CompletedNCT03529773Updated Mar 3, 2022Results posted

A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults

A Phase 2 interventional study of Formulation A and Formulation B in Respiratory Tract Infections, sponsored by Pfizer. Completed at 40 sites in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-03.

Sponsored by Pfizer · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 1,235
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study 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).

Read the detailed description

The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with SIIV. Healthy male and female subjects divided into 2 age groups (18-49 years of age and 50-85 years of age in the sentinel cohort and 18-49 years of age and 65-85 years of age in the expanded cohort) will be enrolled. Age groups will run in parallel. Subjects in the sentinel cohort in each age group will receive one of two RSV vaccine formulations at one of 3 antigen dose levels or placebo. Subjects in the expanded cohort in each age group will receive one of two RSV vaccine formulations at one of 3 antigen dose levels with and without SIIV.

Conditions studied

Respiratory Tract Infections

Browse trials for

Respiratory Tract Infections 1,031

Keywords

Respiratory tract infections, RSV, vaccine

In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

This study's enrollment of 1,235 is above the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
Healthy adults who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures.
Male subject who is able to father children and willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product; female subject who is of childbearing potential and at risk for pregnancy and who is willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product; male subject not able to father children; female subject not of childbearing potential.
Sentinel-cohort subjects only: Male and female adults aged 18 to 85 years at the time of enrollment (signing of the ICD).
Expanded-cohort subjects only: Male and female adults aged 18 to 49 years of age or 65 to 85 years at the time of enrollment (signing of the ICD).

Exclusion criteria

Exclusion Criteria:

Sentinel-cohort subjects only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
Sentinel-cohort subjects only: Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit.
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.
Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt throughout the study of nonstudy RSV vaccine.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product(s).
Immunocompromised subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Subjects who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (\<14 days) for treatment of an acute illness, subjects should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before investigational product administration. Intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
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).
Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Women who are pregnant or breastfeeding.
Expanded-cohort subjects only: Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
Expanded-cohort subjects only: Allergy to egg proteins (egg or egg products) or chicken proteins.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 1,235 participants (actual)

Study arms

Experimental
Sentinel Arm 1
Low dose formulation A
Biological: Formulation A
Experimental
Sentinel Arm 2
Mid dose formulation A
Biological: Formulation A
Experimental
Sentinel Arm 3
High dose formulation A
Biological: Formulation A
Experimental
Sentinel Arm 4
Low dose formulation B
Biological: Formulation B
Experimental
Sentinel Arm 5
Mid dose formulation B
Biological: Formulation B
Experimental
Sentinel Arm 6
High dose formulation B
Biological: Formulation B
Placebo comparator
Sentinel Arm 7
Placebo
Biological: Placebo
Experimental
Expanded Arm 8
Low dose formulation A and SIIV
Biological: Formulation A
Experimental
Expanded Arm 9
Mid dose formulation A and SIIV
Biological: Formulation A
Experimental
Expanded Arm 10
High dose formulation A and SIIV
Biological: Formulation A
Experimental
Expanded Arm 11
Low dose formulation B and SIIV
Biological: Formulation B
Experimental
Expanded Arm 12
Mid dose formulation B and SIIV
Biological: Formulation B
Experimental
Expanded Arm 13
High dose formulation B and SIIV
Biological: Formulation B
Experimental
Expanded Arm 14
Low dose formulation A and placebo
Biological: Formulation A
Experimental
Expanded Arm 15
Mid dose formulation A and placebo
Biological: Formulation A
Experimental
Expanded Arm 16
High dose formulation A and placebo
Biological: Formulation A
Experimental
Expanded Arm 17
Low dose formulation B and placebo
Biological: Formulation B
Experimental
Expanded Arm 18
Mid dose formulation B and placebo
Biological: Formulation B
Experimental
Expanded Arm 19
High dose formulation B and placebo
Biological: Formulation B
Placebo comparator
Expanded Arm 20
placebo and placebo
Biological: Placebo

Interventions

BiologicalFormulation A
RSV vaccine
BiologicalFormulation B
RSV vaccine
BiologicalPlacebo
Placebo

What researchers measure

Primary outcomes

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
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
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
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
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
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Secondary outcomes

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
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
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
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
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
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

Results

Posted Mar 4, 2021

Participant flow

Participant flow — Overall Study
Milestone	Sentinel Cohort: Respiratory Syncytial Virus (RSV) Vaccine 60 Microgram (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 and SIIV 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
Started	12	12	12	12	12	12	12	12	12	12	12	12	12	12	41	42	41	41	41	41	41	41	41	41	41	41	41	41	41	40	42	40	40	41	41	40	41	42	43	41
Completed	12	12	11	12	11	11	12	11	12	11	11	12	10	11	35	38	40	35	37	37	34	36	34	35	33	30	32	39	40	40	39	40	40	39	37	36	39	36	39	37
Not completed	0	0	1	0	1	1	0	1	0	1	1	0	2	1	6	4	1	6	4	4	7	5	7	6	8	11	9	2	1	0	3	0	0	2	4	4	2	6	4	4
Withdrew: 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
Withdrew: 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
Withdrew: 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
Withdrew: 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
Withdrew: 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
Withdrew: 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
Withdrew: 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
Withdrew: 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
Withdrew: 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
Withdrew: 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

Outcome measures

PrimarySentinel 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
Reported as:: Number · Percentage of participants

Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination
Percentage of participants	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
Pain at injection site: mild	50.0 (21.1 to 78.9)	58.3 (27.7 to 84.8)	25.0 (5.5 to 57.2)	75.0 (42.8 to 94.5)	0 (0.0 to 28.5)	58.3 (27.7 to 84.8)	16.7 (2.1 to 48.4)
Pain at injection site: moderate	0 (0.0 to 26.5)	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	18.2 (2.3 to 51.8)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Pain at injection site: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Redness: mild	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Redness: moderate	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Redness: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Swelling: mild	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Swelling: moderate	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 28.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Swelling: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)

PrimarySentinel 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
Reported as:: Number · Percentage of participants

Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination
Percentage of participants	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
Pain at injection site: mild	16.7 (2.1 to 48.4)	16.7 (2.1 to 48.4)	8.3 (0.2 to 38.5)	16.7 (2.1 to 48.4)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Pain at injection site: moderate	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	25.0 (5.5 to 57.2)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Pain at injection site: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Redness: mild	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Redness: moderate	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Redness: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Swelling: mild	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Swelling: moderate	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Swelling: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)

PrimaryExpanded 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
Reported as:: Number · Percentage of participants

Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1
Percentage of participants	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 and SIIV 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
Pain at injection site: mild	34.1 (20.1 to 50.6)	31.0 (17.6 to 47.1)	41.5 (26.3 to 57.9)	32.5 (18.6 to 49.1)	36.6 (22.1 to 53.1)	43.9 (28.5 to 60.3)	48.8 (32.9 to 64.9)	55.0 (38.5 to 70.7)	24.4 (12.4 to 40.3)	34.1 (20.1 to 50.6)	51.2 (35.1 to 67.1)	48.8 (32.9 to 64.9)	14.6 (5.6 to 29.2)
Pain at injection site: moderate	12.2 (4.1 to 26.2)	7.1 (1.5 to 19.5)	26.8 (14.2 to 42.9)	20.0 (9.1 to 35.6)	9.8 (2.7 to 23.1)	7.3 (1.5 to 19.9)	12.2 (4.1 to 26.2)	12.5 (4.2 to 26.8)	14.6 (5.6 to 29.2)	7.3 (1.5 to 19.9)	9.8 (2.7 to 23.1)	17.1 (7.2 to 32.1)	2.4 (0.1 to 12.9)
Pain at injection site: severe	0 (0.0 to 8.6)	0 (0.0 to 8.4)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)
Redness: mild	2.4 (0.1 to 12.9)	4.8 (0.6 to 16.2)	0 (0.0 to 8.6)	2.5 (0.1 to 13.2)	0 (0.0 to 8.6)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	7.5 (1.6 to 20.4)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)	7.3 (1.5 to 19.9)	4.9 (0.6 to 16.5)	2.4 (0.1 to 12.9)
Redness: moderate	0 (0.0 to 8.6)	2.4 (0.1 to 12.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	0 (0.0 to 8.8)	4.9 (0.6 to 16.5)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)	9.8 (2.7 to 23.1)	0 (0.0 to 8.6)
Redness: severe	0 (0.0 to 8.6)	0 (0.0 to 8.4)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)
Swelling: mild	2.4 (0.1 to 12.9)	4.8 (0.6 to 16.2)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	9.8 (2.7 to 23.1)	2.4 (0.1 to 12.9)	5.0 (0.6 to 16.9)	4.9 (0.6 to 16.5)	0 (0.0 to 8.6)	4.9 (0.6 to 16.5)	9.8 (2.7 to 23.1)	0 (0.0 to 8.6)
Swelling: moderate	2.4 (0.1 to 12.9)	4.8 (0.6 to 16.2)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	7.3 (1.5 to 19.9)	4.9 (0.6 to 16.5)	2.4 (0.1 to 12.9)	9.8 (2.7 to 23.1)	0 (0.0 to 8.6)
Swelling: severe	0 (0.0 to 8.6)	0 (0.0 to 8.4)	0 (0.0 to 8.6)	2.5 (0.1 to 13.2)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)

PrimaryExpanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1

Time frame:: Within 14 days after vaccination 1 on Day 1
Reported as:: Number · Percentage of participants

Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1
Percentage of participants	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
Pain at injection site: mild	25.0 (12.7 to 41.2)	10.0 (2.8 to 23.7)	22.5 (10.8 to 38.5)	23.8 (12.1 to 39.5)	22.5 (10.8 to 38.5)	10.0 (2.8 to 23.7)	26.8 (14.2 to 42.9)	19.5 (8.8 to 34.9)	32.5 (18.6 to 49.1)	19.5 (8.8 to 34.9)	19.0 (8.6 to 34.1)	14.0 (5.3 to 27.9)	5.0 (0.6 to 16.9)
Pain at injection site: moderate	2.5 (0.1 to 13.2)	0 (0.0 to 8.8)	5.0 (0.6 to 16.9)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	2.5 (0.1 to 13.2)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	4.8 (0.6 to 16.2)	4.7 (0.6 to 15.8)	0 (0.0 to 8.8)
Pain at injection site: severe	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.4)	0 (0.0 to 8.2)	0 (0.0 to 8.8)
Redness: mild	2.5 (0.1 to 13.2)	2.5 (0.1 to 13.2)	0 (0.0 to 8.8)	7.1 (1.5 to 19.5)	2.5 (0.1 to 13.2)	7.5 (1.6 to 20.4)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	0 (0.0 to 8.8)	7.3 (1.5 to 19.9)	0 (0.0 to 8.4)	4.7 (0.6 to 15.8)	0 (0.0 to 8.8)
Redness: moderate	5.0 (0.6 to 16.9)	2.5 (0.1 to 13.2)	2.5 (0.1 to 13.2)	2.4 (0.1 to 12.6)	5.0 (0.6 to 16.9)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)	2.5 (0.1 to 13.2)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.6)	2.3 (0.1 to 12.3)	0 (0.0 to 8.8)
Redness: severe	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	0 (0.0 to 8.4)	0 (0.0 to 8.2)	0 (0.0 to 8.8)
Swelling: mild	7.5 (1.6 to 20.4)	5.0 (0.6 to 16.9)	0 (0.0 to 8.8)	4.8 (0.6 to 16.2)	2.5 (0.1 to 13.2)	5.0 (0.6 to 16.9)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	5.0 (0.6 to 16.9)	0 (0.0 to 8.6)	2.4 (0.1 to 12.6)	2.3 (0.1 to 12.3)	2.5 (0.1 to 13.2)
Swelling: moderate	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	5.0 (0.6 to 16.9)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.6)	2.3 (0.1 to 12.3)	0 (0.0 to 8.8)
Swelling: severe	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	0 (0.0 to 8.4)	2.3 (0.1 to 12.3)	0 (0.0 to 8.8)

