: Placebo Age 50-85 Years
Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
0
12
0
12
4
12
EG014
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
0
41
1
41
31
41
EG015
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
0
41
0
41
36
41
EG016
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years:
Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
0
41
1
41
33
41
EG017
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
0
41
0
41
35
41
EG018
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
1
41
2
41
35
41
EG019
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
0
41
1
41
35
41
EG020
Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
0
41
2
41
31
41
EG021
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
0
41
7
41
24
41
EG022
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
0
42
8
42
27
42
EG023
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
0
40
2
40
22
40
EG024
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
1
41
2
41
25
41
EG025
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
1
41
5
41
28
41
EG026
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
0
43
3
43
33
43
EG027
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
0
42
0
42
32
42
EG028
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
0
40
1
40
30
40
EG029
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
1
41
2
41
33
41
EG030
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
0
41
2
41
35
41
EG031
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3
0
41
3
41
32
41
EG032
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
0
41
3
41
38
41
EG033
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
0
40
2
40
22
40
EG034
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
0
40
4
40
20
40
EG035
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years:
Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
0
40
4
40
21
40
EG036
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
1
41
7
41
21
41
EG037
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
0
40
5
40
32
40
EG038
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
0
42
4
42
29
42
EG039
Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
0
41
3
41
21
41
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
EG0080 affected12 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected12 at risk
EG0130 affected12 at risk
EG0140 affected41 at risk
EG0150 affected41 at risk
EG0160 affected41 at risk
EG0170 affected41 at risk
EG0180 affected41 at risk
EG0190 affected41 at risk
EG0200 affected41 at risk
EG0210 affected41 at risk
EG0220 affected42 at risk
EG0230 affected40 at risk
EG0241 affected41 at risk
EG0250 affected41 at risk
EG0260 affected43 at risk
EG0270 affected42 at risk
EG0280 affected40 at risk
EG0291 affected41 at risk
EG0300 affected41 at risk
EG0310 affected41 at risk
EG0320 affected41 at risk
EG0330 affected40 at risk
EG0340 affected40 at risk
EG0350 affected40 at risk
EG0360 affected41 at risk
EG0370 affected40 at risk
EG0380 affected42 at risk
EG0391 affected41 at risk
Atrial fibrillation
Cardiac disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Chest pain
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pyrexia
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Abscess limb
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Influenza
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Viral sepsis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Gun shot wound
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Maisonneuve fracture
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Invasive breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Lung carcinoma cell type unspecified stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Oesophageal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Tonsil cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Autonomic failure syndrome
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Brain injury
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Seizure
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Syncope
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Depression suicidal
Psychiatric disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pregnancy of partner
Social circumstances
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hip arthroplasty
Surgical and medical procedures
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Rectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
COVID-19
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
EG0080 affected12 at risk
EG0090 affected12 at risk
EG0100 affected12 at risk
EG0110 affected12 at risk
EG0120 affected12 at risk
EG0130 affected12 at risk
EG0140 affected41 at risk
EG0150 affected41 at risk
EG0160 affected41 at risk
EG0170 affected41 at risk
EG0180 affected41 at risk
EG0190 affected41 at risk
EG0200 affected41 at risk
EG0210 affected41 at risk
EG0220 affected42 at risk
EG0230 affected40 at risk
EG0240 affected41 at risk
EG0250 affected41 at risk
EG0260 affected43 at risk
EG0270 affected42 at risk
EG0280 affected40 at risk
EG0291 affected41 at risk
EG0300 affected41 at risk
EG0310 affected41 at risk
EG0320 affected41 at risk
EG0330 affected40 at risk
EG0340 affected40 at risk
EG0350 affected40 at risk
EG0360 affected41 at risk
EG0370 affected40 at risk
EG0380 affected42 at risk
EG0390 affected41 at risk
Lymphadenitis
Blood and lymphatic system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Chest pain
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Chills
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Fatigue
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Injection site bruising
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Injection site erythema
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Injection site erythema (REDNESS)
General disorders
MedDRA v24.0
Systematic Assessment
11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Injection site pain
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Injection site pain (PAIN AT INJECTION SITE)
General disorders
MedDRA v24.0
Systematic Assessment
11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
EG0006 affected12 at risk
EG0013 affected12 at risk
EG0022 affected11 at risk
EG003
Injection site pruritus
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Injection site swelling
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Injection site swelling (SWELLING)
General disorders
MedDRA v24.0
Systematic Assessment
11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk.
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected11 at risk
EG003
Malaise
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Oedema peripheral
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pyrexia
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pyrexia (FEVER)
General disorders
MedDRA v24.0
Systematic Assessment
11 participants of sentinel cohort:RSV 240 mcg age 18-49 years,40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 years,RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) arms were at risk
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected11 at risk
EG003
Sensation of foreign body
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Diarrhoea (DIARRHEA)
Gastrointestinal disorders
MedDRA v24.0
Systematic Assessment
11 participants(sentinel cohort:RSV 240 mcg age 18-49 years arm),40 participants(expanded cohort:RSV 120 mcg with aluminum hydroxide and placebo and SIIV Age 18-49 Years arm)40 participants for placebo & placebo & SIIV Age 65-85 years were at risk.
