Respiratory Tract Infections
Conditions
Keywords
Respiratory tract infections, RSV, vaccine
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.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Observer blind
Intervention model description
Parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Healthy adults who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. 3. Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures. 4. 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. 5. Sentinel-cohort subjects only: Male and female adults aged 18 to 85 years at the time of enrollment (signing of the ICD). 6. 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
1. Sentinel-cohort subjects only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality. 2. 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. 3. 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. 4. Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation. 5. Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV). 6. Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt throughout the study of nonstudy RSV vaccine. 7. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product(s). 8. Immunocompromised subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 9. 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. 10. Subject with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention including but not limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1). 11. Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study. 12. 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. 13. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 14. Women who are pregnant or breastfeeding. 15. Expanded-cohort subjects only: Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration. 16. Expanded-cohort subjects only: Allergy to egg proteins (egg or egg products) or chicken proteins.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 | Within 1 month after vaccination 2 (upto Day 70) | 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. |
| Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination | Within 1 month after vaccination 1 (up to 35 days) | 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. |
| 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 | Upto 12 months after vaccination (up to 378 days) | 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. |
| Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | Upto 12 months after vaccination (upto 378 days) | 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. |
| Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | Upto 12 months after vaccination 1 (upto 378 days) | 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. |
| Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | Upto 12 months after vaccination 1 (upto 378 days) | 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. |
| Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 | Within 1 month after vaccination 2 (upto Day 70) | 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. |
| Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Within 14 days after vaccination 1 on Day 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. |
| Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | 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. |
| Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | 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. |
| Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Within 14 days after vaccination 1 on Day 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. |
| Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | 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. |
| Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | 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. |
| Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Within 14 days after vaccination 1 on Day 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. |
| Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Within 14 days after vaccination 1 on Day 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. |
| Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination | Within 1 month after vaccination (up to 35 days) | 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. |
| Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination | Within 1 month after vaccination (up to 35 days) | 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. |
| Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 | Within 1 month after vaccination 1 (up to 35 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination | 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. |
| Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | Before vaccination, 1, 2, 3, 6 and 12 months after vaccination | 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. |
| Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | Before vaccination, 1, 2, 3, 6 and 12 months after vaccination | 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. |
| 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) | Before vaccination and 1 Month after SIIV vaccination | 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. |
| 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) | Before vaccination and 1 Month after SIIV vaccination | 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. |
| 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) | Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 41 |
| 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. | 42 |
| 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. | 41 |
| 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. | 40 |
| 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. | 41 |
| 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. | 41 |
| 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. | 41 |
| 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. | 41 |
| 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. | 41 |
| 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. | 41 |
| 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. | 41 |
| 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. | 41 |
| 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. | 41 |
| 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. | 40 |
| 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. | 41 |
| 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. | 40 |
| 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. | 42 |
| 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. | 40 |
| 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. | 40 |
| 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. | 41 |
| 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. | 41 |
| 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. | 40 |
| 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. | 41 |
| 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. | 42 |
| 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. | 43 |
| 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. | 41 |
| Total | 1,233 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 | FG025 | FG026 | FG027 | FG028 | FG029 | FG030 | FG031 | FG032 | FG033 | FG034 | FG035 | FG036 | FG037 | FG038 | FG039 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 1 | 1 | 0 | 1 | 1 | 2 | 4 | 3 | 4 | 3 | 5 | 5 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 3 | 1 | 1 |
| Overall Study | No longer meets eligibility criteria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 3 | 0 | 0 | 1 | 0 | 1 | 0 | 3 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Randomized but not vaccinated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Screen Failure | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 2 | 3 | 1 | 3 | 1 | 1 | 2 | 2 | 4 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years | Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years | Sentinel Cohort: RSV 120 mcg Age 50-85 Years | Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years | Sentinel Cohort: RSV 240 mcg Age 50-85 Years | Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years | Sentinel Cohort: Placebo Age 50-85 Years | Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo Age 18-49 Years | Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years | Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years | Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years | Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years | Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years | Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years | Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years | Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years | Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years | Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years | Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years | Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years | Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 32.2 Years STANDARD_DEVIATION 9.5 | 34.0 Years STANDARD_DEVIATION 9 | 34.8 Years STANDARD_DEVIATION 8 | 34.2 Years STANDARD_DEVIATION 8.7 | 43.3 Years STANDARD_DEVIATION 4.8 | 36.3 Years STANDARD_DEVIATION 8.4 | 35.2 Years STANDARD_DEVIATION 9.4 | 65.4 Years STANDARD_DEVIATION 9.9 | 66.3 Years STANDARD_DEVIATION 9.7 | 63.7 Years STANDARD_DEVIATION 7.4 | 62.6 Years STANDARD_DEVIATION 8.6 | 62.1 Years STANDARD_DEVIATION 9.8 | 61.3 Years STANDARD_DEVIATION 7.7 | 61.3 Years STANDARD_DEVIATION 9.8 | 33.4 Years STANDARD_DEVIATION 8.2 | 32.6 Years STANDARD_DEVIATION 9.1 | 33.0 Years STANDARD_DEVIATION 8.6 | 34.1 Years STANDARD_DEVIATION 9.3 | 34.1 Years STANDARD_DEVIATION 8.5 | 36.8 Years STANDARD_DEVIATION 8.8 | 34.1 Years STANDARD_DEVIATION 8.7 | 33.1 Years STANDARD_DEVIATION 9.4 | 36.2 Years STANDARD_DEVIATION 8.9 | 34.7 Years STANDARD_DEVIATION 8.9 | 33.9 Years STANDARD_DEVIATION 8.5 | 34.6 Years STANDARD_DEVIATION 7.7 | 33.6 Years STANDARD_DEVIATION 8.5 | 72.6 Years STANDARD_DEVIATION 5.9 | 71.9 Years STANDARD_DEVIATION 4.8 | 72.4 Years STANDARD_DEVIATION 5.6 | 72.8 Years STANDARD_DEVIATION 5.1 | 70.9 Years STANDARD_DEVIATION 5.5 | 71.7 Years STANDARD_DEVIATION 5.4 | 72.2 Years STANDARD_DEVIATION 4.7 | 71.3 Years STANDARD_DEVIATION 4.8 | 72.3 Years STANDARD_DEVIATION 5 | 71.6 Years STANDARD_DEVIATION 5.2 | 71.4 Years STANDARD_DEVIATION 5.1 | 70.7 Years STANDARD_DEVIATION 4.9 | 70.9 Years STANDARD_DEVIATION 4.7 | 52.47 Years STANDARD_DEVIATION 19.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 4 Participants | 5 Participants | 7 Participants | 5 Participants | 4 Participants | 7 Participants | 6 Participants | 5 Participants | 3 Participants | 5 Participants | 6 Participants | 4 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 3 Participants | 4 Participants | 3 Participants | 1 Participants | 5 Participants | 2 Participants | 1 Participants | 5 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 10 Participants | 10 Participants | 11 Participants | 11 Participants | 11 Participants | 8 Participants | 12 Participants | 10 Participants | 11 Participants | 11 Participants | 10 Participants | 10 Participants | 12 Participants | 37 Participants | 37 Participants | 34 Participants | 35 Participants | 37 Participants | 34 Participants | 35 Participants | 36 Participants | 38 Participants | 36 Participants | 35 Participants | 36 Participants | 38 Participants | 38 Participants | 39 Participants | 38 Participants | 41 Participants | 37 Participants | 37 Participants | 37 Participants | 37 Participants | 39 Participants | 36 Participants | 40 Participants | 40 Participants | 36 Participants | 1112 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 10 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants | 2 Participants | 1 Participants | 4 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 4 Participants | 3 Participants | 1 Participants | 2 Participants | 10 Participants | 7 Participants | 8 Participants | 8 Participants | 6 Participants | 8 Participants | 9 Participants | 8 Participants | 13 Participants | 7 Participants | 7 Participants | 9 Participants | 9 Participants | 4 Participants | 6 Participants | 1 Participants | 5 Participants | 3 Participants | 3 Participants | 2 Participants | 6 Participants | 5 Participants | 3 Participants | 3 Participants | 6 Participants | 4 Participants | 188 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants |
| Race (NIH/OMB) White | 10 Participants | 7 Participants | 10 Participants | 8 Participants | 10 Participants | 7 Participants | 9 Participants | 9 Participants | 11 Participants | 9 Participants | 7 Participants | 8 Participants | 9 Participants | 8 Participants | 30 Participants | 32 Participants | 32 Participants | 28 Participants | 31 Participants | 31 Participants | 30 Participants | 29 Participants | 27 Participants | 32 Participants | 30 Participants | 28 Participants | 29 Participants | 35 Participants | 34 Participants | 38 Participants | 36 Participants | 34 Participants | 37 Participants | 37 Participants | 33 Participants | 35 Participants | 37 Participants | 39 Participants | 36 Participants | 36 Participants | 978 Participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 6 Participants | 10 Participants | 9 Participants | 9 Participants | 5 Participants | 7 Participants | 8 Participants | 7 Participants | 5 Participants | 10 Participants | 9 Participants | 6 Participants | 27 Participants | 28 Participants | 27 Participants | 25 Participants | 29 Participants | 29 Participants | 26 Participants | 25 Participants | 29 Participants | 29 Participants | 28 Participants | 29 Participants | 29 Participants | 17 Participants | 23 Participants | 20 Participants | 25 Participants | 24 Participants | 22 Participants | 22 Participants | 23 Participants | 26 Participants | 26 Participants | 26 Participants | 20 Participants | 29 Participants | 771 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 6 Participants | 2 Participants | 3 Participants | 3 Participants | 7 Participants | 5 Participants | 4 Participants | 5 Participants | 7 Participants | 2 Participants | 3 Participants | 6 Participants | 14 Participants | 14 Participants | 14 Participants | 15 Participants | 12 Participants | 12 Participants | 15 Participants | 16 Participants | 12 Participants | 12 Participants | 13 Participants | 12 Participants | 12 Participants | 23 Participants | 18 Participants | 20 Participants | 17 Participants | 16 Participants | 18 Participants | 19 Participants | 18 Participants | 14 Participants | 15 Participants | 16 Participants | 23 Participants | 12 Participants | 462 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk | EG030 affected / at risk | EG031 affected / at risk | EG032 affected / at risk | EG033 affected / at risk | EG034 affected / at risk | EG035 affected / at risk | EG036 affected / at risk | EG037 affected / at risk | EG038 affected / at risk | EG039 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 1 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 41 | 0 / 41 | 0 / 41 | 0 / 41 | 1 / 41 | 0 / 41 | 0 / 41 | 0 / 41 | 0 / 42 | 0 / 40 | 1 / 41 | 1 / 41 | 0 / 43 | 0 / 42 | 0 / 40 | 1 / 41 | 0 / 41 | 0 / 41 | 0 / 41 | 0 / 40 | 0 / 40 | 0 / 40 | 1 / 41 | 0 / 40 | 0 / 42 | 0 / 41 |
| other Total, other adverse events | 9 / 12 | 6 / 12 | 7 / 12 | 6 / 12 | 7 / 12 | 7 / 12 | 8 / 12 | 10 / 12 | 11 / 12 | 9 / 12 | 8 / 12 | 5 / 12 | 5 / 12 | 4 / 12 | 31 / 41 | 36 / 41 | 33 / 41 | 35 / 41 | 35 / 41 | 35 / 41 | 31 / 41 | 24 / 41 | 27 / 42 | 22 / 40 | 25 / 41 | 28 / 41 | 33 / 43 | 32 / 42 | 30 / 40 | 33 / 41 | 35 / 41 | 32 / 41 | 38 / 41 | 22 / 40 | 20 / 40 | 21 / 40 | 21 / 41 | 32 / 40 | 29 / 42 | 21 / 41 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 2 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 1 / 12 | 0 / 12 | 1 / 41 | 0 / 41 | 1 / 41 | 0 / 41 | 2 / 41 | 1 / 41 | 2 / 41 | 7 / 41 | 8 / 42 | 2 / 40 | 2 / 41 | 5 / 41 | 3 / 43 | 0 / 42 | 1 / 40 | 2 / 41 | 2 / 41 | 3 / 41 | 3 / 41 | 2 / 40 | 4 / 40 | 4 / 40 | 7 / 41 | 5 / 40 | 4 / 42 | 3 / 41 |
Outcome results
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.
Time frame: Within 1 month after vaccination 2 (upto Day 70)
Population: All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 | 19.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 | 14.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 | 19.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 | 7.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 | 17.1 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 | 22.0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 | 14.6 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 | 26.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 | 26.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 | 19.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 | 17.1 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 | 9.8 Percentage of participants |
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.
Time frame: Within 1 month after vaccination 1 (up to 35 days)
Population: All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 | 17.1 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 | 14.6 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 | 22.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 | 24.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 | 22.0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 | 7.3 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 | 22.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 | 9.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 | 12.2 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 | 12.2 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 | 17.1 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 | 9.8 Percentage of participants |
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.
Time frame: Within 14 days after vaccination 1 on Day 1
Population: All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 34.1 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 2.4 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 2.4 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 12.2 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 7.1 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 4.8 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 31.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 4.8 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 4.8 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 26.8 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 41.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 20.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 32.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 9.8 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 36.6 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 7.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 43.9 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 9.8 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 48.8 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 12.2 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 2.4 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 2.4 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 5.0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 55.0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 12.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 7.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 14.6 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 24.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 34.1 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 9.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 51.2 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 9.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 48.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 9.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 9.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 17.1 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 2.4 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 2.4 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 14.6 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 0 Percentage of participants |
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.
Time frame: Upto 12 months after vaccination 1 (upto 378 days)
Population: All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | MAEs | 22.0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | SAEs | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | MAEs | 14.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | SAEs | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | MAEs | 9.8 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | SAEs | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | MAEs | 17.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | SAEs | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | SAEs | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | MAEs | 22.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | SAEs | 4.9 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | MAEs | 19.5 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | MAEs | 12.2 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | SAEs | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | MAEs | 24.4 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | SAEs | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | MAEs | 24.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | SAEs | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | SAEs | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | MAEs | 22.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | SAEs | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | MAEs | 24.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | MAEs | 22.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | SAEs | 7.3 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | SAEs | 2.4 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 | MAEs | 22.0 Percentage of participants |
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.