PrimarySentinel 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
Reported as:: Number · Percentage of participants

Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination
Percentage of participants	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
Fever: >=38.0 degree C	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Fever: mild	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Fever: moderate	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Fever: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Fever: Grade 4	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Fatigue: mild	8.3 (0.2 to 38.5)	41.7 (15.2 to 72.3)	16.7 (2.1 to 48.4)	33.3 (9.9 to 65.1)	9.1 (0.2 to 41.3)	16.7 (2.1 to 48.4)	25.0 (5.5 to 57.2)
Fatigue: moderate	25.0 (5.5 to 57.2)	8.3 (0.2 to 38.5)	25.0 (5.5 to 57.2)	25.0 (5.5 to 57.2)	36.4 (10.9 to 69.2)	33.3 (9.9 to 65.1)	0 (0.0 to 26.5)
Fatigue: severe	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	9.1 (0.2 to 41.3)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Headache: mild	16.7 (2.1 to 48.4)	16.7 (2.1 to 48.4)	8.3 (0.2 to 38.5)	33.3 (9.9 to 65.1)	27.3 (6.0 to 61.0)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)
Headache: moderate	25.0 (5.5 to 57.2)	25.0 (5.5 to 57.2)	16.7 (2.1 to 48.4)	8.3 (0.2 to 38.5)	27.3 (6.0 to 61.0)	33.3 (9.9 to 65.1)	0 (0.0 to 26.5)
Headache: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	9.1 (0.2 to 41.3)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Nausea: mild	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	16.7 (2.1 to 48.4)	0 (0.0 to 28.5)	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)
Nausea: moderate	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	18.2 (2.3 to 51.8)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Nausea: severe	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Muscle pain: mild	50.0 (21.1 to 78.9)	25.0 (5.5 to 57.2)	25.0 (5.5 to 57.2)	33.3 (9.9 to 65.1)	0 (0.0 to 28.5)	41.7 (15.2 to 72.3)	8.3 (0.2 to 38.5)
Muscle pain: moderate	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)	16.7 (2.1 to 48.4)	9.1 (0.2 to 41.3)	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)
Muscle pain: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	9.1 (0.2 to 41.3)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Joint pain: mild	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	16.7 (2.1 to 48.4)	0 (0.0 to 28.5)	16.7 (2.1 to 48.4)	8.3 (0.2 to 38.5)
Joint pain: moderate	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)	9.1 (0.2 to 41.3)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Joint pain: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	9.1 (0.2 to 41.3)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Vomiting: mild	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	18.2 (2.3 to 51.8)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Vomiting: moderate	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Vomiting: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Diarrhea: mild	0 (0.0 to 26.5)	16.7 (2.1 to 48.4)	16.7 (2.1 to 48.4)	8.3 (0.2 to 38.5)	27.3 (6.0 to 61.0)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Diarrhea: moderate	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)	0.0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)
Diarrhea: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 28.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)

PrimarySentinel 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
Reported as:: Number · Percentage of participants

Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination
Percentage of participants	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
Fever: >=38.0 degree C	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Fever: mild	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Fever: moderate	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Fever: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Fever: Grade 4	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Fatigue: mild	41.7 (15.2 to 72.3)	16.7 (2.1 to 48.4)	33.3 (9.9 to 65.1)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	16.7 (2.1 to 48.4)	16.7 (2.1 to 48.4)
Fatigue: moderate	0 (0.0 to 26.5)	33.3 (9.9 to 65.1)	0 (0.0 to 26.5)	25.0 (5.5 to 57.2)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)	16.7 (2.1 to 48.4)
Fatigue: severe	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Headache: mild	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)	25.0 (5.5 to 57.2)	16.7 (2.1 to 48.4)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Headache: moderate	8.3 (0.2 to 38.5)	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)
Headache: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Nausea: mild	16.7 (2.1 to 48.4)	8.3 (0.2 to 38.5)	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Nausea: moderate	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Nausea: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Muscle pain: mild	33.3 (9.9 to 65.1)	33.3 (9.9 to 65.1)	8.3 (0.2 to 38.5)	25.0 (5.5 to 57.2)	8.3 (0.2 to 38.5)	25.0 (5.5 to 57.2)	0 (0.0 to 26.5)
Muscle pain:moderate	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	25.0 (5.5 to 57.2)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)
Muscle pain: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Joint pain: mild	8.3 (0.2 to 38.5)	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)	16.7 (2.1 to 48.4)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Joint pain: moderate	8.3 (0.2 to 38.5)	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)
Joint pain: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Vomiting: mild	0 (0.0 to 26.5)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Vomiting: moderate	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Vomiting: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)
Diarrhea: mild	0 (0.0 to 26.5)	0 (0.0 to 26.5)	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)	25.0 (5.5 to 57.2)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)
Diarrhea: moderate	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)
Diarrhea: severe	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)

PrimaryExpanded 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
Reported as:: Number · Percentage of participants

Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1
Percentage of participants	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 and SIIV 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
Fever: >=38.0 degree C	0 (0.0 to 8.6)	0 (0.0 to 8.4)	2.4 (0.1 to 12.9)	2.5 (0.1 to 13.2)	12.2 (4.1 to 26.2)	4.9 (0.6 to 16.5)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)
Fever: mild	0 (0.0 to 8.6)	0 (0.0 to 8.4)	0 (0.0 to 8.6)	2.5 (0.1 to 13.2)	4.9 (0.6 to 16.5)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)
Fever: moderate	0 (0.0 to 8.6)	0 (0.0 to 8.4)	2.4 (0.1 to 12.9)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)
Fever: severe	0 (0.0 to 8.6)	0 (0.0 to 8.4)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	4.9 (0.6 to 16.5)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)
Fever: Grade 4	0 (0.0 to 8.6)	0 (0.0 to 8.4)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)
Fatigue: mild	14.6 (5.6 to 29.2)	16.7 (7.0 to 31.4)	17.1 (7.2 to 32.1)	17.5 (7.3 to 32.8)	17.1 (7.2 to 32.1)	9.8 (2.7 to 23.1)	29.3 (16.1 to 45.5)	27.5 (14.6 to 43.9)	14.6 (5.6 to 29.2)	14.6 (5.6 to 29.2)	29.3 (16.1 to 45.5)	19.5 (8.8 to 34.9)	12.2 (4.1 to 26.2)
Fatigue: moderate	31.7 (18.1 to 48.1)	28.6 (15.7 to 44.6)	24.4 (12.4 to 40.3)	22.5 (10.8 to 38.5)	19.5 (8.8 to 34.9)	26.8 (14.2 to 42.9)	14.6 (5.6 to 29.2)	22.5 (10.8 to 38.5)	29.3 (16.1 to 45.5)	39.0 (24.2 to 55.5)	19.5 (8.8 to 34.9)	22.0 (10.6 to 37.6)	19.5 (8.8 to 34.9)
Fatigue: severe	2.4 (0.1 to 12.9)	0 (0.0 to 8.4)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)
Headache: mild	12.2 (4.1 to 26.2)	28.6 (15.7 to 44.6)	19.5 (8.8 to 34.9)	32.5 (18.6 to 49.1)	29.3 (16.1 to 45.5)	17.1 (7.2 to 32.1)	29.3 (16.1 to 45.5)	27.5 (14.6 to 43.9)	19.5 (8.8 to 34.9)	7.3 (1.5 to 19.9)	26.8 (14.2 to 42.9)	24.4 (12.4 to 40.3)	19.5 (8.8 to 34.9)
Headache: moderate	29.3 (16.1 to 45.5)	21.4 (10.3 to 36.8)	19.5 (8.8 to 34.9)	10.0 (2.8 to 23.7)	19.5 (8.8 to 34.9)	24.4 (12.4 to 40.3)	17.1 (7.2 to 32.1)	20.0 (9.1 to 35.6)	29.3 (16.1 to 45.5)	29.3 (16.1 to 45.5)	17.1 (7.2 to 32.1)	14.6 (5.6 to 29.2)	12.2 (4.1 to 26.2)
Headache: severe	2.4 (0.1 to 12.9)	4.8 (0.6 to 16.2)	0 (0.0 to 8.6)	2.5 (0.1 to 13.2)	2.4 (0.1 to 12.9)	7.3 (1.5 to 19.9)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)
Nausea: mild	4.9 (0.6 to 16.5)	7.1 (1.5 to 19.5)	12.2 (4.1 to 26.2)	12.5 (4.2 to 26.8)	9.8 (2.7 to 23.1)	19.5 (8.8 to 34.9)	7.3 (1.5 to 19.9)	7.5 (1.6 to 20.4)	14.6 (5.6 to 29.2)	14.6 (5.6 to 29.2)	2.4 (0.1 to 12.9)	9.8 (2.7 to 23.1)	9.8 (2.7 to 23.1)
Nausea: moderate	9.8 (2.7 to 23.1)	7.1 (1.5 to 19.5)	7.3 (1.5 to 19.9)	2.5 (0.1 to 13.2)	4.9 (0.6 to 16.5)	7.3 (1.5 to 19.9)	4.9 (0.6 to 16.5)	12.5 (4.2 to 26.8)	4.9 (0.6 to 16.5)	0 (0.0 to 8.6)	7.3 (1.5 to 19.9)	7.3 (1.5 to 19.9)	4.9 (0.6 to 16.5)
Nausea: severe	0 (0.0 to 8.6)	0 (0.0 to 8.4)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	2.5 (0.1 to 13.2)	0 (0.0 to 8.6)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)
Muscle pain: mild	24.4 (12.4 to 40.3)	16.7 (7.0 to 31.4)	34.1 (20.1 to 50.6)	27.5 (14.6 to 43.9)	29.3 (16.1 to 45.5)	22.0 (10.6 to 37.6)	43.9 (28.5 to 60.3)	37.5 (22.7 to 54.2)	19.5 (8.8 to 34.9)	24.4 (12.4 to 40.3)	36.6 (22.1 to 53.1)	26.8 (14.2 to 42.9)	12.2 (4.1 to 26.2)
Muscle pain: moderate	14.6 (5.6 to 29.2)	14.3 (5.4 to 28.5)	22.0 (10.6 to 37.6)	10.0 (2.8 to 23.7)	4.9 (0.6 to 16.5)	19.5 (8.8 to 34.9)	17.1 (7.2 to 32.1)	12.5 (4.2 to 26.8)	19.5 (8.8 to 34.9)	12.2 (4.1 to 26.2)	7.3 (1.5 to 19.9)	19.5 (8.8 to 34.9)	0 (0.0 to 8.6)
Muscle pain: severe	2.4 (0.1 to 12.9)	0 (0.0 to 8.4)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	2.5 (0.1 to 13.2)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)	4.9 (0.6 to 16.5)	4.9 (0.6 to 16.5)	0 (0.0 to 8.6)
Joint pain: mild	12.2 (4.1 to 26.2)	4.8 (0.6 to 16.2)	14.6 (5.6 to 29.2)	2.5 (0.1 to 13.2)	12.2 (4.1 to 26.2)	4.9 (0.6 to 16.5)	14.6 (5.6 to 29.2)	12.5 (4.2 to 26.8)	7.3 (1.5 to 19.9)	4.9 (0.6 to 16.5)	9.8 (2.7 to 23.1)	7.3 (1.5 to 19.9)	4.9 (0.6 to 16.5)
Joint pain: moderate	7.3 (1.5 to 19.9)	7.1 (1.5 to 19.5)	9.8 (2.7 to 23.1)	2.5 (0.1 to 13.2)	7.3 (1.5 to 19.9)	7.3 (1.5 to 19.9)	9.8 (2.7 to 23.1)	17.5 (7.3 to 32.8)	9.8 (2.7 to 23.1)	12.2 (4.1 to 26.2)	7.3 (1.5 to 19.9)	9.8 (2.7 to 23.1)	0 (0.0 to 8.6)
Joint pain: severe	0 (0.0 to 8.6)	0 (0.0 to 8.4)	2.4 (0.1 to 12.9)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)
Vomiting: mild	2.4 (0.1 to 12.9)	0 (0.0 to 8.4)	0 (0.0 to 8.6)	2.5 (0.1 to 13.2)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	0 (0.0 to 8.6)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)
Vomiting: moderate	0 (0.0 to 8.6)	0 (0.0 to 8.4)	2.4 (0.1 to 12.9)	0 (0.0 to 8.8)	4.9 (0.6 to 16.5)	0 (0.0 to 8.6)	2.4 (0.1 to 12.9)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	4.9 (0.6 to 16.5)	0 (0.0 to 8.6)
Vomiting: severe	0 (0.0 to 8.6)	0 (0.0 to 8.4)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	2.5 (0.1 to 13.2)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)
Diarrhea: mild	7.3 (1.5 to 19.9)	11.9 (4.0 to 25.6)	19.5 (8.8 to 34.9)	12.5 (4.2 to 26.8)	22.0 (10.6 to 37.6)	17.1 (7.2 to 32.1)	19.5 (8.8 to 34.9)	22.5 (10.8 to 38.5)	12.2 (4.1 to 26.2)	19.5 (8.8 to 34.9)	7.3 (1.5 to 19.9)	17.1 (7.2 to 32.1)	9.8 (2.7 to 23.1)
Diarrhea: moderate	7.3 (1.5 to 19.9)	11.9 (4.0 to 25.6)	4.9 (0.6 to 16.5)	2.5 (0.1 to 13.2)	2.4 (0.1 to 12.9)	7.3 (1.5 to 19.9)	0 (0.0 to 8.6)	2.5 (0.1 to 13.2)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	4.9 (0.6 to 16.5)	7.3 (1.5 to 19.9)	2.4 (0.1 to 12.9)
Diarrhea: severe	0 (0.0 to 8.6)	0 (0.0 to 8.4)	0 (0.0 to 8.6)	2.5 (0.1 to 13.2)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.6)