EG0001 affected12 at risk
EG0012 affected12 at risk
EG0023 affected11 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Bronchitis viral
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cystitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Ear infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Folliculitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Furuncle
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Infected cyst
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Influenza
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Otitis externa
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Otitis media
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Vestibular neuronitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Viral infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Face injury
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Blood pressure systolic decreased
Investigations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Arthralgia (JOINT PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Systematic Assessment
11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
EG0001 affected12 at risk
EG0012 affected12 at risk
EG0022 affected11 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Myalgia (MUSCLE PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Systematic Assessment
11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
EG0006 affected12 at risk
EG0014 affected12 at risk
EG0022 affected11 at risk
EG003
Neck mass
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Migraine
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Syncope
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Tension headache
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Nephropathy
Renal and urinary disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Galactorrhoea
Reproductive system and breast disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Respiratory symptom
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Rhinalgia
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dermatitis exfoliative
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pityriasis rosea
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Flushing
Vascular disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hypertension
Vascular disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Fatigue (FATIGUE)
General disorders
MedDRA v24.0
Systematic Assessment
11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
EG0005 affected12 at risk
EG0015 affected12 at risk
EG0026 affected11 at risk
EG003
Nausea (NAUSEA)
Gastrointestinal disorders
MedDRA v24.0
Systematic Assessment
11 participants(sentinel cohort)RSV 240 mcg age 18-49 years,40 participants(expanded cohort)RSV 120 mcg with aluminum hydroxide &placebo&SIIV age18-49 Years&40 participants(expanded cohort) placebo & placebo & SIIV Age 65-85 Years arms were at risk.
EG0004 affected12 at risk
EG0012 affected12 at risk
EG0022 affected11 at risk
EG003
Vomiting (VOMITING)
Gastrointestinal disorders
MedDRA v24.0
Systematic Assessment
11 participant of sentinel cohort: RSV 240 mcg age 18-49 years arm, 40 participants of expanded cohort: RSV 120 mcg with Al(OH)3 and placebo age 18-49 years and 40 participants of expanded Cohort: placebo age 65-85 years arms were at risk.
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0022 affected11 at risk
EG003
Headache (HEADACHE)
Nervous system disorders
MedDRA v24.0
Systematic Assessment
11 participants of sentinel cohort: RSV 240 mcg age 18-49 years, 40 participants of expanded cohort (RSV 120 mcg with aluminum hydroxide and placebo age 18-49 Years, RSV 60 mcg with placebo age 65-85 years and placebo age 65-85 years) were at risk.
EG0005 affected12 at risk
EG0013 affected12 at risk
EG0027 affected11 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Sinusitis bacterial
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Eye irritation
Eye disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 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
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG003
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG004
Sentinel Cohort: RSV 240 mcg Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG005
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG006
Sentinel Cohort: Placebo Age 50-85 Years
Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00512
OG00612
Title
Denominators
Categories
Pain at injection site: mild
Title
Measurements
OG00016.7(2.1 to 48.4)
OG00116.7(2.1 to 48.4)
OG0028.3(0.2 to 38.5)
OG00316.7(2.1 to 48.4)
OG0048.3(0.2 to 38.5)
OG0058.3(0.2 to 38.5)
OG0060(0.0 to 26.5)
Pain at injection site: moderate
Title
Measurements
OG0000(0.0 to 26.5)
OG0018.3(0.2 to 38.5)
OG0020(0.0 to 26.5)
OG003
Pain at injection site: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Redness: mild
Title
Measurements
OG00016.7(2.1 to 48.4)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Redness: moderate
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Redness: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Swelling: mild
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Swelling: moderate
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Swelling: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
OG002
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
OG003
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