Time frame: Within 14 days after vaccination 1 on Day 1
Population: All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 2.4 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 12.2 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 7.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 24.4 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 7.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 12.2 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 29.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 7.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 14.6 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 2.4 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 2.4 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 31.7 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 9.8 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 2.4 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 4.9 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 14.6 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 28.6 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 7.1 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 7.1 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 4.8 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 7.1 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 11.9 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 11.9 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 4.8 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 14.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 21.4 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 28.6 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 12.2 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 19.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 22.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 7.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 24.4 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 19.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 4.9 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 14.6 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 34.1 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 9.8 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 19.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 17.1 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 17.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 22.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 32.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 12.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 12.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 27.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 7.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 4.9 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 4.9 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 4.9 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 17.1 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 9.8 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 4.9 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 4.9 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 12.2 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 19.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 19.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 29.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 29.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 12.2 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 22.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 26.8 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 17.1 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 22.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 7.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 7.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 24.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 4.9 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 17.1 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 7.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 19.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 19.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 9.8 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 7.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 4.9 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 7.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 17.1 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 17.1 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 29.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 14.6 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 14.6 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 9.8 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 29.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 43.9 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 4.9 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 19.5 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 2.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 22.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 2.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 7.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 2.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 12.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 27.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 12.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 12.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 17.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 22.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 37.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 2.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 20.0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 27.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 9.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 14.6 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 19.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 19.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 19.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 12.2 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 29.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 14.6 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 29.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 14.6 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 12.2 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 39.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 12.2 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 24.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 29.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 14.6 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 19.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 29.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 26.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 9.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 36.6 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 17.1 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 19.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 26.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 24.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 9.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 22.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 9.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 19.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 19.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 17.1 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 14.6 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 12.2 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 4.9 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 19.5 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 9.8 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 2.4 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 9.8 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 4.9 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 2.4 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 12.2 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 19.5 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 12.2 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
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.
Time frame: Within 1 month after vaccination 2 (upto Day 70)
Population: All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 | 7.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 | 20.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 | 21.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 | 30.0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 | 12.2 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 | 9.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 | 32.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 | 24.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 | 11.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 | 18.6 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 | 17.1 Percentage of participants |
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.
Time frame: Within 1 month after vaccination 1 (up to 35 days)
Population: All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination | 14.6 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination | 26.2 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination | 22.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination | 20.0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination | 14.6 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination | 14.6 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination | 15.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination | 9.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination | 11.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination | 16.3 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination | 12.2 Percentage of participants |
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.
Time frame: Within 14 days after vaccination 1 on Day 1
Population: All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 25.0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 2.5 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 7.5 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 22.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 23.8 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 7.1 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 4.8 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 22.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 7.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 26.8 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 2.4 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 2.4 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 2.4 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 19.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 2.4 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 32.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 2.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 5.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 19.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 4.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 19.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 2.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 14.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 2.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 2.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 4.7 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 4.7 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 2.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: moderate | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: mild | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: moderate | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: mild | 5.0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: moderate | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Pain at injection site: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Redness: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 | Swelling: mild | 2.5 Percentage of participants |
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.
Time frame: Upto 12 months after vaccination 1 (upto 378 days)
Population: All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | MAEs | 15.0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | SAEs | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | MAEs | 24.4 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | SAEs | 17.1 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | MAEs | 30.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | SAEs | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | MAEs | 31.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | SAEs | 19.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | SAEs | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | MAEs | 22.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | SAEs | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | MAEs | 22.5 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | MAEs | 17.1 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | SAEs | 17.1 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | MAEs | 34.1 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | SAEs | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | MAEs | 47.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | SAEs | 10.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | SAEs | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | MAEs | 43.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | SAEs | 7.1 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | MAEs | 28.6 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | MAEs | 25.6 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | SAEs | 7.0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | SAEs | 7.3 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 | MAEs | 14.6 Percentage of participants |
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.
Time frame: Within 14 days after vaccination 1 on Day 1
Population: All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 12.5 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 5.0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 7.5 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 12.5 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 15.0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 5.0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 7.5 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 7.5 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 17.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 7.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 12.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 15.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 7.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 7.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 7.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 12.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 15.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 20.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 7.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 26.2 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 11.9 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 14.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 14.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 9.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 9.5 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 7.1 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 2.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 15.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 12.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 7.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 15.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 7.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 7.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 7.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 12.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 10.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 7.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 5.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 2.5 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 7.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 2.4 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 2.4 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 4.9 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 7.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 19.5 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 14.6 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 7.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 4.9 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 2.4 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 7.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 14.6 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 14.6 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 2.4 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 4.9 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 2.4 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 2.4 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 7.3 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 4.9 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 22.0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 14.6 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 2.4 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 19.5 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 7.3 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 4.9 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 7.3 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 7.3 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 14.6 Percentage of participants |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 2.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 17.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 2.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 10.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 5.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 12.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 22.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 20.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 2.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 7.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 2.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 7.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 5.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 17.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 15.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 24.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 4.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 9.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 19.5 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 9.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 9.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 17.1 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 7.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 19.0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 23.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 21.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 11.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 4.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 16.7 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 21.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 7.1 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 4.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 4.8 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 14.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 21.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 2.4 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 4.7 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 9.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 2.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 20.9 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 2.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 2.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 4.7 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 16.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 4.7 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 2.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 4.7 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 2.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 2.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 2.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 2.3 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 11.6 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 4.7 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: moderate | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: moderate | 7.5 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: mild | 7.5 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: moderate | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: severe | 2.5 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: mild | 20.0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: >=38.0 degree C | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: severe | 2.5 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: moderate | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Muscle pain: mild | 7.5 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: mild | 7.5 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: mild | 5.0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: moderate | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Diarrhea: moderate | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Nausea: mild | 5.0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fatigue: moderate | 7.5 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: severe | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Headache: moderate | 2.5 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Vomiting: mild | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Fever: mild | 0 Percentage of participants |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 | Joint pain: severe | 0 Percentage of participants |
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.
Time frame: Within 1 month after vaccination (up to 35 days)
Population: All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination | 16.7 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination | 8.3 Percentage of participants |
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.
Time frame: Within 14 days after vaccination
Population: All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: mild | 50.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: moderate | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: mild | 58.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: mild | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: mild | 75.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: moderate | 18.2 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: mild | 58.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: mild | 16.7 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination | Redness: moderate | 0 Percentage of participants |
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.
Time frame: Upto 12 months after vaccination (up to 378 days)
Population: All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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 | MAEs | 33.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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 | SAEs | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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 | MAEs | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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 | SAEs | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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 | MAEs | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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 | SAEs | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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 | MAEs | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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 | SAEs | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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 | MAEs | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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 | SAEs | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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 | MAEs | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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 | SAEs | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | 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 | MAEs | 16.7 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | 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 | SAEs | 0 Percentage of participants |
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.