PrimaryExpanded 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
Reported as:: Number · Percentage of participants

Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1
Percentage of participants	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
Fever: >=38.0 degree C	0 (0.0 to 8.8)	2.5 (0.1 to 13.2)	2.5 (0.1 to 13.2)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	2.5 (0.1 to 13.2)	2.4 (0.1 to 12.9)	4.8 (0.6 to 16.2)	4.7 (0.6 to 15.8)	0 (0.0 to 8.8)
Fever: mild	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	4.8 (0.6 to 16.2)	2.3 (0.1 to 12.3)	0 (0.0 to 8.8)
Fever: moderate	0 (0.0 to 8.8)	0 (0.0 to 8.8)	2.5 (0.1 to 13.2)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	2.5 (0.1 to 13.2)	0 (0.0 to 8.6)	0 (0.0 to 8.4)	2.3 (0.1 to 12.3)	0 (0.0 to 8.8)
Fever: severe	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.4)	0 (0.0 to 8.2)	0 (0.0 to 8.8)
Fever: Grade 4	0 (0.0 to 8.8)	2.5 (0.1 to 13.2)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	0 (0.0 to 8.4)	0 (0.0 to 8.2)	0 (0.0 to 8.8)
Fatigue: mild	7.5 (1.6 to 20.4)	12.5 (4.2 to 26.8)	12.5 (4.2 to 26.8)	26.2 (13.9 to 42.0)	10.0 (2.8 to 23.7)	7.5 (1.6 to 20.4)	14.6 (5.6 to 29.2)	14.6 (5.6 to 29.2)	22.5 (10.8 to 38.5)	19.5 (8.8 to 34.9)	23.8 (12.1 to 39.5)	20.9 (10.0 to 36.0)	7.5 (1.6 to 20.4)
Fatigue: moderate	12.5 (4.2 to 26.8)	10.0 (2.8 to 23.7)	15.0 (5.7 to 29.8)	11.9 (4.0 to 25.6)	12.5 (4.2 to 26.8)	10.0 (2.8 to 23.7)	19.5 (8.8 to 34.9)	14.6 (5.6 to 29.2)	20.0 (9.1 to 35.6)	4.9 (0.6 to 16.5)	21.4 (10.3 to 36.8)	4.7 (0.6 to 15.8)	7.5 (1.6 to 20.4)
Fatigue: severe	0 (0.0 to 8.8)	2.5 (0.1 to 13.2)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	2.5 (0.1 to 13.2)	0 (0.0 to 8.6)	2.4 (0.1 to 12.9)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.6)	0 (0.0 to 8.2)	0 (0.0 to 8.8)
Headache: mild	17.5 (7.3 to 32.8)	7.5 (1.6 to 20.4)	7.5 (1.6 to 20.4)	14.3 (5.4 to 28.5)	15.0 (5.7 to 29.8)	12.5 (4.2 to 26.8)	7.3 (1.5 to 19.9)	22.0 (10.6 to 37.6)	10.0 (2.8 to 23.7)	24.4 (12.4 to 40.3)	21.4 (10.3 to 36.8)	9.3 (2.6 to 22.1)	20.0 (9.1 to 35.6)
Headache: moderate	7.5 (1.6 to 20.4)	5.0 (0.6 to 16.9)	5.0 (0.6 to 16.9)	2.4 (0.1 to 12.6)	2.5 (0.1 to 13.2)	5.0 (0.6 to 16.9)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	5.0 (0.6 to 16.9)	2.4 (0.1 to 12.9)	11.9 (4.0 to 25.6)	11.6 (3.9 to 25.1)	2.5 (0.1 to 13.2)
Headache: severe	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	0 (0.0 to 8.4)	0 (0.0 to 8.2)	0 (0.0 to 8.8)
Nausea: mild	5.0 (0.6 to 16.9)	7.5 (1.6 to 20.4)	2.5 (0.1 to 13.2)	0 (0.0 to 8.4)	5.0 (0.6 to 16.9)	5.0 (0.6 to 16.9)	7.3 (1.5 to 19.9)	4.9 (0.6 to 16.5)	7.5 (1.6 to 20.4)	9.8 (2.7 to 23.1)	2.4 (0.1 to 12.6)	2.3 (0.1 to 12.3)	5.0 (0.6 to 16.9)
Nausea: moderate	0 (0.0 to 8.8)	2.5 (0.1 to 13.2)	0 (0.0 to 8.8)	2.4 (0.1 to 12.6)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	14.6 (5.6 to 29.2)	5.0 (0.6 to 16.9)	0 (0.0 to 8.6)	4.8 (0.6 to 16.2)	2.3 (0.1 to 12.3)	0 (0.0 to 8.8)
Nausea: severe	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	0 (0.0 to 8.4)	0 (0.0 to 8.2)	0 (0.0 to 8.8)
Muscle pain: mild	15.0 (5.7 to 29.8)	7.5 (1.6 to 20.4)	10.0 (2.8 to 23.7)	14.3 (5.4 to 28.5)	15.0 (5.7 to 29.8)	5.0 (0.6 to 16.9)	14.6 (5.6 to 29.2)	19.5 (8.8 to 34.9)	17.5 (7.3 to 32.8)	17.1 (7.2 to 32.1)	19.0 (8.6 to 34.1)	4.7 (0.6 to 15.8)	7.5 (1.6 to 20.4)
Muscle pain: moderate	2.5 (0.1 to 13.2)	7.5 (1.6 to 20.4)	5.0 (0.6 to 16.9)	2.4 (0.1 to 12.6)	7.5 (1.6 to 20.4)	7.5 (1.6 to 20.4)	4.9 (0.6 to 16.5)	4.9 (0.6 to 16.5)	15.0 (5.7 to 29.8)	9.8 (2.7 to 23.1)	16.7 (7.0 to 31.4)	16.3 (6.8 to 30.7)	0 (0.0 to 8.8)
Muscle pain: severe	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	2.4 (0.1 to 12.9)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	0 (0.0 to 8.4)	0 (0.0 to 8.2)	2.5 (0.1 to 13.2)
Joint pain: mild	12.5 (4.2 to 26.8)	10.0 (2.8 to 23.7)	5.0 (0.6 to 16.9)	9.5 (2.7 to 22.6)	10.0 (2.8 to 23.7)	7.5 (1.6 to 20.4)	7.3 (1.5 to 19.9)	7.3 (1.5 to 19.9)	12.5 (4.2 to 26.8)	7.3 (1.5 to 19.9)	21.4 (10.3 to 36.8)	2.3 (0.1 to 12.3)	7.5 (1.6 to 20.4)
Joint pain: moderate	7.5 (1.6 to 20.4)	5.0 (0.6 to 16.9)	5.0 (0.6 to 16.9)	9.5 (2.7 to 22.6)	5.0 (0.6 to 16.9)	7.5 (1.6 to 20.4)	4.9 (0.6 to 16.5)	7.3 (1.5 to 19.9)	0 (0.0 to 8.8)	9.8 (2.7 to 23.1)	7.1 (1.5 to 19.5)	4.7 (0.6 to 15.8)	7.5 (1.6 to 20.4)
Joint pain: severe	0 (0.0 to 8.8)	2.5 (0.1 to 13.2)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	4.9 (0.6 to 16.5)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.4)	0 (0.0 to 8.2)	0 (0.0 to 8.8)
Vomiting: mild	0 (0.0 to 8.8)	2.5 (0.1 to 13.2)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	2.4 (0.1 to 12.9)	2.5 (0.1 to 13.2)	0 (0.0 to 8.6)	0 (0.0 to 8.4)	2.3 (0.1 to 12.3)	0 (0.0 to 8.8)
Vomiting: moderate	0 (0.0 to 8.8)	2.5 (0.1 to 13.2)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	4.9 (0.6 to 16.5)	2.5 (0.1 to 13.2)	2.4 (0.1 to 12.9)	0 (0.0 to 8.4)	0 (0.0 to 8.2)	0 (0.0 to 8.8)
Vomiting: severe	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.4)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.4)	0 (0.0 to 8.2)	0 (0.0 to 8.8)
Diarrhea: mild	5.0 (0.6 to 16.9)	15.0 (5.7 to 29.8)	20.0 (9.1 to 35.6)	7.1 (1.5 to 19.5)	5.0 (0.6 to 16.9)	2.5 (0.1 to 13.2)	7.3 (1.5 to 19.9)	7.3 (1.5 to 19.9)	17.5 (7.3 to 32.8)	7.3 (1.5 to 19.9)	14.3 (5.4 to 28.5)	2.3 (0.1 to 12.3)	5.0 (0.6 to 16.9)
Diarrhea: moderate	2.5 (0.1 to 13.2)	2.5 (0.1 to 13.2)	2.5 (0.1 to 13.2)	2.4 (0.1 to 12.6)	5.0 (0.6 to 16.9)	2.5 (0.1 to 13.2)	2.4 (0.1 to 12.9)	7.3 (1.5 to 19.9)	7.5 (1.6 to 20.4)	2.4 (0.1 to 12.9)	0 (0.0 to 8.4)	4.7 (0.6 to 15.8)	0 (0.0 to 8.8)
Diarrhea: severe	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	2.4 (0.1 to 12.6)	0 (0.0 to 8.8)	0 (0.0 to 8.8)	0 (0.0 to 8.6)	0 (0.0 to 8.6)	0 (0.0 to 8.8)	2.4 (0.1 to 12.9)	0 (0.0 to 8.4)	2.3 (0.1 to 12.3)	2.5 (0.1 to 13.2)