OG004
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG005
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
OG006
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
OG007
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
OG008
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG009
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG010
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG011
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG012
Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Units
Counts
Participants
OG00041
OG00142
OG00241
OG00340
OG00441
OG00541
OG00641
OG00740
OG00841
OG00941
OG01041
OG01141
OG01241
Title
Denominators
Categories
Pain at injection site: mild
Title
Measurements
OG00034.1(20.1 to 50.6)
OG00131.0(17.6 to 47.1)
OG00241.5(26.3 to 57.9)
OG00332.5(18.6 to 49.1)
OG00436.6(22.1 to 53.1)
OG00543.9(28.5 to 60.3)
OG00648.8(32.9 to 64.9)
OG00755.0(38.5 to 70.7)
OG00824.4(12.4 to 40.3)
OG00934.1(20.1 to 50.6)
OG01051.2(35.1 to 67.1)
OG01148.8(32.9 to 64.9)
OG01214.6(5.6 to 29.2)
Pain at injection site: moderate
Title
Measurements
OG00012.2(4.1 to 26.2)
OG0017.1(1.5 to 19.5)
OG00226.8(14.2 to 42.9)
OG003
Pain at injection site: severe
Title
Measurements
OG0000(0.0 to 8.6)
OG0010(0.0 to 8.4)
OG0020(0.0 to 8.6)
OG003
Redness: mild
Title
Measurements
OG0002.4(0.1 to 12.9)
OG0014.8(0.6 to 16.2)
OG0020(0.0 to 8.6)
OG003
Redness: moderate
Title
Measurements
OG0000(0.0 to 8.6)
OG0012.4(0.1 to 12.6)
OG0020(0.0 to 8.6)
OG003
Redness: severe
Title
Measurements
OG0000(0.0 to 8.6)
OG0010(0.0 to 8.4)
OG0020(0.0 to 8.6)
OG003
Swelling: mild
Title
Measurements
OG0002.4(0.1 to 12.9)
OG0014.8(0.6 to 16.2)
OG0020(0.0 to 8.6)
OG003
Swelling: moderate
Title
Measurements
OG0002.4(0.1 to 12.9)
OG0014.8(0.6 to 16.2)
OG0020(0.0 to 8.6)
OG003
Swelling: severe
Title
Measurements
OG0000(0.0 to 8.6)
OG0010(0.0 to 8.4)
OG0020(0.0 to 8.6)
OG003
OG002
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
OG003
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
OG004
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG005
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
OG006
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
OG007
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
OG008
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG009
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG010
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG011
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG012
Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG00342
OG00440
OG00540
OG00641
OG00741
OG00840
OG00941
OG01042
OG01143
OG01240
Title
Denominators
Categories
Pain at injection site: mild
Title
Measurements
OG00025.0(12.7 to 41.2)
OG00110.0(2.8 to 23.7)
OG00222.5(10.8 to 38.5)
OG00323.8(12.1 to 39.5)
OG00422.5(10.8 to 38.5)
OG00510.0(2.8 to 23.7)
OG00626.8(14.2 to 42.9)
OG00719.5(8.8 to 34.9)
OG00832.5(18.6 to 49.1)
OG00919.5(8.8 to 34.9)
OG01019.0(8.6 to 34.1)
OG01114.0(5.3 to 27.9)
OG0125.0(0.6 to 16.9)
Pain at injection site: moderate
Title
Measurements
OG0002.5(0.1 to 13.2)
OG0010(0.0 to 8.8)
OG0025.0(0.6 to 16.9)
OG003
Pain at injection site: severe
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Redness: mild
Title
Measurements
OG0002.5(0.1 to 13.2)
OG0012.5(0.1 to 13.2)
OG0020(0.0 to 8.8)
OG003
Redness: moderate
Title
Measurements
OG0005.0(0.6 to 16.9)
OG0012.5(0.1 to 13.2)
OG0022.5(0.1 to 13.2)
OG003
Redness: severe
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Swelling: mild
Title
Measurements
OG0007.5(1.6 to 20.4)
OG0015.0(0.6 to 16.9)
OG0020(0.0 to 8.8)
OG003
Swelling: moderate
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Swelling: severe
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG002
Sentinel Cohort: RSV 120 mcg Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG003
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG004
Sentinel Cohort: RSV 240 mcg Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG005
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG006
Sentinel Cohort: Placebo Age 18-49 Years
Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00411
OG00512
OG00612
Title
Denominators
Categories
Fever: >=38.0 degree C
Title
Measurements
OG0000(0.0 to 26.5)
OG0018.3(0.2 to 38.5)
OG0020(0.0 to 26.5)
OG0030(0.0 to 26.5)
OG0040(0.0 to 28.5)
OG0058.3(0.2 to 38.5)
OG0060(0.0 to 26.5)
Fever: mild
Title
Measurements
OG0000(0.0 to 26.5)
OG0018.3(0.2 to 38.5)
OG0020(0.0 to 26.5)
OG003
Fever: moderate
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Fever: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Fever: Grade 4
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Fatigue: mild
Title
Measurements
OG0008.3(0.2 to 38.5)
OG00141.7(15.2 to 72.3)
OG00216.7(2.1 to 48.4)
OG003
Fatigue: moderate
Title
Measurements
OG00025.0(5.5 to 57.2)
OG0018.3(0.2 to 38.5)
OG00225.0(5.5 to 57.2)
OG003
Fatigue: severe
Title
Measurements
OG0008.3(0.2 to 38.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Headache: mild
Title
Measurements
OG00016.7(2.1 to 48.4)
OG00116.7(2.1 to 48.4)
OG0028.3(0.2 to 38.5)
OG003
Headache: moderate
Title
Measurements
OG00025.0(5.5 to 57.2)
OG00125.0(5.5 to 57.2)
OG00216.7(2.1 to 48.4)
OG003
Headache: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Nausea: mild
Title
Measurements
OG0008.3(0.2 to 38.5)
OG0010(0.0 to 26.5)
OG0028.3(0.2 to 38.5)
OG003