Time frame: Within 14 days after vaccination
Population: All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: severe | 8.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: moderate | 25.0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: mild | 50.0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: severe | 8.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: moderate | 16.7 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: moderate | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: mild | 41.7 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: moderate | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: mild | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: >=38.0 degree C | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: moderate | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: mild | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: moderate | 0.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: moderate | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: moderate | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: moderate | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: mild | 33.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: mild | 33.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: mild | 33.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: moderate | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: severe | 9.1 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: severe | 9.1 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: mild | 18.2 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: mild | 27.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: severe | 9.1 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: moderate | 36.4 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: moderate | 27.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: severe | 9.1 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: moderate | 9.1 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: moderate | 18.2 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: moderate | 9.1 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: mild | 9.1 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: mild | 27.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: moderate | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: moderate | 33.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: severe | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: moderate | 33.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: >=38.0 degree C | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: mild | 41.7 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: mild | 8.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: mild | 25.0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: mild | 8.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: mild | 8.3 Percentage of participants |
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.
Time frame: Within 1 month after vaccination (up to 35 days)
Population: All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination | 8.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination | 0.0 Percentage of participants |
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.
Time frame: Within 14 days after vaccination
Population: All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: moderate | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Swelling: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Pain at injection site: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination | Redness: mild | 0 Percentage of participants |
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.
Time frame: Upto 12 months after vaccination (upto 378 days)
Population: All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | MAEs | 25.0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | SAEs | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | MAEs | 50.0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | SAEs | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | MAEs | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | SAEs | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | MAEs | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | SAEs | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | MAEs | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | SAEs | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | MAEs | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | SAEs | 16.7 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | MAEs | 16.7 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination | SAEs | 0 Percentage of participants |
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.
Time frame: Within 14 days after vaccination
Population: All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: mild | 41.7 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain:moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: mild | 33.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: moderate | 33.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: severe | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: moderate | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: mild | 33.3 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain:moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: moderate | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: mild | 33.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain:moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: mild | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: mild | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain:moderate | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: moderate | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: moderate | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: mild | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain:moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: mild | 25.0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain:moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: mild | 16.7 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: mild | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: mild | 8.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: moderate | 16.7 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: mild | 8.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: Grade 4 | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain:moderate | 8.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Diarrhea: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: mild | 16.7 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: >=38.0 degree C | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fatigue: severe | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Headache: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Joint pain: moderate | 8.3 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Fever: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Vomiting: moderate | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Nausea: mild | 0 Percentage of participants |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination | Muscle pain: severe | 0 Percentage of participants |
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.
Time frame: Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 2 Months after vaccination 1 | 10259 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:3 Months after vaccination 1 | 11164 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 1 Month after vaccination 1 | 17482 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 3 Months after vaccination 1 | 11694 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 12 Months after vaccination 1 | 7679 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 1 Month after vaccination 1 | 17583 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 12 Months after vaccination 1 | 7539 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 2 Months after vaccination 1 | 10247 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: before vaccination 1 | 1998 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: before vaccination 1 | 1847 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:6 Months after vaccination 1 | 8403 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 6 Months after vaccination 1 | 8102 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 1 Month after vaccination 1 | 21728 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:3 Months after vaccination 1 | 12664 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:6 Months after vaccination 1 | 8118 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 2 Months after vaccination 1 | 11976 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 1 Month after vaccination 1 | 19561 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 12 Months after vaccination 1 | 7050 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: before vaccination 1 | 1475 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: before vaccination 1 | 1471 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 2 Months after vaccination 1 | 11771 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 6 Months after vaccination 1 | 8411 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 12 Months after vaccination 1 | 7413 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 3 Months after vaccination 1 | 12016 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: before vaccination 1 | 1516 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 1 Month after vaccination 1 | 18762 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 2 Months after vaccination 1 | 10326 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 6 Months after vaccination 1 | 9954 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 3 Months after vaccination 1 | 12852 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 2 Months after vaccination 1 | 11441 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 1 Month after vaccination 1 | 17460 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:6 Months after vaccination 1 | 9568 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: before vaccination 1 | 1518 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 12 Months after vaccination 1 | 7640 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:3 Months after vaccination 1 | 12042 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 12 Months after vaccination 1 | 7651 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:6 Months after vaccination 1 | 9533 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 1 Month after vaccination 1 | 18064 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 2 Months after vaccination 1 | 12522 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 3 Months after vaccination 1 | 11719 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 1 Month after vaccination 1 | 16835 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:3 Months after vaccination 1 | 12773 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 12 Months after vaccination 1 | 7629 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: before vaccination 1 | 1586 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 6 Months after vaccination 1 | 8667 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: before vaccination 1 | 1768 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 2 Months after vaccination 1 | 11253 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 12 Months after vaccination 1 | 9062 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 1 Month after vaccination 1 | 18929 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 2 Months after vaccination 1 | 10486 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:3 Months after vaccination 1 | 9205 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 1 Month after vaccination 1 | 17760 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:6 Months after vaccination 1 | 6492 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 2 Months after vaccination 1 | 9595 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: before vaccination 1 | 1297 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 12 Months after vaccination 1 | 4889 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 12 Months after vaccination 1 | 5778 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: before vaccination 1 | 1460 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 6 Months after vaccination 1 | 6640 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 3 Months after vaccination 1 | 9953 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: before vaccination 1 | 1502 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 12 Months after vaccination 1 | 7747 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 12 Months after vaccination 1 | 8435 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 1 Month after vaccination 1 | 24395 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: before vaccination 1 | 1713 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:6 Months after vaccination 1 | 10324 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 3 Months after vaccination 1 | 13011 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 2 Months after vaccination 1 | 14223 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 1 Month after vaccination 1 | 22628 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 2 Months after vaccination 1 | 14140 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:3 Months after vaccination 1 | 13801 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 6 Months after vaccination 1 | 9482 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 2 Months after vaccination 1 | 15754 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:3 Months after vaccination 1 | 15360 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:6 Months after vaccination 1 | 10005 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 12 Months after vaccination 1 | 9174 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: before vaccination 1 | 1739 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 1 Month after vaccination 1 | 23560 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 2 Months after vaccination 1 | 