PrimarySentinel 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)
Reported as:: Number · Percentage of participants

Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination
Percentage of participants	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: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination	16.7 (2.1 to 48.4)	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	16.7 (2.1 to 48.4)	8.3 (0.2 to 38.5)

PrimarySentinel 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)
Reported as:: Number · Percentage of participants

Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination
Percentage of participants	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
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination	25.0 (5.5 to 57.2)	25.0 (5.5 to 57.2)	8.3 (0.2 to 38.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	0.0 (0.0 to 26.5)

PrimaryExpanded 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)
Reported as:: Number · Percentage of participants

Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1
Percentage of participants	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 and SIIV 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: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1	17.1 (7.2 to 32.1)	16.7 (7.0 to 31.4)	14.6 (5.6 to 29.2)	22.5 (10.8 to 38.5)	24.4 (12.4 to 40.3)	22.0 (10.6 to 37.6)	7.3 (1.5 to 19.9)	22.0 (10.6 to 37.6)	9.8 (2.7 to 23.1)	12.2 (4.1 to 26.2)	12.2 (4.1 to 26.2)	17.1 (7.2 to 32.1)	9.8 (2.7 to 23.1)

PrimaryExpanded 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)
Reported as:: Number · Percentage of participants

Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination
Percentage of participants	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
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination	10.0 (2.8 to 23.7)	14.6 (5.6 to 29.2)	5.0 (0.6 to 16.9)	26.2 (13.9 to 42.0)	22.5 (10.8 to 38.5)	20.0 (9.1 to 35.6)	14.6 (5.6 to 29.2)	14.6 (5.6 to 29.2)	15.0 (5.7 to 29.8)	9.8 (2.7 to 23.1)	11.9 (4.0 to 25.6)	16.3 (6.8 to 30.7)	12.2 (4.1 to 26.2)

PrimarySentinel 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)
Reported as:: Number · Percentage of participants

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
Percentage of participants	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
MAEs	33.3 (9.9 to 65.1)	0 (0.0 to 26.5)	25.0 (5.5 to 57.2)	16.7 (2.1 to 48.4)	8.3 (0.2 to 38.5)	25.0 (5.5 to 57.2)	16.7 (2.1 to 48.4)
SAEs	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)

PrimarySentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination

Time frame:: Upto 12 months after vaccination (upto 378 days)
Reported as:: Number · Percentage of participants

Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination
Percentage of participants	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
MAEs	25.0 (5.5 to 57.2)	50.0 (21.1 to 78.9)	25.0 (5.5 to 57.2)	25.0 (5.5 to 57.2)	25.0 (5.5 to 57.2)	16.7 (2.1 to 48.4)	16.7 (2.1 to 48.4)
SAEs	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	8.3 (0.2 to 38.5)	16.7 (2.1 to 48.4)	0 (0.0 to 26.5)

PrimaryExpanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1

Time frame:: Upto 12 months after vaccination 1 (upto 378 days)
Reported as:: Number · Percentage of participants

Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1
Percentage of participants	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 and SIIV 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
MAEs	22.0 (10.6 to 37.6)	14.3 (5.4 to 28.5)	9.8 (2.7 to 23.1)	17.5 (7.3 to 32.8)	22.0 (10.6 to 37.6)	19.5 (8.8 to 34.9)	12.2 (4.1 to 26.2)	24.4 (12.4 to 40.3)	24.4 (12.4 to 40.3)	22.0 (10.6 to 40.3)	24.4 (12.4 to 40.3)	22.0 (10.6 to 37.6)	22.0 (10.6 to 37.6)
SAEs	2.4 (0.1 to 12.9)	0 (0.0 to 8.4)	0 (0.0 to 8.6)	2.5 (0.1 to 13.2)	2.4 (0.1 to 12.9)	4.9 (0.6 to 16.5)	0 (0.0 to 8.6)	4.9 (0.6 to 16.5)	4.9 (0.6 to 16.5)	2.4 (0.1 to 12.9)	2.4 (0.1 to 12.9)	7.3 (1.5 to 19.9)	2.4 (0.1 to 12.9)

PrimaryExpanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1

Time frame:: Upto 12 months after vaccination 1 (upto 378 days)
Reported as:: Number · Percentage of participants

Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1
Percentage of participants	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
MAEs	15.0 (5.7 to 29.8)	24.4 (12.4 to 40.3)	30.0 (16.6 to 46.5)	31.0 (17.6 to 47.1)	22.5 (10.8 to 38.5)	22.5 (10.8 to 38.5)	17.1 (7.2 to 32.1)	34.1 (20.1 to 50.6)	47.5 (31.5 to 63.9)	43.9 (28.5 to 60.3)	28.6 (15.7 to 44.6)	25.6 (13.5 to 41.2)	14.6 (5.6 to 29.2)
SAEs	5.0 (0.6 to 16.9)	17.1 (7.2 to 32.1)	10.0 (2.8 to 23.7)	19.0 (8.6 to 34.1)	10.0 (2.8 to 23.7)	5.0 (0.6 to 16.9)	17.1 (7.2 to 32.1)	4.9 (0.6 to 16.5)	10.0 (2.8 to 23.7)	7.3 (1.5 to 19.9)	7.1 (1.5 to 19.5)	7.0 (1.5 to 19.1)	7.3 (1.5 to 19.9)

PrimaryExpanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2

Time frame:: Within 1 month after vaccination 2 (upto Day 70)
Reported as:: Number · Percentage of participants

Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2
Percentage of participants	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 and SIIV 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: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2	19.5 (8.8 to 34.9)	14.3 (5.4 to 28.5)	19.5 (8.8 to 34.9)	10.0 (2.8 to 23.7)	7.3 (1.5 to 19.9)	17.1 (7.2 to 32.1)	22.0 (10.6 to 37.6)	14.6 (5.6 to 29.2)	26.8 (14.2 to 42.9)	26.8 (14.2 to 42.9)	19.5 (8.8 to 34.9)	17.1 (7.2 to 32.1)	9.8 (2.7 to 23.1)

PrimaryExpanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2

Time frame:: Within 1 month after vaccination 2 (upto Day 70)
Reported as:: Number · Percentage of participants

Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2
Percentage of participants	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
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2	10.0 (2.8 to 23.7)	7.3 (1.5 to 19.9)	20.0 (9.1 to 35.6)	21.4 (10.3 to 36.8)	25.0 (12.7 to 41.2)	30.0 (16.6 to 46.5)	12.2 (4.1 to 26.2)	9.8 (2.7 to 23.1)	32.5 (18.6 to 49.1)	24.4 (12.4 to 40.3)	11.9 (4.0 to 25.6)	18.6 (8.4 to 33.4)	17.1 (7.2 to 32.1)

SecondarySentinel 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
Reported as:: Geometric mean · Titers