Nausea: moderate
Title
Measurements
OG00016.7(2.1 to 48.4)
OG0010(0.0 to 26.5)
OG0028.3(0.2 to 38.5)
OG003
Nausea: severe
Title
Measurements
OG0008.3(0.2 to 38.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Muscle pain: mild
Title
Measurements
OG00050.0(21.1 to 78.9)
OG00125.0(5.5 to 57.2)
OG00225.0(5.5 to 57.2)
OG003
Muscle pain: moderate
Title
Measurements
OG0000(0.0 to 26.5)
OG0018.3(0.2 to 38.5)
OG0028.3(0.2 to 38.5)
OG003
Muscle pain: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Joint pain: mild
Title
Measurements
OG0008.3(0.2 to 38.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Joint pain: moderate
Title
Measurements
OG0000(0.0 to 26.5)
OG0018.3(0.2 to 38.5)
OG00216.7(2.1 to 48.4)
OG003
Joint pain: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Vomiting: mild
Title
Measurements
OG0008.3(0.2 to 38.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Vomiting: moderate
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Vomiting: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Diarrhea: mild
Title
Measurements
OG0000(0.0 to 26.5)
OG00116.7(2.1 to 48.4)
OG00216.7(2.1 to 48.4)
OG003
Diarrhea: moderate
Title
Measurements
OG0008.3(0.2 to 38.5)
OG0018.3(0.2 to 38.5)
OG0020.0(0.0 to 26.5)
OG003
Diarrhea: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG002
Sentinel Cohort: RSV 120 mcg Age 50-85 Years
Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG003
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG004
Sentinel Cohort: RSV 240 mcg Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG005
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG006
Sentinel Cohort: Placebo Age 50-85 Years
Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00512
OG00612
Title
Denominators
Categories
Fever: >=38.0 degree C
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG0030(0.0 to 26.5)
OG0040(0.0 to 26.5)
OG0050(0.0 to 26.5)
OG0060(0.0 to 26.5)
Fever: mild
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Fever: moderate
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Fever: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Fever: Grade 4
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Fatigue: mild
Title
Measurements
OG00041.7(15.2 to 72.3)
OG00116.7(2.1 to 48.4)
OG00233.3(9.9 to 65.1)
OG003
Fatigue: moderate
Title
Measurements
OG0000(0.0 to 26.5)
OG00133.3(9.9 to 65.1)
OG0020(0.0 to 26.5)
OG003
Fatigue: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0018.3(0.2 to 38.5)
OG0020(0.0 to 26.5)
OG003
Headache: mild
Title
Measurements
OG0000(0.0 to 26.5)
OG0018.3(0.2 to 38.5)
OG0028.3(0.2 to 38.5)
OG003
Headache: moderate
Title
Measurements
OG0008.3(0.2 to 38.5)
OG00116.7(2.1 to 48.4)
OG0020(0.0 to 26.5)
OG003
Headache: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Nausea: mild
Title
Measurements
OG00016.7(2.1 to 48.4)
OG0018.3(0.2 to 38.5)
OG00216.7(2.1 to 48.4)
OG003
Nausea: moderate
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Nausea: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Muscle pain: mild
Title
Measurements
OG00033.3(9.9 to 65.1)
OG00133.3(9.9 to 65.1)
OG0028.3(0.2 to 38.5)
OG003
Muscle pain:moderate
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Muscle pain: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Joint pain: mild
Title
Measurements
OG0008.3(0.2 to 38.5)
OG00116.7(2.1 to 48.4)
OG0020(0.0 to 26.5)
OG003
Joint pain: moderate
Title
Measurements
OG0008.3(0.2 to 38.5)
OG00116.7(2.1 to 48.4)
OG0020(0.0 to 26.5)
OG003
Joint pain: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Vomiting: mild
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0028.3(0.2 to 38.5)
OG003
Vomiting: moderate
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Vomiting: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Diarrhea: mild
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG00216.7(2.1 to 48.4)
OG003
Diarrhea: moderate
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Diarrhea: severe
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG002
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG003
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG004
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG005
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG006
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG007
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG008
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG009
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG010
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG011
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG012
Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Units
Counts
Participants
OG00041
OG00142
OG00241
OG00340
OG00441
OG00541
OG00641
OG00740
OG00841
OG00941
OG01041
OG01141
OG01241
Title
Denominators
Categories
Fever: >=38.0 degree C
Title
Measurements
OG0000(0.0 to 8.6)
OG0010(0.0 to 8.4)
OG0022.4(0.1 to 12.9)
OG0032.5(0.1 to 13.2)
OG00412.2(4.1 to 26.2)
OG0054.9(0.6 to 16.5)
OG0060(0.0 to 8.6)
OG0070(0.0 to 8.8)
OG0082.4(0.1 to 12.9)
OG0092.4(0.1 to 12.9)
OG0100(0.0 to 8.6)
OG0112.4(0.1 to 12.9)
OG0120(0.0 to 8.6)
Fever: mild
Title
Measurements
OG0000(0.0 to 8.6)
OG0010(0.0 to 8.4)
OG0020(0.0 to 8.6)
OG003
Fever: moderate
Title
Measurements
OG0000(0.0 to 8.6)
OG0010(0.0 to 8.4)
OG0022.4(0.1 to 12.9)
OG003
Fever: severe
Title
Measurements
OG0000(0.0 to 8.6)
OG0010(0.0 to 8.4)
OG0020(0.0 to 8.6)
OG003
Fever: Grade 4