15173 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 3 Months after vaccination 1 | 13364 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 6 Months after vaccination 1 | 9702 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 12 Months after vaccination 1 | 8492 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: before vaccination 1 | 1862 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 1 Month after vaccination 1 | 26465 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 3 Months after vaccination 1 | 11333 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 1 Month after vaccination 1 | 22928 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 1 Month after vaccination 1 | 25860 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 2 Months after vaccination 1 | 13518 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: before vaccination 1 | 1733 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 6 Months after vaccination 1 | 8836 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 2 Months after vaccination 1 | 11716 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 12 Months after vaccination 1 | 7177 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: before vaccination 1 | 1933 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:3 Months after vaccination 1 | 13663 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 12 Months after vaccination 1 | 8231 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:6 Months after vaccination 1 | 10237 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: before vaccination 1 | 1480 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: before vaccination 1 | 1733 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 2 Months after vaccination 1 | 13790 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:6 Months after vaccination 1 | 7768 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 3 Months after vaccination 1 | 10567 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 2 Months after vaccination 1 | 12850 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 1 Month after vaccination 1 | 23783 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 6 Months after vaccination 1 | 7244 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 1 Month after vaccination 1 | 23481 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:3 Months after vaccination 1 | 11805 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 12 Months after vaccination 1 | 6919 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 12 Months after vaccination 1 | 6078 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:6 Months after vaccination 1 | 10343 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:3 Months after vaccination 1 | 14570 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 2 Months after vaccination 1 | 16485 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 1 Month after vaccination 1 | 29332 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: before vaccination 1 | 1640 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 3 Months after vaccination 1 | 14638 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 12 Months after vaccination 1 | 6983 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 1 Month after vaccination 1 | 31571 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: before vaccination 1 | 1520 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 12 Months after vaccination 1 | 7086 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 6 Months after vaccination 1 | 11073 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 2 Months after vaccination 1 | 14999 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 12 Months after vaccination 1 | 6133 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 1 Month after vaccination 1 | 21150 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 3 Months after vaccination 1 | 10322 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: before vaccination 1 | 1363 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 2 Months after vaccination 1 | 11533 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 6 Months after vaccination 1 | 8235 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 12 Months after vaccination 1 | 6769 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:6 Months after vaccination 1 | 8823 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: before vaccination 1 | 1522 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:3 Months after vaccination 1 | 12273 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 1 Month after vaccination 1 | 21196 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 2 Months after vaccination 1 | 11148 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 12 Months after vaccination 1 | 5658 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: before vaccination 1 | 1625 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:3 Months after vaccination 1 | 10764 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 6 Months after vaccination 1 | 8856 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: before vaccination 1 | 1584 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 3 Months after vaccination 1 | 11146 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 2 Months after vaccination 1 | 14024 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 1 Month after vaccination 1 | 26938 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 2 Months after vaccination 1 | 12812 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 1 Month after vaccination 1 | 28166 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:6 Months after vaccination 1 | 8210 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 12 Months after vaccination 1 | 5494 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 3 Months after vaccination 1 | 1839 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 1 Month after vaccination 1 | 1748 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 12 Months after vaccination 1 | 2017 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: before vaccination 1 | 1750 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 12 Months after vaccination 1 | 1994 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:3 Months after vaccination 1 | 1718 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 2 Months after vaccination 1 | 1252 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 2 Months after vaccination 1 | 1447 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: 6 Months after vaccination 1 | 2171 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A:6 Months after vaccination 1 | 2031 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV A: 1 Month after vaccination 1 | 1883 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) | RSV B: before vaccination 1 | 1783 Titers |
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.
Time frame: Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:3 Months after vaccination 1 | 12010 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 2 Months after vaccination 1 | 9452 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:6 Months after vaccination 1 | 8452 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: before vaccination 1 | 2198 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 6 Months after vaccination 1 | 8429 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 1 Month after vaccination 1 | 15172 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 12 Months after vaccination 1 | 7467 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 1 Month after vaccination 1 | 16007 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 3 Months after vaccination 1 | 12578 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: before vaccination 1 | 2129 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 2 Months after vaccination 1 | 9162 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 12 Months after vaccination 1 | 7732 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 12 Months after vaccination 1 | 7891 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 6 Months after vaccination 1 | 11417 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:3 Months after vaccination 1 | 14230 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 2 Months after vaccination 1 | 13199 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 12 Months after vaccination 1 | 7969 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: before vaccination 1 | 1862 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:6 Months after vaccination 1 | 11903 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 1 Month after vaccination 1 | 20417 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 3 Months after vaccination 1 | 13735 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: before vaccination 1 | 2096 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 2 Months after vaccination 1 | 14085 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 1 Month after vaccination 1 | 20553 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 2 Months after vaccination 1 | 9928 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 3 Months after vaccination 1 | 9741 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:3 Months after vaccination 1 | 10362 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 12 Months after vaccination 1 | 6518 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 12 Months after vaccination 1 | 6445 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 1 Month after vaccination 1 | 14905 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 1 Month after vaccination 1 | 15169 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: before vaccination 1 | 2064 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:6 Months after vaccination 1 | 8444 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: before vaccination 1 | 1999 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 6 Months after vaccination 1 | 7869 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 2 Months after vaccination 1 | 9922 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 3 Months after vaccination 1 | 15856 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: before vaccination 1 | 2423 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 12 Months after vaccination 1 | 9200 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 1 Month after vaccination 1 | 19625 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 6 Months after vaccination 1 | 11739 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 2 Months after vaccination 1 | 15484 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: before vaccination 1 | 2461 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:3 Months after vaccination 1 | 15345 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 2 Months after vaccination 1 | 16107 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:6 Months after vaccination 1 | 10827 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 1 Month after vaccination 1 | 20421 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 12 Months after vaccination 1 | 9143 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 12 Months after vaccination 1 | 7942 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 1 Month after vaccination 1 | 24257 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:6 Months after vaccination 1 | 11871 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 3 Months after vaccination 1 | 14163 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 1 Month after vaccination 1 | 25065 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 12 Months after vaccination 1 | 7573 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 2 Months after vaccination 1 | 16288 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: before vaccination 1 | 2314 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 6 Months after vaccination 1 | 10606 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: before vaccination 1 | 2269 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:3 Months after vaccination 1 | 16637 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 2 Months after vaccination 1 | 14496 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 2 Months after vaccination 1 | 10893 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: before vaccination 1 | 2194 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 3 Months after vaccination 1 | 11927 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 2 Months after vaccination 1 | 12740 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:6 Months after vaccination 1 | 10202 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: before vaccination 1 | 2269 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 6 Months after vaccination 1 | 9270 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 1 Month after vaccination 1 | 18648 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 12 Months after vaccination 1 | 8639 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 1 Month after vaccination 1 | 22318 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 12 Months after vaccination 1 | 6634 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:3 Months after vaccination 1 | 14957 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 6 Months after vaccination 1 | 10384 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: before vaccination 1 | 2578 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 1 Month after vaccination 1 | 23566 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 2 Months after vaccination 1 | 11939 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:3 Months after vaccination 1 | 13675 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:6 Months after vaccination 1 | 10226 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 12 Months after vaccination 1 | 7731 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: before vaccination 1 | 2685 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 1 Month after vaccination 1 | 24158 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 2 Months after vaccination 1 | 11605 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 3 Months after vaccination 1 | 13631 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 12 