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)
Titers	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
RSV A: before vaccination 1	1319 (639.4 to 2720.0)	1754 (1053.6 to 2919.0)	1090 (636.6 to 1867.2)	1531 (939.0 to 2495.5)	2029 (1186.2 to 3471.1)	1553 (997.5 to 2416.8)	1229 (666.0 to 2267.8)
RSV A: 2 Weeks after vaccination 1	20936 (16760.8 to 26151.7)	24970 (15120.8 to 41235.7)	31584 (19599.9 to 50897.0)	31193 (18221.6 to 53399.1)	44866 (27431.6 to 73379.3)	52339 (41244.0 to 66419.5)	2817 (1279.8 to 6200.0)
RSV A: 1 Month after vaccination 1	16730 (10482.1 to 26701.2)	20512 (10692.1 to 39349.2)	10021 (5439.7 to 18461.5)	16521 (8363.4 to 32634.1)	27892 (11836.8 to 65726.0)	28453 (17960.2 to 45076.0)	2430 (1059.5 to 5572.8)
RSV A: 2 Months after vaccination 1	12702 (7774.1 to 20752.2)	28577 (17569.4 to 46482.7)	11171 (7299.6 to 17095.6)	15529 (8421.5 to 28636.3)	23033 (15199.1 to 34905.6)	18883 (11903.1 to 29955.5)	1851 (872.8 to 3925.5)
RSV A:3 Months after vaccination 1	8258 (5436.7 to 12544.3)	15276 (8311.3 to 28077.4)	10800 (5629.4 to 20720.5)	12421 (6536.5 to 23602.4)	19654 (11887.0 to 32494.6)	12922 (8416.3 to 19839.5)	1560 (871.7 to 2791.5)
RSV A:6 Months after vaccination 1	11466 (7413.8 to 17733.3)	22737 (13621.9 to 37952.6)	12034 (6531.3 to 22173.9)	9707 (5968.0 to 15788.1)	13672 (8854.3 to 21111.5)	8237 (5457.7 to 12430.7)	2658 (1713.6 to 4121.5)
RSV A: 12 Months after vaccination 1	4430 (1406.2 to 13954.0)	11052 (6489.0 to 18822.7)	6147 (3027.2 to 12480.5)	5849 (2465.2 to 13876.7)	9851 (6172.1 to 15722.6)	8707 (5584.9 to 13573.9)	2043 (1043.0 to 4002.1)
RSV B: before vaccination 1	1427 (696.9 to 2921.5)	2077 (1318.2 to 3274.2)	995 (468.6 to 2111.4)	1670 (987.2 to 2826.2)	1600 (884.5 to 2895.1)	1492 (946.5 to 2353.0)	1393 (600.9 to 3227.2)
RSV B: 2 Weeks after vaccination 1	23974 (17227.4 to 33364.1)	22491 (12970.4 to 38999.0)	32104 (22689.9 to 45424.2)	42222 (18956.4 to 94043.4)	59752 (32986.4 to 108235.8)	59955 (39010.7 to 92143.8)	2817 (1109.7 to 7150.1)
RSV B: 1 Month after vaccination 1	18932 (11958.2 to 29973.5)	19197 (9637.0 to 38241.0)	8510 (5282.6 to 13708.4)	18080 (8223.8 to 39749.5)	26759 (10616.0 to 67451.3)	29668 (17559.4 to 50125.0)	1861 (657.4 to 5265.8)
RSV B: 2 Months after vaccination 1	13959 (8783.3 to 22184.4)	28374 (15306.1 to 52600.1)	8760 (5253.7 to 14607.8)	16167 (7902.3 to 33077.1)	19534 (10586.7 to 36042.0)	18280 (10621.2 to 31462.6)	1604 (606.9 to 4238.4)
RSV B: 3 Months after vaccination 1	9688 (6307.1 to 14882.3)	12697 (7257.0 to 22214.4)	8833 (5170.6 to 15088.1)	11986 (5852.2 to 24549.6)	16706 (8822.8 to 31633.4)	11588 (6572.0 to 20434.1)	1613 (780.6 to 3331.5)
RSV B: 6 Months after vaccination 1	15235 (7604.2 to 30523.5)	16492 (10319.2 to 26357.8)	10918 (5615.7 to 21225.9)	11658 (6759.2 to 20107.4)	11857 (6383.5 to 22021.8)	7435 (4660.4 to 11862.2)	2865 (1655.5 to 4960.0)
RSV B: 12 Months after vaccination 1	4674 (1561.6 to 13991.5)	9274 (5661.4 to 15192.8)	4127 (2331.4 to 7303.9)	5392 (2058.4 to 14125.8)	8565 (4633.3 to 15832.7)	7373 (4569.2 to 11897.9)	1970 (839.1 to 4625.6)

SecondarySentinel 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
Reported as:: Geometric mean · Titers

Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years)
Titers	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
RSV A: before vaccination 1	1904 (1278.7 to 2834.4)	1672 (1040.7 to 2686.7)	2056 (1331.2 to 3173.9)	1923 (1005.6 to 3678.3)	1923 (1336.2 to 2766.2)	1564 (937.6 to 2607.5)	2359 (1410.7 to 3943.4)
RSV A: 2 Weeks after vaccination 1	17464 (8895.2 to 34285.4)	22594 (11704.0 to 43617.7)	31946 (20617.5 to 49500.7)	30618 (19555.9 to 47936.7)	29812 (19802.0 to 44882.0)	40272 (21945.3 to 73902.5)	2233 (1688.2 to 2953.0)
RSV A: 1 Month after vaccination 1	21116 (10249.1 to 43505.0)	21788 (13645.3 to 34789.6)	23161 (13893.6 to 38609.1)	20499 (14652.3 to 28677.5)	24481 (14704.5 to 40757.9)	36197 (23048.4 to 56845.6)	2675 (1318.3 to 5428.2)
RSV A: 2 Months after vaccination 1	15025 (7591.1 to 29738.7)	10949 (6413.2 to 18694.3)	16441 (10140.5 to 26656.3)	10493 (6930.9 to 15884.4)	12659 (8728.3 to 18358.5)	13723 (6897.6 to 27300.9)	1502 (1051.7 to 2143.7)
RSV A:3 Months after vaccination 1	9792 (5705.9 to 16804.9)	12202 (8157.6 to 18250.8)	11476 (6917.1 to 19038.6)	11561 (6851.2 to 19508.3)	11195 (7550.0 to 16599.6)	12747 (5865.4 to 27701.7)	1543 (1045.0 to 2276.9)
RSV A:6 Months after vaccination 1	12290 (6656.1 to 22693.9)	10213 (6473.8 to 16111.2)	12795 (8778.0 to 18649.5)	12172 (6876.4 to 21545.6)	7083 (4674.4 to 10732.7)	9417 (5251.7 to 16885.6)	1945 (1081.1 to 3498.6)
RSV A: 12 Months after vaccination 1	9446 (5677.6 to 15715.0)	7507 (4093.7 to 13766.5)	8484 (5809.9 to 12390.3)	10709 (6444.0 to 17798.1)	2705 (644.6 to 11353.2)	4145 (1867.0 to 9204.4)	2341 (1216.8 to 4502.5)
RSV B: before vaccination 1	2573 (1589.0 to 4166.1)	1139 (693.5 to 1871.0)	1190 (670.8 to 2111.9)	1568 (755.8 to 3254.9)	2144 (1317.6 to 3490.2)	1417 (872.5 to 2301.3)	2285 (1440.4 to 3624.1)
RSV B: 2 Weeks after vaccination 1	27923 (14883.3 to 52385.8)	19751 (10180.1 to 38319.0)	25820 (11849.7 to 56262.2)	33779 (19683.4 to 57969.0)	47514 (26993.7 to 83633.1)	41776 (20962.6 to 83256.1)	2441 (1741.5 to 3421.0)
RSV B: 1 Month after vaccination 1	27789 (14463.8 to 53392.0)	21429 (10960.1 to 41899.2)	16610 (7522.2 to 36678.1)	19632 (13014.2 to 29615.5)	32668 (18110.7 to 58926.6)	37852 (22637.3 to 63291.6)	3104 (1630.2 to 5908.9)
RSV B: 2 Months after vaccination 1	19061 (9784.0 to 37133.0)	10713 (5704.5 to 20118.3)	11284 (5285.1 to 24091.8)	9247 (5754.6 to 14860.4)	15567 (9281.5 to 26110.1)	12441 (7391.4 to 20941.9)	1461 (995.6 to 2143.4)
RSV B: 3 Months after vaccination 1	12225 (5963.9 to 25058.3)	10364 (5186.7 to 20708.8)	7190 (3217.8 to 16066.1)	11138 (6751.8 to 18373.7)	12998 (7277.3 to 23215.1)	11726 (6130.9 to 22427.1)	1436 (938.4 to 2196.9)
RSV B: 6 Months after vaccination 1	16998 (7585.9 to 38087.5)	11281 (6198.0 to 20531.5)	8636 (4397.3 to 16960.1)	12541 (6303.2 to 24951.9)	6949 (4175.8 to 11565.2)	8066 (4681.5 to 13896.6)	1920 (1307.0 to 2821.0)
RSV B: 12 Months after vaccination 1	9721 (4894.4 to 19308.4)	5801 (3688.7 to 9122.8)	6174 (3406.1 to 11192.6)	8589 (4898.5 to 15059.1)	3230 (765.7 to 13626.8)	2918 (855.6 to 9948.1)	2188 (1398.7 to 3423.8)

SecondaryExpanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)

Time frame:: Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
Reported as:: Geometric mean · Titers

Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)
Titers	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 and SIIV 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
RSV A: before vaccination 1	1998 (1544.9 to 2583.6)	1471 (1136.8 to 1904.1)	1518 (1124.2 to 2049.1)	1768 (1355.5 to 2305.0)	1297 (995.4 to 1689.3)	1713 (1288.9 to 2276.8)	1862 (1443.5 to 2402.8)	1933 (1531.1 to 2440.5)	1733 (1352.7 to 2220.3)	1640 (1175.5 to 2289.3)	1522 (1162.6 to 1991.9)	1625 (1209.9 to 2183.4)	1750 (1398.4 to 2190.0)
RSV A: 1 Month after vaccination 1	17482 (13630.9 to 22420.4)	21728 (17712.2 to 26655.0)	17460 (12975.9 to 23494.5)	18064 (13868.8 to 23527.5)	17760 (13990.9 to 22544.3)	22628 (17718.2 to 28899.1)	26465 (20604.2 to 33993.1)	25860 (18817.4 to 35539.3)	23783 (18268.5 to 30962.6)	29332 (24173.0 to 35591.1)	21196 (15702.1 to 28611.6)	26938 (20516.3 to 35369.1)	1883 (1465.0 to 2419.5)
RSV A: 2 Months after vaccination 1	10247 (8239.7 to 12743.8)	11976 (9521.6 to 15064.2)	10326 (7936.9 to 13433.2)	12522 (9469.3 to 16557.6)	9595 (7224.8 to 12743.7)	14140 (11050.3 to 18093.4)	15754 (11605.8 to 21383.9)	13518 (10423.6 to 17530.1)	13790 (10401.4 to 18281.4)	14999 (11660.3 to 19294.4)	11533 (8867.3 to 14999.7)	12812 (9507.1 to 17265.5)	1252 (988.9 to 1584.0)
RSV A:3 Months after vaccination 1	11164 (8453.8 to 14743.3)	12664 (10280.1 to 15600.9)	12042 (9262.7 to 15655.6)	12773 (9651.2 to 16903.6)	9205 (7081.5 to 11965.6)	13801 (10058.5 to 18934.9)	15360 (11695.6 to 20172.0)	13663 (10498.8 to 17779.9)	11805 (9135.4 to 15255.7)	14570 (11447.8 to 18544.3)	12273 (9077.2 to 16595.1)	10764 (7824.2 to 14807.5)	1718 (1389.8 to 2123.4)
RSV A:6 Months after vaccination 1	8403 (6386.5 to 11056.6)	8118 (6048.2 to 10896.6)	9568 (7416.5 to 12343.6)	9533 (7128.0 to 12748.9)	6492 (4911.2 to 8580.7)	10324 (7545.2 to 14125.7)	10005 (7832.8 to 12780.0)	10237 (7792.7 to 13447.1)	7768 (5960.2 to 10123.8)	10343 (7596.7 to 14082.5)	8823 (6401.5 to 12160.3)	8210 (5890.4 to 11443.8)	2031 (1613.7 to 2556.1)
RSV A: 12 Months after vaccination 1	7679 (5830.0 to 10114.5)	7050 (4686.3 to 10605.3)	7640 (6033.3 to 9673.4)	9062 (6616.6 to 12411.7)	4889 (3243.0 to 7370.6)	8435 (5784.9 to 12300.3)	9174 (6766.8 to 12438.6)	8231 (6167.4 to 10986.4)	6919 (4936.1 to 9698.5)	6983 (5099.0 to 9562.3)	6769 (4811.0 to 9522.9)	5658 (3602.1 to 8888.6)	1994 (1445.8 to 2751.0)
RSV B: before vaccination 1	1847 (1415.4 to 2410.9)	1475 (1117.0 to 1949.1)	1516 (1120.5 to 2050.8)	1586 (1182.6 to 2127.6)	1460 (1131.3 to 1884.3)	1502 (1123.0 to 2010.2)	1739 (1396.0 to 2166.4)	1733 (1334.2 to 2251.6)	1480 (1123.8 to 1949.5)	1520 (1116.7 to 2067.9)	1363 (1029.7 to 1803.0)	1584 (1147.9 to 2185.8)	1783 (1371.8 to 2316.9)
RSV B: 1 Month after vaccination 1	17583 (13214.1 to 23395.6)	19561 (15064.1 to 25399.1)	18762 (13685.5 to 25721.9)	16835 (12239.1 to 23157.8)	18929 (14318.0 to 25025.3)	24395 (18501.1 to 32165.3)	23560 (18937.0 to 29311.1)	22928 (16479.1 to 31901.0)	23481 (17190.7 to 32072.3)	31571 (25226.8 to 39511.5)	21150 (15284.8 to 29265.8)	28166 (21107.4 to 37585.2)	1748 (1329.6 to 2299.0)
RSV B: 2 Months after vaccination 1	10259 (8034.9 to 13099.5)	11771 (8638.2 to 16040.4)	11441 (8386.4 to 15607.7)	11253 (8111.2 to 15611.0)	10486 (7919.2 to 13884.8)	14223 (10536.4 to 19200.6)	15173 (11310.1 to 20356.1)	11716 (8515.6 to 16119.1)	12850 (9187.3 to 17972.3)	16485 (12365.4 to 21978.4)	11148 (8237.5 to 15087.2)	14024 (10061.6 to 19547.9)	1447 (1079.9 to 1939.5)
RSV B: 3 Months after vaccination 1	11694 (8668.6 to 15774.1)	12016 (9365.0 to 15416.8)	12852 (9598.1 to 17209.5)	11719 (8535.2 to 16091.6)	9953 (7528.7 to 13159.2)	13011 (9004.5 to 18800.0)	13364 (10482.3 to 17038.8)	11333 (8551.7 to 15018.5)	10567 (8130.7 to 13732.8)	14638 (11159.9 to 19200.0)	10322 (7548.2 to 14113.9)	11146 (7975.6 to 15576.6)	1839 (1439.5 to 2349.4)
RSV B: 6 Months after vaccination 1	8102 (6262.1 to 10481.3)	8411 (6558.5 to 10786.8)	9954 (7389.7 to 13407.1)	8667 (6315.1 to 11895.8)	6640 (5134.2 to 8586.8)	9482 (6798.6 to 13225.5)	9702 (7732.8 to 12172.6)	8836 (6541.4 to 11934.4)	7244 (5597.4 to 9374.1)	11073 (7984.1 to 15356.1)	8235 (5889.9 to 11513.3)	8856 (6341.0 to 12367.3)	2171 (1687.8 to 2792.3)
RSV B: 12 Months after vaccination 1	7539 (5917.8 to 9603.1)	7413 (5610.6 to 9795.7)	7651 (5627.3 to 10403.5)	7629 (5427.0 to 10723.6)	5778 (4201.0 to 7947.8)	7747 (5099.8 to 11767.6)	8492 (6382.7 to 11297.8)	7177 (5333.3 to 9658.8)	6078 (4465.2 to 8274.7)	7086 (5112.3 to 9820.9)	6133 (4215.6 to 8923.1)	5494 (3465.4 to 8710.7)	2017 (1503.9 to 2705.9)

SecondaryExpanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years)

Time frame:: Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
Reported as:: Geometric mean · Titers

Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years)
Titers	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
RSV A: before vaccination 1	2129 (1577.8 to 2872.8)	2096 (1518.6 to 2892.0)	2064 (1638.5 to 2598.9)	2461 (1856.2 to 3262.5)	2269 (1708.5 to 3013.4)	2269 (1802.6 to 2855.8)	2578 (1945.6 to 3416.6)	2089 (1535.1 to 2843.5)	2203 (1731.5 to 2802.0)	1965 (1539.1 to 2508.5)	1793 (1351.8 to 2378.8)	2734 (1963.5 to 3807.4)	1585 (1252.3 to 2005.5)
RSV A: 1 Month after vaccination 1	16007 (12504.7 to 20489.7)	20417 (14920.6 to 27937.5)	14905 (11631.7 to 19098.2)	19625 (14184.9 to 27151.3)	25065 (19629.1 to 32006.7)	22318 (15850.6 to 31425.6)	23566 (17457.3 to 31812.3)	27600 (21382.5 to 35624.6)	22184 (16026.2 to 30708.8)	21601 (16659.4 to 28007.6)	23510 (17822.0 to 31013.3)	25815 (19944.3 to 33412.8)	1697 (1250.6 to 2301.8)
RSV A: 2 Months after vaccination 1	9452 (7428.7 to 12027.1)	13199 (10283.1 to 16941.3)	9922 (7222.7 to 13630.8)	15484 (11526.9 to 20800.1)	16288 (11911.8 to 22271.2)	12740 (9523.2 to 17044.6)	11939 (9013.1 to 15815.1)	15840 (11770.4 to 21316.0)	14438 (10978.8 to 18988.3)	14542 (11233.0 to 18825.2)	16797 (12172.8 to 23178.9)	17410 (13396.9 to 22624.1)	1414 (1074.8 to 1859.1)
RSV A:3 Months after vaccination 1	12010 (9596.8 to 15028.9)	14230 (10948.0 to 18497.1)	10362 (7851.6 to 13675.7)	15345 (11425.0 to 20610.2)	16637 (13056.4 to 21199.4)	14957 (11432.2 to 19567.5)	13675 (9813.9 to 19056.4)	16424 (12590.9 to 21424.4)	16089 (12483.9 to 20735.6)	12200 (9656.1 to 15413.8)	15291 (11066.0 to 21130.2)	16265 (12538.4 to 21100.0)	1772 (1437.1 to 2185.9)
RSV A:6 Months after vaccination 1	8452 (6630.3 to 10775.1)	11903 (9294.4 to 15242.5)	8444 (6262.1 to 11385.4)	10827 (8198.8 to 14299.0)	11871 (8636.7 to 16317.0)	10202 (7456.7 to 13958.5)	10226 (7555.1 to 13840.9)	13148 (10485.1 to 16487.1)	10769 (8228.7 to 14092.3)	9495 (7587.8 to 11881.8)	10578 (7678.5 to 14571.9)	11268 (8581.1 to 14795.8)	2057 (1480.4 to 2859.3)
RSV A: 12 Months after vaccination 1	7732 (5994.9 to 9971.5)	7891 (5743.4 to 10841.2)	6518 (4825.7 to 8804.0)	9143 (6587.4 to 12689.9)	7942 (4956.1 to 12728.1)	8639 (6159.4 to 12116.2)	7731 (5491.0 to 10885.4)	9340 (6921.2 to 12603.7)	9738 (7079.7 to 13394.9)	5872 (3775.9 to 9132.2)	6946 (4590.1 to 10510.8)	8919 (6166.3 to 12899.3)	1931 (1440.0 to 2590.3)
RSV B: before vaccination 1	2198 (1573.7 to 3070.9)	1862 (1340.9 to 2586.5)	1999 (1506.1 to 2653.9)	2423 (1840.0 to 3191.1)	2314 (1659.8 to 3225.1)	2194 (1724.9 to 2790.8)	2685 (1949.1 to 3698.5)	2032 (1414.4 to 2920.4)	2586 (1999.1 to 3344.0)	2241 (1689.0 to 2972.7)	1635 (1155.3 to 2313.4)	2390 (1744.5 to 3274.4)	1766 (1371.2 to 2275.6)
RSV B: 1 Month after vaccination 1	15172 (10995.0 to 20936.5)	20553 (14241.6 to 29660.2)	15169 (11469.2 to 20063.1)	20421 (13852.5 to 30105.7)	24257 (17639.8 to 33356.3)	18648 (12034.5 to 28896.9)	24158 (16688.4 to 34969.9)	30071 (21347.9 to 42359.2)	27996 (19063.0 to 41115.9)	25080 (17447.2 to 36052.5)	24320 (17529.7 to 33741.2)	25719 (18637.2 to 35491.1)	1664 (1229.2 to 2252.4)
RSV B: 2 Months after vaccination 1	9162 (6658.1 to 12608.1)	14085 (10386.5 to 19100.9)	9928 (6957.8 to 14166.3)	16107 (11164.1 to 23237.5)	14496 (9907.2 to 21210.5)	10893 (7861.3 to 15092.6)	11605 (8207.0 to 16410.6)	17024 (11790.9 to 24580.3)	17255 (12641.8 to 23552.0)	16376 (11778.6 to 22767.4)	17706 (12608.5 to 24864.7)	17268 (13010.8 to 22917.7)	1413 (1093.7 to 1824.7)
RSV B: 3 Months after vaccination 1	12578 (8794.3 to 17989.3)	13735 (10112.3 to 18654.7)	9741 (6327.5 to 14996.3)	15856 (11221.3 to 22404.0)	14163 (10608.8 to 18908.1)	11927 (8704.5 to 16343.6)	13631 (9258.0 to 20070.2)	16675 (11847.7 to 23468.8)	18557 (13406.8 to 25686.3)	13452 (9659.9 to 18731.6)	15031 (10537.4 to 21442.2)	14645 (10736.8 to 19976.6)	1995 (1627.0 to 2446.5)
RSV B: 6 Months after vaccination 1	8429 (6127.1 to 11596.0)	11417 (8472.7 to 15384.7)	7869 (5884.7 to 10521.8)	11739 (8330.6 to 16542.4)	10606 (7585.3 to 14830.1)	9270 (6321.4 to 13592.7)	10384 (6793.2 to 15872.9)	13562 (10077.8 to 18251.6)	11710 (8535.9 to 16064.2)	10597 (7911.2 to 14195.9)	10645 (7424.7 to 15262.1)	10875 (8159.0 to 14496.1)	2374 (1633.3 to 3452.0)
RSV B: 12 Months after vaccination 1	7467 (5426.5 to 10274.0)	7969 (5671.5 to 11196.5)	6445 (4561.6 to 9106.0)	9200 (6460.4 to 13101.5)	7573 (4659.2 to 12310.2)	6634 (4565.5 to 9639.4)	7449 (5139.4 to 10796.7)	9256 (6496.9 to 13186.5)	9855 (6874.6 to 14127.4)	6809 (4274.8 to 10846.9)	7001 (4436.2 to 11049.8)	8500 (5551.2 to 13016.2)	2058 (1525.8 to 2775.8)