Title
Measurements
OG0000(0.0 to 8.6)
OG0010(0.0 to 8.4)
OG0020(0.0 to 8.6)
OG003
Fatigue: mild
Title
Measurements
OG00014.6(5.6 to 29.2)
OG00116.7(7.0 to 31.4)
OG00217.1(7.2 to 32.1)
OG003
Fatigue: moderate
Title
Measurements
OG00031.7(18.1 to 48.1)
OG00128.6(15.7 to 44.6)
OG00224.4(12.4 to 40.3)
OG003
Fatigue: severe
Title
Measurements
OG0002.4(0.1 to 12.9)
OG0010(0.0 to 8.4)
OG0020(0.0 to 8.6)
OG003
Headache: mild
Title
Measurements
OG00012.2(4.1 to 26.2)
OG00128.6(15.7 to 44.6)
OG00219.5(8.8 to 34.9)
OG003
Headache: moderate
Title
Measurements
OG00029.3(16.1 to 45.5)
OG00121.4(10.3 to 36.8)
OG00219.5(8.8 to 34.9)
OG003
Headache: severe
Title
Measurements
OG0002.4(0.1 to 12.9)
OG0014.8(0.6 to 16.2)
OG0020(0.0 to 8.6)
OG003
Nausea: mild
Title
Measurements
OG0004.9(0.6 to 16.5)
OG0017.1(1.5 to 19.5)
OG00212.2(4.1 to 26.2)
OG003
Nausea: moderate
Title
Measurements
OG0009.8(2.7 to 23.1)
OG0017.1(1.5 to 19.5)
OG0027.3(1.5 to 19.9)
OG003
Nausea: severe
Title
Measurements
OG0000(0.0 to 8.6)
OG0010(0.0 to 8.4)
OG0020(0.0 to 8.6)
OG003
Muscle pain: mild
Title
Measurements
OG00024.4(12.4 to 40.3)
OG00116.7(7.0 to 31.4)
OG00234.1(20.1 to 50.6)
OG003
Muscle pain: moderate
Title
Measurements
OG00014.6(5.6 to 29.2)
OG00114.3(5.4 to 28.5)
OG00222.0(10.6 to 37.6)
OG003
Muscle pain: severe
Title
Measurements
OG0002.4(0.1 to 12.9)
OG0010(0.0 to 8.4)
OG0020(0.0 to 8.6)
OG003
Joint pain: mild
Title
Measurements
OG00012.2(4.1 to 26.2)
OG0014.8(0.6 to 16.2)
OG00214.6(5.6 to 29.2)
OG003
Joint pain: moderate
Title
Measurements
OG0007.3(1.5 to 19.9)
OG0017.1(1.5 to 19.5)
OG0029.8(2.7 to 23.1)
OG003
Joint pain: severe
Title
Measurements
OG0000(0.0 to 8.6)
OG0010(0.0 to 8.4)
OG0022.4(0.1 to 12.9)
OG003
Vomiting: mild
Title
Measurements
OG0002.4(0.1 to 12.9)
OG0010(0.0 to 8.4)
OG0020(0.0 to 8.6)
OG003
Vomiting: moderate
Title
Measurements
OG0000(0.0 to 8.6)
OG0010(0.0 to 8.4)
OG0022.4(0.1 to 12.9)
OG003
Vomiting: severe
Title
Measurements
OG0000(0.0 to 8.6)
OG0010(0.0 to 8.4)
OG0020(0.0 to 8.6)
OG003
Diarrhea: mild
Title
Measurements
OG0007.3(1.5 to 19.9)
OG00111.9(4.0 to 25.6)
OG00219.5(8.8 to 34.9)
OG003
Diarrhea: moderate
Title
Measurements
OG0007.3(1.5 to 19.9)
OG00111.9(4.0 to 25.6)
OG0024.9(0.6 to 16.5)
OG003
Diarrhea: severe
Title
Measurements
OG0000(0.0 to 8.6)
OG0010(0.0 to 8.4)
OG0020(0.0 to 8.6)
OG003
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG002
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG003
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG004
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG005
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
OG006
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG007
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
OG008
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG009
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG010
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG011
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG012
Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG00342
OG00440
OG00540
OG00641
OG00741
OG00840
OG00941
OG01042
OG01143
OG01240
Title
Denominators
Categories
Fever: >=38.0 degree C
Title
Measurements
OG0000(0.0 to 8.8)
OG0012.5(0.1 to 13.2)
OG0022.5(0.1 to 13.2)
OG0030(0.0 to 8.4)
OG0040(0.0 to 8.8)
OG0050(0.0 to 8.8)
OG0062.4(0.1 to 12.9)
OG0072.4(0.1 to 12.9)
OG0082.5(0.1 to 13.2)
OG0092.4(0.1 to 12.9)
OG0104.8(0.6 to 16.2)
OG0114.7(0.6 to 15.8)
OG0120(0.0 to 8.8)
Fever: mild
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Fever: moderate
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0022.5(0.1 to 13.2)
OG003
Fever: severe
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Fever: Grade 4
Title
Measurements
OG0000(0.0 to 8.8)
OG0012.5(0.1 to 13.2)
OG0020(0.0 to 8.8)
OG003
Fatigue: mild
Title
Measurements
OG0007.5(1.6 to 20.4)
OG00112.5(4.2 to 26.8)
OG00212.5(4.2 to 26.8)
OG003
Fatigue: moderate
Title
Measurements
OG00012.5(4.2 to 26.8)
OG00110.0(2.8 to 23.7)
OG00215.0(5.7 to 29.8)
OG003
Fatigue: severe
Title
Measurements
OG0000(0.0 to 8.8)
OG0012.5(0.1 to 13.2)
OG0020(0.0 to 8.8)
OG003
Headache: mild
Title
Measurements
OG00017.5(7.3 to 32.8)
OG0017.5(1.6 to 20.4)
OG0027.5(1.6 to 20.4)
OG003
Headache: moderate
Title
Measurements
OG0007.5(1.6 to 20.4)
OG0015.0(0.6 to 16.9)
OG0025.0(0.6 to 16.9)
OG003
Headache: severe
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Nausea: mild
Title
Measurements
OG0005.0(0.6 to 16.9)
OG0017.5(1.6 to 20.4)
OG0022.5(0.1 to 13.2)
OG003
Nausea: moderate
Title
Measurements
OG0000(0.0 to 8.8)
OG0012.5(0.1 to 13.2)
OG0020(0.0 to 8.8)
OG003
Nausea: severe
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Muscle pain: mild
Title
Measurements
OG00015.0(5.7 to 29.8)
OG0017.5(1.6 to 20.4)
OG00210.0(2.8 to 23.7)
OG003
Muscle pain: moderate
Title
Measurements
OG0002.5(0.1 to 13.2)
OG0017.5(1.6 to 20.4)
OG0025.0(0.6 to 16.9)
OG003
Muscle pain: severe
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Joint pain: mild
Title
Measurements
OG00012.5(4.2 to 26.8)
OG00110.0(2.8 to 23.7)
OG0025.0(0.6 to 16.9)
OG003
Joint pain: moderate
Title
Measurements
OG0007.5(1.6 to 20.4)
OG0015.0(0.6 to 16.9)
OG0025.0(0.6 to 16.9)
OG003
Joint pain: severe
Title
Measurements
OG0000(0.0 to 8.8)
OG0012.5(0.1 to 13.2)
OG0020(0.0 to 8.8)
OG003
Vomiting: mild
Title
Measurements
OG0000(0.0 to 8.8)
OG0012.5(0.1 to 13.2)
OG0020(0.0 to 8.8)
OG003
Vomiting: moderate