Months after vaccination 1 | 7449 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 3 Months after vaccination 1 | 16675 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 2 Months after vaccination 1 | 17024 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 1 Month after vaccination 1 | 30071 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:3 Months after vaccination 1 | 16424 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: before vaccination 1 | 2032 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:6 Months after vaccination 1 | 13148 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 1 Month after vaccination 1 | 27600 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 12 Months after vaccination 1 | 9340 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 12 Months after vaccination 1 | 9256 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: before vaccination 1 | 2089 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 2 Months after vaccination 1 | 15840 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 6 Months after vaccination 1 | 13562 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 12 Months after vaccination 1 | 9855 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 2 Months after vaccination 1 | 14438 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 3 Months after vaccination 1 | 18557 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: before vaccination 1 | 2586 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:6 Months after vaccination 1 | 10769 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 1 Month after vaccination 1 | 27996 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: before vaccination 1 | 2203 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 6 Months after vaccination 1 | 11710 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:3 Months after vaccination 1 | 16089 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 12 Months after vaccination 1 | 9738 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 2 Months after vaccination 1 | 17255 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 1 Month after vaccination 1 | 22184 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:3 Months after vaccination 1 | 12200 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 3 Months after vaccination 1 | 13452 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 2 Months after vaccination 1 | 14542 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 12 Months after vaccination 1 | 6809 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 1 Month after vaccination 1 | 21601 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 2 Months after vaccination 1 | 16376 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 12 Months after vaccination 1 | 5872 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: before vaccination 1 | 1965 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: before vaccination 1 | 2241 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 6 Months after vaccination 1 | 10597 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:6 Months after vaccination 1 | 9495 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 1 Month after vaccination 1 | 25080 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 2 Months after vaccination 1 | 16797 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: before vaccination 1 | 1635 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:6 Months after vaccination 1 | 10578 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 1 Month after vaccination 1 | 24320 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:3 Months after vaccination 1 | 15291 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 12 Months after vaccination 1 | 7001 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 2 Months after vaccination 1 | 17706 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 3 Months after vaccination 1 | 15031 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 1 Month after vaccination 1 | 23510 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 6 Months after vaccination 1 | 10645 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: before vaccination 1 | 1793 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 12 Months after vaccination 1 | 6946 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 1 Month after vaccination 1 | 25815 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 12 Months after vaccination 1 | 8919 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 2 Months after vaccination 1 | 17410 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 2 Months after vaccination 1 | 17268 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:3 Months after vaccination 1 | 16265 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: before vaccination 1 | 2390 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 6 Months after vaccination 1 | 10875 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: before vaccination 1 | 2734 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 1 Month after vaccination 1 | 25719 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:6 Months after vaccination 1 | 11268 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 3 Months after vaccination 1 | 14645 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 12 Months after vaccination 1 | 8500 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 12 Months after vaccination 1 | 1931 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: before vaccination 1 | 1766 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 1 Month after vaccination 1 | 1664 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 2 Months after vaccination 1 | 1414 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 2 Months after vaccination 1 | 1413 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: 1 Month after vaccination 1 | 1697 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 3 Months after vaccination 1 | 1995 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:3 Months after vaccination 1 | 1772 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 12 Months after vaccination 1 | 2058 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A:6 Months after vaccination 1 | 2057 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV B: 6 Months after vaccination 1 | 2374 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) | RSV A: before vaccination 1 | 1585 Titers |
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.
Time frame: Before vaccination and 1 Month after SIIV vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | A-H3N2: before SIIV | 35.1 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 77.2 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | A-H1N1: before SIIV | 44.5 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 77.7 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | B1: before SIIV | 13.2 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | B1: 1 month after SIIV | 23.5 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | B2: before SIIV | 16.3 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | B2: 1 month after SIIV | 29.0 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B1: before SIIV | 10.3 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H3N2: before SIIV | 25.4 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H1N1: before SIIV | 25.0 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B2: before SIIV | 11.7 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 129.6 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B1: 1 month after SIIV | 41.7 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 95.3 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B2: 1 month after SIIV | 39.4 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 81.4 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | B1: 1 month after SIIV | 29.3 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | B2: 1 month after SIIV | 27.8 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 85.8 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | B2: before SIIV | 12.5 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | A-H1N1: before SIIV | 38.0 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | B1: before SIIV | 10.8 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | A-H3N2: before SIIV | 32.7 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 114.0 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B2: 1 month after SIIV | 46.9 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 158.8 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B1: before SIIV | 13.3 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B2: before SIIV | 18.4 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H3N2: before SIIV | 35.7 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B1: 1 month after SIIV | 47.2 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H1N1: before SIIV | 33.7 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | B1: before SIIV | 7.3 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 62.4 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | B2: 1 month after SIIV | 22.6 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | A-H3N2: before SIIV | 23.9 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | A-H1N1: before SIIV | 18.9 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | B2: before SIIV | 9.3 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 85.2 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | B1: 1 month after SIIV | 18.4 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 120.0 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H1N1: before SIIV | 27.0 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B1: 1 month after SIIV | 38.4 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B1: before SIIV | 13.0 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 113.5 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B2: before SIIV | 12.8 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B2: 1 month after SIIV | 28.4 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H3N2: before SIIV | 28.8 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | B2: before SIIV | 11.5 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | B1: before SIIV | 8.7 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 74.5 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | A-H1N1: before SIIV | 29.6 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 70.2 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | B1: 1 month after SIIV | 19.1 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | B2: 1 month after SIIV | 22.3 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | A-H3N2: before SIIV | 30.3 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: before SIIV | 26.1 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 128.8 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B2: 1 month after SIIV | 39.7 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: before SIIV | 25.7 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 130.6 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B1: before SIIV | 9.5 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B1: 1 month after SIIV | 32.7 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B2: before SIIV | 10.6 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | A-H1N1: before SIIV | 20.5 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | B1: 1 month after SIIV | 15.5 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | B2: before SIIV | 10.4 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 81.4 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | A-H3N2: before SIIV | 20.9 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | B1: before SIIV | 8.3 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 57.2 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | B2: 1 month after SIIV | 20.1 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | B2: before SIIV | 12.3 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 83.6 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: before SIIV | 22.4 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: before SIIV | 28.7 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | B1: 1 month after SIIV | 22.3 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | B1: before SIIV | 9.4 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 82.1 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | B2: 1 month after SIIV | 28.7 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | B1: 1 month after SIIV | 23.8 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 95.8 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | B2: 1 month after SIIV | 25.9 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | B2: before SIIV | 11.6 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | A-H3N2: before SIIV | 32.3 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 72.3 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | A-H1N1: before SIIV | 32.1 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | B1: before SIIV | 12.6 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B1: before SIIV | 9.2 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 134.8 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B1: 1 month after SIIV | 25.6 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B2: 1 month after SIIV | 37.5 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: before SIIV | 20.3 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B2: before SIIV | 11.2 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 114.4 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: before SIIV | 22.7 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | B2: 1 month after SIIV | 36.2 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | B2: before SIIV | 13.1 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: before SIIV | 34.4 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: before SIIV | 33.5 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | B1: before SIIV | 10.5 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | B1: 1 month after SIIV | 31.8 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 126.9 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 152.5 Titers |
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.