SecondaryExpanded 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
Reported as:: Geometric mean · Titers

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)
Titers	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 and SIIV 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
A-H1N1: before SIIV	44.5 (30.34 to 65.26)	25.0 (17.15 to 36.51)	38.0 (25.74 to 56.03)	33.7 (22.47 to 50.53)	18.9 (13.51 to 26.47)	27.0 (16.99 to 42.96)	29.6 (19.01 to 45.99)	26.1 (16.68 to 40.85)	20.5 (14.21 to 29.48)	28.7 (18.16 to 45.28)	32.1 (22.97 to 44.88)	22.7 (14.61 to 35.35)	33.5 (21.85 to 51.43)
A-H1N1: 1 month after SIIV	77.2 (55.13 to 108.07)	95.3 (65.73 to 138.06)	85.8 (63.75 to 115.37)	114.0 (75.09 to 173.00)	62.4 (45.56 to 85.46)	113.5 (73.56 to 175.25)	70.2 (46.13 to 106.88)	128.8 (87.91 to 188.58)	57.2 (43.42 to 75.40)	83.6 (58.45 to 119.71)	72.3 (54.40 to 96.16)	114.4 (81.16 to 161.24)	126.9 (91.78 to 175.60)
A-H3N2: before SIIV	35.1 (23.42 to 52.58)	25.4 (16.15 to 39.89)	32.7 (22.27 to 47.91)	35.7 (22.14 to 57.44)	23.9 (15.90 to 36.02)	28.8 (18.02 to 45.95)	30.3 (18.90 to 48.56)	25.7 (15.10 to 43.83)	20.9 (13.37 to 32.81)	22.4 (14.54 to 34.63)	32.3 (21.51 to 48.44)	20.3 (13.25 to 31.06)	34.4 (23.03 to 51.44)
A-H3N2: 1 month after SIIV	77.7 (54.76 to 110.11)	129.6 (84.87 to 198.00)	81.4 (58.32 to 113.57)	158.8 (113.23 to 222.77)	85.2 (57.22 to 126.96)	120.0 (77.87 to 185.00)	74.5 (50.39 to 110.25)	130.6 (83.11 to 205.23)	81.4 (59.53 to 111.30)	82.1 (56.50 to 119.19)	95.8 (67.10 to 136.84)	134.8 (92.88 to 195.69)	152.5 (114.26 to 203.64)
B1: before SIIV	13.2 (9.24 to 18.73)	10.3 (7.64 to 13.87)	10.8 (7.81 to 14.93)	13.3 (8.97 to 19.86)	7.3 (5.92 to 9.06)	13.0 (9.12 to 18.43)	8.7 (6.61 to 11.53)	9.5 (6.64 to 13.46)	8.3 (6.27 to 11.03)	9.4 (6.75 to 13.22)	12.6 (9.30 to 17.06)	9.2 (6.77 to 12.55)	10.5 (8.05 to 13.68)
B1: 1 month after SIIV	23.5 (17.09 to 32.25)	41.7 (27.86 to 62.52)	29.3 (20.47 to 41.97)	47.2 (29.73 to 74.99)	18.4 (13.75 to 24.74)	38.4 (25.91 to 56.86)	19.1 (13.83 to 26.41)	32.7 (20.81 to 51.27)	15.5 (11.28 to 21.39)	22.3 (15.61 to 31.85)	23.8 (18.32 to 30.95)	25.6 (16.86 to 38.82)	31.8 (21.21 to 47.55)
B2: before SIIV	16.3 (11.09 to 23.85)	11.7 (8.93 to 15.24)	12.5 (9.29 to 16.71)	18.4 (12.60 to 26.73)	9.3 (7.16 to 12.20)	12.8 (9.20 to 17.77)	11.5 (8.68 to 15.30)	10.6 (7.32 to 15.27)	10.4 (7.84 to 13.83)	12.3 (8.75 to 17.25)	11.6 (8.73 to 15.53)	11.2 (8.19 to 15.31)	13.1 (9.74 to 17.69)
B2: 1 month after SIIV	29.0 (21.07 to 40.04)	39.4 (27.06 to 57.46)	27.8 (20.40 to 37.97)	46.9 (31.34 to 70.31)	22.6 (17.56 to 29.11)	28.4 (18.66 to 43.17)	22.3 (16.17 to 30.65)	39.7 (25.21 to 62.56)	20.1 (14.73 to 27.51)	28.7 (20.16 to 40.71)	25.9 (19.08 to 35.19)	37.5 (27.37 to 51.25)	36.2 (26.26 to 49.80)

SecondaryExpanded 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
Reported as:: Geometric mean · Titers

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)
Titers	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
A-H1N1: before SIIV	13.8 (10.12 to 18.94)	14.8 (9.94 to 21.93)	11.0 (8.67 to 13.87)	13.4 (9.34 to 19.10)	16.6 (11.42 to 24.03)	12.3 (8.63 to 17.53)	17.5 (11.91 to 25.74)	14.4 (10.84 to 19.26)	17.8 (12.69 to 25.00)	15.2 (11.37 to 20.39)	15.6 (11.14 to 21.87)	22.5 (14.87 to 34.10)	17.6 (11.89 to 26.00)
A-H1N1: 1 month after SIIV	43.6 (29.44 to 64.44)	54.5 (36.01 to 82.60)	44.4 (30.05 to 65.55)	61.9 (44.30 to 86.50)	52.9 (37.69 to 74.31)	51.1 (33.92 to 76.97)	56.6 (36.12 to 88.61)	71.0 (50.60 to 99.77)	45.7 (31.63 to 66.00)	58.4 (40.56 to 84.11)	52.4 (33.76 to 81.37)	72.0 (48.76 to 106.23)	75.8 (52.94 to 108.40)
A-H3N2: before SIIV	29.7 (20.41 to 43.23)	24.7 (16.39 to 37.24)	26.2 (16.56 to 41.58)	22.9 (14.25 to 36.72)	34.6 (21.08 to 56.69)	23.5 (16.45 to 33.66)	30.5 (19.70 to 47.20)	35.7 (20.99 to 60.84)	22.5 (14.37 to 35.11)	32.6 (21.12 to 50.40)	34.7 (21.82 to 55.29)	44.5 (28.03 to 70.66)	28.7 (17.54 to 46.87)
A-H3N2: 1 month after SIIV	94.3 (62.80 to 141.58)	105.6 (67.56 to 164.96)	78.2 (50.07 to 122.27)	118.3 (78.75 to 177.68)	140.0 (95.48 to 205.23)	109.3 (69.69 to 171.51)	131.5 (87.38 to 197.83)	185.0 (107.84 to 317.50)	79.0 (55.60 to 112.38)	153.4 (98.53 to 238.89)	103.1 (63.41 to 167.73)	130.4 (76.49 to 222.29)	106.4 (64.27 to 176.25)
B1: before SIIV	9.4 (6.86 to 12.77)	8.6 (6.40 to 11.56)	12.9 (8.78 to 18.95)	8.5 (6.73 to 10.79)	11.1 (7.96 to 15.47)	10.4 (7.56 to 14.26)	11.5 (8.26 to 15.97)	8.7 (6.61 to 11.37)	8.7 (6.69 to 11.34)	8.5 (6.56 to 10.91)	9.5 (6.97 to 12.97)	8.6 (6.56 to 11.39)	9.1 (7.08 to 11.67)
B1: 1 month after SIIV	19.5 (13.45 to 28.32)	26.4 (17.77 to 39.22)	22.9 (16.22 to 32.19)	31.7 (22.89 to 43.96)	24.7 (16.82 to 36.39)	23.4 (16.25 to 33.69)	26.2 (17.56 to 39.20)	21.6 (15.13 to 30.72)	18.9 (12.77 to 27.89)	29.4 (19.44 to 44.45)	21.2 (15.17 to 29.64)	23.1 (16.58 to 32.32)	26.8 (17.35 to 41.34)
B2: before SIIV	7.7 (6.19 to 9.46)	7.7 (6.16 to 9.58)	9.6 (7.26 to 12.72)	8.0 (6.24 to 10.23)	10.6 (7.55 to 14.99)	8.2 (6.24 to 10.75)	9.9 (7.37 to 13.25)	6.9 (5.60 to 8.45)	7.9 (6.21 to 10.15)	8.3 (6.69 to 10.26)	8.6 (6.66 to 11.10)	8.4 (6.88 to 10.33)	7.3 (5.71 to 9.38)
B2: 1 month after SIIV	10.4 (8.00 to 13.44)	11.0 (8.01 to 15.02)	13.0 (9.15 to 18.37)	12.4 (8.84 to 17.30)	16.6 (11.67 to 23.50)	13.2 (9.48 to 18.31)	13.3 (9.49 to 18.76)	10.0 (7.94 to 12.62)	9.7 (7.57 to 12.35)	15.3 (10.49 to 22.39)	10.9 (8.02 to 14.77)	13.2 (9.99 to 17.46)	13.2 (9.13 to 19.16)