Title
Measurements
OG0000(0.0 to 8.8)
OG0012.5(0.1 to 13.2)
OG0020(0.0 to 8.8)
OG003
Vomiting: severe
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Diarrhea: mild
Title
Measurements
OG0005.0(0.6 to 16.9)
OG00115.0(5.7 to 29.8)
OG00220.0(9.1 to 35.6)
OG003
Diarrhea: moderate
Title
Measurements
OG0002.5(0.1 to 13.2)
OG0012.5(0.1 to 13.2)
OG0022.5(0.1 to 13.2)
OG003
Diarrhea: severe
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Sentinel Cohort: RSV 120 mcg Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG003
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG004
Sentinel Cohort: RSV 240 mcg Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG005
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG006
Sentinel Cohort: Placebo Age 18-49 Years
Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00512
OG00612
Title
Denominators
Categories
Title
Measurements
OG00016.7(2.1 to 48.4)
OG00116.7(2.1 to 48.4)
OG0020(0.0 to 26.5)
OG0030(0.0 to 26.5)
OG0048.3(0.2 to 38.5)
OG00516.7(2.1 to 48.4)
OG0068.3(0.2 to 38.5)
Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG003
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG004
Sentinel Cohort: RSV 240 mcg Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination
OG005
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG006
Sentinel Cohort: Placebo Age 50-85 Years
Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00512
OG00612
Title
Denominators
Categories
Title
Measurements
OG00025.0(5.5 to 57.2)
OG00125.0(5.5 to 57.2)
OG0028.3(0.2 to 38.5)
OG0030(0.0 to 26.5)
OG0040(0.0 to 26.5)
OG0058.3(0.2 to 38.5)
OG0060.0(0.0 to 26.5)
OG002
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG003
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG004
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG005
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG006
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG007
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG008
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG009
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG010
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG011
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG012
Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Units
Counts
Participants
OG00041
OG00142
OG00241
OG00340
OG00441
OG00541
OG00641
OG00741
OG00841
OG00941
OG01041
OG01141
OG01241
Title
Denominators
Categories
Title
Measurements
OG00017.1(7.2 to 32.1)
OG00116.7(7.0 to 31.4)
OG00214.6(5.6 to 29.2)
OG00322.5(10.8 to 38.5)
OG00424.4(12.4 to 40.3)
OG00522.0(10.6 to 37.6)
OG0067.3(1.5 to 19.9)
OG00722.0(10.6 to 37.6)
OG0089.8(2.7 to 23.1)
OG00912.2(4.1 to 26.2)
OG01012.2(4.1 to 26.2)
OG01117.1(7.2 to 32.1)
OG0129.8(2.7 to 23.1)
OG002
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG003
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG004
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG005
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG006
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG007
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG008
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG009
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG010
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG011
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG012
Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Units
Counts
Participants
OG00040
OG00141
OG00240
OG00342
OG00440
OG00540
OG00641
OG00741
OG00840
OG00941
OG01042
OG01143
OG01241
Title
Denominators
Categories
Title
Measurements
OG00010.0(2.8 to 23.7)
OG00114.6(5.6 to 29.2)
OG0025.0(0.6 to 16.9)
OG00326.2(13.9 to 42.0)
OG00422.5(10.8 to 38.5)
OG00520.0(9.1 to 35.6)
OG00614.6(5.6 to 29.2)
OG00714.6(5.6 to 29.2)
OG00815.0(5.7 to 29.8)
OG0099.8(2.7 to 23.1)
OG01011.9(4.0 to 25.6)
OG01116.3(6.8 to 30.7)
OG01212.2(4.1 to 26.2)
Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG003
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG004
Sentinel Cohort: RSV 240 mcg Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG005
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG006
Sentinel Cohort: Placebo Age 18-49 Years
Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00512
OG00612
Title
Denominators
Categories
MAEs
Title
Measurements
OG00033.3(9.9 to 65.1)
OG0010(0.0 to 26.5)
OG00225.0(5.5 to 57.2)
OG00316.7(2.1 to 48.4)
OG0048.3(0.2 to 38.5)
OG00525.0(5.5 to 57.2)
OG00616.7(2.1 to 48.4)
SAEs
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG003
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG004
Sentinel Cohort: RSV 240 mcg Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG005
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG006
Sentinel Cohort: Placebo Age 50-85 Years
Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00512
OG00612
Title
Denominators
Categories
MAEs
Title
Measurements
OG00025.0(5.5 to 57.2)
OG00150.0(21.1 to 78.9)
OG00225.0(5.5 to 57.2)
OG00325.0(5.5 to 57.2)
OG00425.0(5.5 to 57.2)
OG00516.7(2.1 to 48.4)
OG00616.7(2.1 to 48.4)
SAEs
Title
Measurements
OG0000(0.0 to 26.5)
OG0010(0.0 to 26.5)
OG0020(0.0 to 26.5)
OG003
OG002
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG003
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG004
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG005
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG006
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.