Time frame: Before vaccination and 1 Month after SIIV vaccination
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | A-H3N2: before SIIV | 29.7 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 43.6 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | A-H1N1: before SIIV | 13.8 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 94.3 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | B1: before SIIV | 9.4 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | B1: 1 month after SIIV | 19.5 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | B2: before SIIV | 7.7 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | B2: 1 month after SIIV | 10.4 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B1: before SIIV | 8.6 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H3N2: before SIIV | 24.7 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H1N1: before SIIV | 14.8 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B2: before SIIV | 7.7 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 105.6 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B1: 1 month after SIIV | 26.4 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 54.5 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B2: 1 month after SIIV | 11.0 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 78.2 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | B1: 1 month after SIIV | 22.9 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | B2: 1 month after SIIV | 13.0 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 44.4 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | B2: before SIIV | 9.6 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | A-H1N1: before SIIV | 11.0 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | B1: before SIIV | 12.9 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | A-H3N2: before SIIV | 26.2 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 61.9 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B2: 1 month after SIIV | 12.4 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 118.3 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B1: before SIIV | 8.5 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B2: before SIIV | 8.0 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H3N2: before SIIV | 22.9 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B1: 1 month after SIIV | 31.7 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H1N1: before SIIV | 13.4 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | B1: before SIIV | 11.1 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 52.9 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | B2: 1 month after SIIV | 16.6 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | A-H3N2: before SIIV | 34.6 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | A-H1N1: before SIIV | 16.6 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | B2: before SIIV | 10.6 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 140.0 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | B1: 1 month after SIIV | 24.7 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 109.3 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H1N1: before SIIV | 12.3 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B1: 1 month after SIIV | 23.4 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B1: before SIIV | 10.4 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 51.1 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B2: before SIIV | 8.2 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | B2: 1 month after SIIV | 13.2 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | A-H3N2: before SIIV | 23.5 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | B2: before SIIV | 9.9 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | B1: before SIIV | 11.5 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 131.5 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | A-H1N1: before SIIV | 17.5 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 56.6 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | B1: 1 month after SIIV | 26.2 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | B2: 1 month after SIIV | 13.3 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | A-H3N2: before SIIV | 30.5 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: before SIIV | 14.4 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 71.0 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B2: 1 month after SIIV | 10.0 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: before SIIV | 35.7 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 185.0 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B1: before SIIV | 8.7 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B1: 1 month after SIIV | 21.6 Titers |
| Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B2: before SIIV | 6.9 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | A-H1N1: before SIIV | 17.8 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | B1: 1 month after SIIV | 18.9 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | B2: before SIIV | 7.9 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 79.0 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | A-H3N2: before SIIV | 22.5 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | B1: before SIIV | 8.7 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 45.7 Titers |
| Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years | 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) | B2: 1 month after SIIV | 9.7 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | B2: before SIIV | 8.3 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 58.4 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: before SIIV | 32.6 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: before SIIV | 15.2 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | B1: 1 month after SIIV | 29.4 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | B1: before SIIV | 8.5 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 153.4 Titers |
| Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years | 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) | B2: 1 month after SIIV | 15.3 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | B1: 1 month after SIIV | 21.2 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 103.1 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | B2: 1 month after SIIV | 10.9 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | B2: before SIIV | 8.6 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | A-H3N2: before SIIV | 34.7 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 52.4 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | A-H1N1: before SIIV | 15.6 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years | 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) | B1: before SIIV | 9.5 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B1: before SIIV | 8.6 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 130.4 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B1: 1 month after SIIV | 23.1 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B2: 1 month after SIIV | 13.2 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: before SIIV | 44.5 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | B2: before SIIV | 8.4 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 72.0 Titers |
| Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: before SIIV | 22.5 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | B2: 1 month after SIIV | 13.2 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | B2: before SIIV | 7.3 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: before SIIV | 28.7 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: before SIIV | 17.6 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | B1: before SIIV | 9.1 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | B1: 1 month after SIIV | 26.8 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | A-H1N1: 1 month after SIIV | 75.8 Titers |
| Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years | 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) | A-H3N2: 1 month after SIIV | 106.4 Titers |
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.
Time frame: Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | RSV A:3 Months after vaccination 1 | 8258 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | RSV B: 2 Weeks after vaccination 1 | 23974 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | RSV B: 2 Months after vaccination 1 | 13959 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | RSV A:6 Months after vaccination 1 | 11466 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | RSV B: 12 Months after vaccination 1 | 4674 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | RSV B: 1 Month after vaccination 1 | 18932 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | RSV B: 6 Months after vaccination 1 | 15235 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | RSV A: 1 Month after vaccination 1 | 16730 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | RSV B: before vaccination 1 | 1427 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | RSV B: 3 Months after vaccination 1 | 9688 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | RSV A: 2 Months after vaccination 1 | 12702 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | RSV A: 2 Weeks after vaccination 1 | 20936 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | RSV A: before vaccination 1 | 1319 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | 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) | RSV A: 12 Months after vaccination 1 | 4430 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 2 Months after vaccination 1 | 28374 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A:3 Months after vaccination 1 | 15276 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: 1 Month after vaccination 1 | 20512 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 12 Months after vaccination 1 | 9274 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: before vaccination 1 | 2077 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: 12 Months after vaccination 1 | 11052 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 1 Month after vaccination 1 | 19197 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: before vaccination 1 | 1754 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A:6 Months after vaccination 1 | 22737 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 6 Months after vaccination 1 | 16492 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: 2 Months after vaccination 1 | 28577 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 3 Months after vaccination 1 | 12697 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: 2 Weeks after vaccination 1 | 24970 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 2 Weeks after vaccination 1 | 22491 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | RSV B: 2 Months after vaccination 1 | 8760 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | RSV A: 12 Months after vaccination 1 | 6147 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | RSV B: before vaccination 1 | 995 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | RSV A: 2 Weeks after vaccination 1 | 31584 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | RSV A: before vaccination 1 | 1090 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | RSV B: 6 Months after vaccination 1 | 10918 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | RSV A: 1 Month after vaccination 1 | 10021 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | RSV B: 3 Months after vaccination 1 | 8833 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | RSV A: 2 Months after vaccination 1 | 11171 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | RSV B: 12 Months after vaccination 1 | 4127 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | RSV A:3 Months after vaccination 1 | 10800 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | RSV B: 1 Month after vaccination 1 | 8510 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | RSV A:6 Months after vaccination 1 | 12034 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | 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) | RSV B: 2 Weeks after vaccination 1 | 32104 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 2 Months after vaccination 1 | 16167 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: before vaccination 1 | 1531 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: 2 Weeks after vaccination 1 | 31193 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: 1 Month after vaccination 1 | 16521 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: 2 Months after vaccination 1 | 15529 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A:3 Months after vaccination 1 | 12421 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A:6 Months after vaccination 1 | 9707 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: 12 Months after vaccination 1 | 5849 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: before vaccination 1 | 1670 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 2 Weeks after vaccination 1 | 42222 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 1 Month after vaccination 1 | 18080 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 3 