OG007
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG008
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG009
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG010
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG011
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG012
Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Units
Counts
Participants
OG00041
OG00142
OG00241
OG00340
OG00441
OG00541
OG00641
OG00741
OG00841
OG00941
OG01041
OG01141
OG01241
Title
Denominators
Categories
MAEs
Title
Measurements
OG00022.0(10.6 to 37.6)
OG00114.3(5.4 to 28.5)
OG0029.8(2.7 to 23.1)
OG00317.5(7.3 to 32.8)
OG00422.0(10.6 to 37.6)
OG00519.5(8.8 to 34.9)
OG00612.2(4.1 to 26.2)
OG00724.4(12.4 to 40.3)
OG00824.4(12.4 to 40.3)
OG00922.0(10.6 to 40.3)
OG01024.4(12.4 to 40.3)
OG01122.0(10.6 to 37.6)
OG01222.0(10.6 to 37.6)
SAEs
Title
Measurements
OG0002.4(0.1 to 12.9)
OG0010(0.0 to 8.4)
OG0020(0.0 to 8.6)
OG003
OG002
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG003
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG004
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG005
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG006
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG007
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG008
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG009
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG010
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG011
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG012
Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Units
Counts
Participants
OG00040
OG00141
OG00240
OG00342
OG00440
OG00540
OG00641
OG00741
OG00840
OG00941
OG01042
OG01143
OG01241
Title
Denominators
Categories
MAEs
Title
Measurements
OG00015.0(5.7 to 29.8)
OG00124.4(12.4 to 40.3)
OG00230.0(16.6 to 46.5)
OG00331.0(17.6 to 47.1)
OG00422.5(10.8 to 38.5)
OG00522.5(10.8 to 38.5)
OG00617.1(7.2 to 32.1)
OG00734.1(20.1 to 50.6)
OG00847.5(31.5 to 63.9)
OG00943.9(28.5 to 60.3)
OG01028.6(15.7 to 44.6)
OG01125.6(13.5 to 41.2)
OG01214.6(5.6 to 29.2)
SAEs
Title
Measurements
OG0005.0(0.6 to 16.9)
OG00117.1(7.2 to 32.1)
OG00210.0(2.8 to 23.7)
OG003
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG003
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG004
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG005
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG006
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG007
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG008
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG009
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG010
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG011
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG012
Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Units
Counts
Participants
OG00041
OG00142
OG00241
OG00340
OG00441
OG00541
OG00641
OG00741
OG00841
OG00941
OG01041
OG01141
OG01241
Title
Denominators
Categories
Title
Measurements
OG00019.5(8.8 to 34.9)
OG00114.3(5.4 to 28.5)
OG00219.5(8.8 to 34.9)
OG00310.0(2.8 to 23.7)
OG0047.3(1.5 to 19.9)
OG00517.1(7.2 to 32.1)
OG00622.0(10.6 to 37.6)
OG00714.6(5.6 to 29.2)
OG00826.8(14.2 to 42.9)
OG00926.8(14.2 to 42.9)
OG01019.5(8.8 to 34.9)
OG01117.1(7.2 to 32.1)
OG0129.8(2.7 to 23.1)
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG003
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG004
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG005
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG006
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG007
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG008
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG009
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG010
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG011
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG012
Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Units
Counts
Participants
OG00040
OG00141
OG00240
OG00342
OG00440
OG00540
OG00641
OG00741
OG00840
OG00941
OG01042
OG01143
OG01241
Title
Denominators
Categories
Title
Measurements
OG00010.0(2.8 to 23.7)
OG0017.3(1.5 to 19.9)
OG00220.0(9.1 to 35.6)
OG00321.4(10.3 to 36.8)
OG00425.0(12.7 to 41.2)
OG00530.0(16.6 to 46.5)
OG00612.2(4.1 to 26.2)
OG0079.8(2.7 to 23.1)
OG00832.5(18.6 to 49.1)
OG00924.4(12.4 to 40.3)
OG01011.9(4.0 to 25.6)
OG01118.6(8.4 to 33.4)
OG01217.1(7.2 to 32.1)
OG002
Sentinel Cohort: RSV 120 mcg Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG003
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG004
Sentinel Cohort: RSV 240 mcg Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG005
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years
Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG006
Sentinel Cohort: Placebo Age 18-49 Years
Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00411
OG00511
OG00612
Title
Denominators
Categories
RSV A: before vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
ParticipantsOG00411
ParticipantsOG00511
ParticipantsOG00612
Title
Measurements
OG0001319(639.4 to 2720.0)
OG0011754(1053.6 to 2919.0)
OG0021090(636.6 to 1867.2)
OG003
RSV A: 2 Weeks after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
RSV A: 1 Month after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
RSV A: 2 Months after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
RSV A:3 Months after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00312
RSV A:6 Months after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00312
RSV A: 12 Months after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00312
RSV B: before vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
RSV B: 2 Weeks after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
RSV B: 1 Month after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
RSV B: 2 Months after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
RSV B: 3 Months after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00312
RSV B: 6 Months after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00312
RSV B: 12 Months after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00312
Sentinel Cohort: RSV 120 mcg Age 50-85 Years
Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG003
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG004
Sentinel Cohort: RSV 240 mcg Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.
OG005
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years
Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.
OG006
Sentinel Cohort: Placebo Age 50-85 Years
Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00512
OG00611
Title
Denominators
Categories
RSV A: before vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
ParticipantsOG00412
ParticipantsOG00512
ParticipantsOG00611
Title
Measurements
OG0001904(1278.7 to 2834.4)
OG0011672(1040.7 to 2686.7)
OG0022056(1331.2 to 3173.9)
OG003
RSV A: 2 Weeks after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
RSV A: 1 Month after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
RSV A: 2 Months after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
RSV A:3 Months after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
RSV A:6 Months after vaccination 1
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
RSV A: 12 Months after vaccination 1
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00311
RSV B: before vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
RSV B: 2 Weeks after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
RSV B: 1 Month after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
RSV B: 2 Months after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
RSV B: 3 Months after vaccination 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