Months after vaccination 1 | 11986 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 6 Months after vaccination 1 | 11658 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 12 Months after vaccination 1 | 5392 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | RSV A:3 Months after vaccination 1 | 19654 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | RSV A: 1 Month after vaccination 1 | 27892 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | RSV B: 2 Weeks after vaccination 1 | 59752 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | RSV A: 2 Months after vaccination 1 | 23033 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | RSV B: 2 Months after vaccination 1 | 19534 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | RSV A: 12 Months after vaccination 1 | 9851 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | RSV B: 6 Months after vaccination 1 | 11857 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | RSV A:6 Months after vaccination 1 | 13672 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | RSV A: 2 Weeks after vaccination 1 | 44866 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | RSV B: before vaccination 1 | 1600 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | RSV B: 3 Months after vaccination 1 | 16706 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | RSV B: 1 Month after vaccination 1 | 26759 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | RSV A: before vaccination 1 | 2029 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | 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) | RSV B: 12 Months after vaccination 1 | 8565 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 2 Weeks after vaccination 1 | 59955 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A:6 Months after vaccination 1 | 8237 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A:3 Months after vaccination 1 | 12922 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 1 Month after vaccination 1 | 29668 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: 2 Months after vaccination 1 | 18883 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 2 Months after vaccination 1 | 18280 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: 1 Month after vaccination 1 | 28453 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 3 Months after vaccination 1 | 11588 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: 2 Weeks after vaccination 1 | 52339 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 12 Months after vaccination 1 | 7373 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: 6 Months after vaccination 1 | 7435 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: 12 Months after vaccination 1 | 8707 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV A: before vaccination 1 | 1553 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | 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) | RSV B: before vaccination 1 | 1492 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | RSV A: 2 Weeks after vaccination 1 | 2817 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | RSV A: 12 Months after vaccination 1 | 2043 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | RSV A:3 Months after vaccination 1 | 1560 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | RSV A:6 Months after vaccination 1 | 2658 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | RSV B: 2 Weeks after vaccination 1 | 2817 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | RSV B: before vaccination 1 | 1393 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | RSV B: 2 Months after vaccination 1 | 1604 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | RSV A: 1 Month after vaccination 1 | 2430 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | RSV B: 6 Months after vaccination 1 | 2865 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | RSV A: 2 Months after vaccination 1 | 1851 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | RSV B: 1 Month after vaccination 1 | 1861 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | RSV B: 12 Months after vaccination 1 | 1970 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | RSV A: before vaccination 1 | 1229 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | 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) | RSV B: 3 Months after vaccination 1 | 1613 Titers |
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.
Time frame: Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: before vaccination 1 | 1904 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A:3 Months after vaccination 1 | 9792 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 12 Months after vaccination 1 | 9446 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 2 Weeks after vaccination 1 | 17464 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 12 Months after vaccination 1 | 9721 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A:6 Months after vaccination 1 | 12290 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 6 Months after vaccination 1 | 16998 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 1 Month after vaccination 1 | 27789 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 2 Months after vaccination 1 | 15025 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 3 Months after vaccination 1 | 12225 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 2 Months after vaccination 1 | 19061 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 2 Weeks after vaccination 1 | 27923 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: before vaccination 1 | 2573 Titers |
| Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 1 Month after vaccination 1 | 21116 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 12 Months after vaccination 1 | 7507 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: before vaccination 1 | 1672 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 1 Month after vaccination 1 | 21429 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 12 Months after vaccination 1 | 5801 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 2 Months after vaccination 1 | 10949 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 1 Month after vaccination 1 | 21788 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A:6 Months after vaccination 1 | 10213 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: before vaccination 1 | 1139 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 2 Weeks after vaccination 1 | 22594 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 6 Months after vaccination 1 | 11281 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 2 Months after vaccination 1 | 10713 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 3 Months after vaccination 1 | 10364 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 2 Weeks after vaccination 1 | 19751 Titers |
| Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A:3 Months after vaccination 1 | 12202 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 12 Months after vaccination 1 | 8484 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 1 Month after vaccination 1 | 23161 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 2 Months after vaccination 1 | 16441 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 2 Weeks after vaccination 1 | 25820 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: before vaccination 1 | 1190 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 6 Months after vaccination 1 | 8636 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 1 Month after vaccination 1 | 16610 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 3 Months after vaccination 1 | 7190 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 2 Months after vaccination 1 | 11284 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 12 Months after vaccination 1 | 6174 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: before vaccination 1 | 2056 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A:6 Months after vaccination 1 | 12795 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 2 Weeks after vaccination 1 | 31946 Titers |
| Sentinel Cohort: RSV 120 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A:3 Months after vaccination 1 | 11476 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 12 Months after vaccination 1 | 10709 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: before vaccination 1 | 1568 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 2 Weeks after vaccination 1 | 33779 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 1 Month after vaccination 1 | 19632 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 2 Months after vaccination 1 | 9247 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: before vaccination 1 | 1923 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 2 Weeks after vaccination 1 | 30618 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 1 Month after vaccination 1 | 20499 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 2 Months after vaccination 1 | 10493 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A:3 Months after vaccination 1 | 11561 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A:6 Months after vaccination 1 | 12172 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 3 Months after vaccination 1 | 11138 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 6 Months after vaccination 1 | 12541 Titers |
| Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 12 Months after vaccination 1 | 8589 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: before vaccination 1 | 1923 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 1 Month after vaccination 1 | 32668 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A:3 Months after vaccination 1 | 11195 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 2 Months after vaccination 1 | 15567 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 12 Months after vaccination 1 | 2705 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 1 Month after vaccination 1 | 24481 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 6 Months after vaccination 1 | 6949 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 2 Weeks after vaccination 1 | 29812 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 2 Weeks after vaccination 1 | 47514 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 2 Months after vaccination 1 | 12659 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 3 Months after vaccination 1 | 12998 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A:6 Months after vaccination 1 | 7083 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: before vaccination 1 | 2144 Titers |
| Sentinel Cohort: RSV 240 mcg Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 12 Months after vaccination 1 | 3230 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A:3 Months after vaccination 1 | 12747 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 2 Weeks after vaccination 1 | 40272 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: before vaccination 1 | 1564 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A:6 Months after vaccination 1 | 9417 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 2 Months after vaccination 1 | 12441 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 12 Months after vaccination 1 | 4145 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 1 Month after vaccination 1 | 37852 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 3 Months after vaccination 1 | 11726 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 2 Weeks after vaccination 1 | 41776 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 12 Months after vaccination 1 | 2918 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 6 Months after vaccination 1 | 8066 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 1 Month after vaccination 1 | 36197 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: before vaccination 1 | 1417 Titers |
| Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 2 Months after vaccination 1 | 13723 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 2 Weeks after vaccination 1 | 2441 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 1 Month after vaccination 1 | 2675 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: before vaccination 1 | 2359 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 2 Weeks after vaccination 1 | 2233 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A:3 Months after vaccination 1 | 1543 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 2 Months after vaccination 1 | 1502 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A: 12 Months after vaccination 1 | 2341 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 1 Month after vaccination 1 | 3104 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 6 Months after vaccination 1 | 1920 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 2 Months after vaccination 1 | 1461 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV A:6 Months after vaccination 1 | 1945 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 12 Months after vaccination 1 | 2188 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: before vaccination 1 | 2285 Titers |
| Sentinel Cohort: Placebo Age 18-49 Years | Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) | RSV B: 3 Months after vaccination 1 | 1436 Titers |