RSV B: 6 Months after vaccination 1
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00311
RSV B: 12 Months after vaccination 1
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00311
OG002
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG003
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG004
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG005
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG006
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG007
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG008
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG009
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG010
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG011
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG012
Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Units
Counts
Participants
OG00039
OG00139
OG00240
OG00338
OG00440
OG00540
OG00639
OG00738
OG00840
OG00939
OG01041
OG01140
OG01241
Title
Denominators
Categories
RSV A: before vaccination 1
ParticipantsOG00039
ParticipantsOG00139
ParticipantsOG00240
ParticipantsOG00338
ParticipantsOG00440
ParticipantsOG00540
ParticipantsOG00639
ParticipantsOG00738
ParticipantsOG00840
ParticipantsOG00939
ParticipantsOG01041
ParticipantsOG01140
ParticipantsOG01241
Title
Measurements
OG0001998(1544.9 to 2583.6)
OG0011471(1136.8 to 1904.1)
OG0021518(1124.2 to 2049.1)
OG003
RSV A: 1 Month after vaccination 1
ParticipantsOG00039
ParticipantsOG00139
ParticipantsOG00240
ParticipantsOG00338
RSV A: 2 Months after vaccination 1
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00239
ParticipantsOG00338
RSV A:3 Months after vaccination 1
ParticipantsOG00037
ParticipantsOG00138
ParticipantsOG00239
ParticipantsOG00338
RSV A:6 Months after vaccination 1
ParticipantsOG00037
ParticipantsOG00137
ParticipantsOG00240
ParticipantsOG00338
RSV A: 12 Months after vaccination 1
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00237
ParticipantsOG00333
RSV B: before vaccination 1
ParticipantsOG00039
ParticipantsOG00139
ParticipantsOG00240
ParticipantsOG00338
RSV B: 1 Month after vaccination 1
ParticipantsOG00039
ParticipantsOG00139
ParticipantsOG00240
ParticipantsOG00338
RSV B: 2 Months after vaccination 1
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00239
ParticipantsOG00338
RSV B: 3 Months after vaccination 1
ParticipantsOG00037
ParticipantsOG00138
ParticipantsOG00239
ParticipantsOG00338
RSV B: 6 Months after vaccination 1
ParticipantsOG00037
ParticipantsOG00137
ParticipantsOG00240
ParticipantsOG00338
RSV B: 12 Months after vaccination 1
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00237
ParticipantsOG00333
OG002
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG003
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG004
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG005
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG006
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG007
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG008
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG009
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG010
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG011
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG012
Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Units
Counts
Participants
OG00038
OG00140
OG00240
OG00340
OG00438
OG00540
OG00640
OG00740
OG00840
OG00938
OG01041
OG01143
OG01239
Title
Denominators
Categories
RSV A: before vaccination 1
ParticipantsOG00038
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00340
ParticipantsOG00438
ParticipantsOG00540
ParticipantsOG00640
ParticipantsOG00740
ParticipantsOG00840
ParticipantsOG00938
ParticipantsOG01041
ParticipantsOG01143
ParticipantsOG01239
Title
Measurements
OG0002129(1577.8 to 2872.8)
OG0012096(1518.6 to 2892.0)
OG0022064(1638.5 to 2598.9)
OG003
RSV A: 1 Month after vaccination 1
ParticipantsOG00038
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00340
RSV A: 2 Months after vaccination 1
ParticipantsOG00038
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00340
RSV A:3 Months after vaccination 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00339
RSV A:6 Months after vaccination 1
ParticipantsOG00038
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00339
RSV A: 12 Months after vaccination 1
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00240
ParticipantsOG00337
RSV B: before vaccination 1
ParticipantsOG00038
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00340
RSV B: 1 Month after vaccination 1
ParticipantsOG00038
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00340
RSV B: 2 Months after vaccination 1
ParticipantsOG00038
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00340
RSV B: 3 Months after vaccination 1
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00339
RSV B: 6 Months after vaccination 1
ParticipantsOG00038
ParticipantsOG00140
ParticipantsOG00240
ParticipantsOG00339
RSV B: 12 Months after vaccination 1
ParticipantsOG00038
ParticipantsOG00139
ParticipantsOG00240
ParticipantsOG00337
OG002
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG003
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG004
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG005
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG006
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG007
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG008
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG009
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG010
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG011
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG012
Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Units
Counts
Participants
OG00039
OG00133
OG00240
OG00332
OG00440
OG00533
OG00639
OG00733
OG00840
OG00936
OG01041
OG01131
OG01234
Title
Denominators
Categories
A-H1N1: before SIIV
Title
Measurements
OG00044.5(30.34 to 65.26)
OG00125.0(17.15 to 36.51)
OG00238.0(25.74 to 56.03)
OG00333.7(22.47 to 50.53)
OG00418.9(13.51 to 26.47)
OG00527.0(16.99 to 42.96)
OG00629.6(19.01 to 45.99)
OG00726.1(16.68 to 40.85)
OG00820.5(14.21 to 29.48)
OG00928.7(18.16 to 45.28)
OG01032.1(22.97 to 44.88)
OG01122.7(14.61 to 35.35)
OG01233.5(21.85 to 51.43)
A-H1N1: 1 month after SIIV
Title
Measurements
OG00077.2(55.13 to 108.07)
OG00195.3(65.73 to 138.06)
OG00285.8(63.75 to 115.37)
OG003
A-H3N2: before SIIV
Title
Measurements
OG00035.1(23.42 to 52.58)
OG00125.4(16.15 to 39.89)
OG00232.7(22.27 to 47.91)
OG003
A-H3N2: 1 month after SIIV
Title
Measurements
OG00077.7(54.76 to 110.11)
OG001129.6(84.87 to 198.00)
OG00281.4(58.32 to 113.57)
OG003
B1: before SIIV
Title
Measurements
OG00013.2(9.24 to 18.73)
OG00110.3(7.64 to 13.87)
OG00210.8(7.81 to 14.93)
OG003
B1: 1 month after SIIV
Title
Measurements
OG00023.5(17.09 to 32.25)
OG00141.7(27.86 to 62.52)
OG00229.3(20.47 to 41.97)
OG003
B2: before SIIV
Title
Measurements
OG00016.3(11.09 to 23.85)
OG00111.7(8.93 to 15.24)
OG00212.5(9.29 to 16.71)
OG003
B2: 1 month after SIIV
Title
Measurements
OG00029.0(21.07 to 40.04)
OG00139.4(27.06 to 57.46)
OG00227.8(20.40 to 37.97)
OG003
OG002
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG003
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG004
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG005
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG006
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG007
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
OG008
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG009
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG010
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG011
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
OG012
Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.