Adverse events

Collected over Local reactions and systemic events collected as Non-SAEs: within 14 days after Vaccination (Vax) 1 and Vax 3 (for revaccination); Other Non-SAEs: Vax 1 up to 1 month after Vax 1, Vax 3 up to 1 month after Vax 3 for revaccination; SAEs: Vax 1 up to 12 months after Vax 1 (approximately up to 378 days), Vax 1 up to 12 months after Vax 3 for revaccination (approximately up to 798 days). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years	0/12 (0%)	0/12 (0%)	9/12 (75%)
Sentinel Cohort: RSV 120 mcg Age 18-49 Years	0/12 (0%)	0/12 (0%)	6/12 (50%)
Sentinel Cohort: RSV 240 mcg Age 18-49 Years	0/12 (0%)	0/12 (0%)	7/12 (58.3%)
Sentinel Cohort: Placebo Age 18-49 Years	0/12 (0%)	0/12 (0%)	6/12 (50%)
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years	0/12 (0%)	0/12 (0%)	7/12 (58.3%)
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years	0/12 (0%)	0/12 (0%)	7/12 (58.3%)
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years	1/12 (8.3%)	2/12 (16.7%)	8/12 (66.7%)
Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years	0/12 (0%)	0/12 (0%)	10/12 (83.3%)
Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years	0/12 (0%)	0/12 (0%)	11/12 (91.7%)
Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years	0/12 (0%)	0/12 (0%)	9/12 (75%)
Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years	0/12 (0%)	0/12 (0%)	8/12 (66.7%)
Sentinel Cohort: RSV 120 mcg Age 50-85 Years	0/12 (0%)	0/12 (0%)	5/12 (41.7%)
Sentinel Cohort: RSV 240 mcg Age 50-85 Years	0/12 (0%)	1/12 (8.3%)	5/12 (41.7%)
Sentinel Cohort: Placebo Age 50-85 Years	0/12 (0%)	0/12 (0%)	4/12 (33.3%)
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years	0/41 (0%)	1/41 (2.4%)	31/41 (75.6%)
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	0/41 (0%)	0/41 (0%)	36/41 (87.8%)
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years:	0/41 (0%)	1/41 (2.4%)	33/41 (80.5%)
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	0/41 (0%)	0/41 (0%)	35/41 (85.4%)
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years	1/41 (2.4%)	2/41 (4.9%)	35/41 (85.4%)
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	0/41 (0%)	1/41 (2.4%)	35/41 (85.4%)
Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years	0/41 (0%)	2/41 (4.9%)	31/41 (75.6%)
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years	0/41 (0%)	7/41 (17.1%)	24/41 (58.5%)
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	0/42 (0%)	8/42 (19%)	27/42 (64.3%)
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years	0/40 (0%)	2/40 (5%)	22/40 (55%)
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	1/41 (2.4%)	2/41 (4.9%)	25/41 (61%)
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years	1/41 (2.4%)	5/41 (12.2%)	28/41 (68.3%)
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	0/43 (0%)	3/43 (7%)	33/43 (76.7%)
Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years	0/42 (0%)	0/42 (0%)	32/42 (76.2%)
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	0/40 (0%)	1/40 (2.5%)	30/40 (75%)
Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years	1/41 (2.4%)	2/41 (4.9%)	33/41 (80.5%)
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	0/41 (0%)	2/41 (4.9%)	35/41 (85.4%)
Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years	0/41 (0%)	3/41 (7.3%)	32/41 (78%)
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	0/41 (0%)	3/41 (7.3%)	38/41 (92.7%)
Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years	0/40 (0%)	2/40 (5%)	22/40 (55%)
Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	0/40 (0%)	4/40 (10%)	20/40 (50%)
Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years:	0/40 (0%)	4/40 (10%)	21/40 (52.5%)
Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	1/41 (2.4%)	7/41 (17.1%)	21/41 (51.2%)
Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years	0/40 (0%)	5/40 (12.5%)	32/40 (80%)
Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	0/42 (0%)	4/42 (9.5%)	29/42 (69%)
Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years	0/41 (0%)	3/41 (7.3%)	21/41 (51.2%)

Most frequent serious events

Showing 10 of 70

Most frequent serious events
Event	Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years	Sentinel Cohort: RSV 120 mcg Age 18-49 Years	Sentinel Cohort: RSV 240 mcg Age 18-49 Years	Sentinel Cohort: Placebo Age 18-49 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years	Sentinel Cohort: RSV 120 mcg Age 50-85 Years	Sentinel Cohort: RSV 240 mcg 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 Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years:	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV 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 Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV 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 Placebo and SIIV 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 Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV 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 Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV 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 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 Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years:	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Myocardial infarctionCardiac disorders	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	0/41	0/41	0/41	0/41	0/42	0/40	1/41	0/41	0/43	0/42	0/40	0/41	0/41	0/41	0/41	0/40	0/40	0/40	0/41	0/40	0/42	0/41
GastroenteritisInfections and infestations	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	0/41	0/41	0/41	0/41	0/42	0/40	0/41	0/41	0/43	0/42	0/40	0/41	0/41	0/41	0/41	0/40	0/40	0/40	0/41	0/40	0/42	0/41
OsteoarthritisMusculoskeletal and connective tissue disorders	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	1/12	0/12	0/41	0/41	0/41	0/41	0/41	0/41	0/41	1/41	0/42	0/40	1/41	0/41	0/43	0/42	0/40	0/41	0/41	0/41	0/41	0/40	1/40	0/40	0/41	0/40	0/42	0/41
Atrial fibrillationCardiac disorders	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/41	0/41	0/41	0/41	0/41	0/41	0/41	0/41	0/42	0/40	0/41	0/41	1/43	0/42	0/40	0/41	0/41	0/41	0/41	0/40	2/40	0/40	0/41	0/40	1/42	0/41
Chest painGeneral disorders	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/41	0/41	0/41	0/41	0/41	0/41	0/41	0/41	0/42	1/40	0/41	0/41	1/43	0/42	0/40	0/41	0/41	0/41	0/41	0/40	0/40	0/40	0/41	0/40	1/42	0/41
PyrexiaGeneral disorders	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/41	0/41	0/41	0/41	0/41	0/41	0/41	0/41	0/42	0/40	0/41	0/41	0/43	0/42	1/40	0/41	0/41	0/41	0/41	0/40	0/40	0/40	0/41	0/40	0/42	0/41
Colitis ischaemicGastrointestinal disorders	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/41	0/41	0/41	0/41	0/41	0/41	0/41	0/41	0/42	0/40	0/41	0/41	0/43	0/42	0/40	0/41	0/41	0/41	0/41	0/40	0/40	1/40	0/41	0/40	0/42	0/41
Pneumonia bacterialInfections and infestations	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/41	0/41	0/41	0/41	0/41	0/41	0/41	0/41	0/42	0/40	0/41	0/41	0/43	0/42	0/40	0/41	0/41	0/41	0/41	0/40	0/40	1/40	0/41	0/40	0/42	0/41
ContusionInjury, poisoning and procedural complications	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/41	0/41	0/41	0/41	0/41	0/41	0/41	0/41	0/42	0/40	0/41	0/41	0/43	0/42	0/40	0/41	0/41	0/41	0/41	0/40	0/40	0/40	0/41	1/40	0/42	0/41
Rib fractureInjury, poisoning and procedural complications	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/41	0/41	0/41	0/41	0/41	0/41	0/41	0/41	0/42	1/40	0/41	0/41	0/43	0/42	0/40	0/41	0/41	0/41	0/41	0/40	0/40	0/40	0/41	0/40	0/42	0/41

Most frequent other events

Showing 10 of 152

Most frequent other events
Event	Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years	Sentinel Cohort: RSV 120 mcg Age 18-49 Years	Sentinel Cohort: RSV 240 mcg Age 18-49 Years	Sentinel Cohort: Placebo Age 18-49 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years	Sentinel Cohort: RSV 120 mcg Age 50-85 Years	Sentinel Cohort: RSV 240 mcg 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 Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years:	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV 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 Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV 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 Placebo and SIIV 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 Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV 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 Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV 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 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 Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years:	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Injection site pain (PAIN AT INJECTION SITE)General disorders	6/12	3/12	2/11	2/12	3/12	5/12	2/12	9/12	10/12	8/12	2/12	1/12	1/12	0/12	19/41	28/41	19/41	25/41	27/41	30/41	10/41	4/40	10/42	5/40	8/41	16/41	16/43	16/42	21/40	21/41	27/40	24/41	30/41	11/40	11/40	9/40	12/41	17/40	17/42	2/40
Headache (HEADACHE)Nervous system disorders	5/12	3/12	7/11	1/12	3/12	3/12	1/12	5/12	5/12	5/12	1/12	1/12	3/12	1/12	18/41	16/41	21/41	19/41	26/41	21/41	17/41	5/40	7/42	7/40	10/41	12/41	16/43	23/42	18/40	20/41	19/40	19/41	20/41	10/40	5/40	7/40	4/41	11/40	15/42	10/40
Myalgia (MUSCLE PAIN)Musculoskeletal and connective tissue disorders	6/12	4/12	2/11	1/12	4/12	6/12	4/12	4/12	6/12	7/12	4/12	1/12	2/12	1/12	17/41	23/41	14/41	25/41	19/41	23/41	9/41	6/40	7/42	5/40	11/41	16/41	11/43	13/42	15/40	17/41	21/40	19/41	26/41	7/40	6/40	9/40	8/41	18/40	18/42	5/40
Fatigue (FATIGUE)General disorders	5/12	5/12	6/11	3/12	7/12	4/12	3/12	6/12	7/12	7/12	5/12	4/12	1/12	4/12	20/41	17/41	16/41	18/41	21/41	24/41	18/41	10/40	16/42	8/40	13/41	12/41	16/43	19/42	16/40	15/41	20/40	25/41	20/41	8/40	11/40	9/40	14/41	20/40	21/42	8/40
Diarrhoea (DIARRHEA)Gastrointestinal disorders	1/12	2/12	3/11	1/12	0/12	1/12	2/12	3/12	2/12	1/12	0/12	2/12	4/12	1/12	6/41	10/41	10/41	8/41	11/41	9/41	6/41	7/40	5/42	2/40	6/41	5/41	7/43	10/42	7/40	10/41	10/40	11/41	14/41	3/40	9/40	4/40	4/41	10/40	8/42	6/40
Arthralgia (JOINT PAIN)Musculoskeletal and connective tissue disorders	1/12	2/12	2/11	1/12	4/12	4/12	2/12	1/12	2/12	2/12	2/12	0/12	1/12	1/12	8/41	11/41	8/41	10/41	11/41	9/41	5/41	7/40	8/42	6/40	8/41	7/41	6/43	5/42	2/40	5/41	12/40	11/41	9/41	8/40	4/40	6/40	5/41	6/40	14/42	7/40
Nausea (NAUSEA)Gastrointestinal disorders	4/12	2/12	2/11	0/12	1/12	1/12	2/12	0/12	2/12	3/12	2/12	2/12	1/12	0/12	6/41	8/41	6/41	5/41	12/41	4/41	8/41	4/40	1/42	2/40	8/41	6/41	3/43	6/42	6/40	11/41	9/40	7/41	10/41	2/40	1/40	2/40	4/41	7/40	5/42	3/40
Injection site swelling (SWELLING)General disorders	0/12	0/12	0/11	0/12	0/12	0/12	0/12	1/12	1/12	1/12	0/12	0/12	0/12	0/12	2/41	0/41	2/41	1/41	5/41	4/41	0/41	2/40	2/42	2/40	1/41	4/41	5/43	4/42	1/40	4/41	2/40	2/41	10/41	3/40	0/40	3/40	1/41	4/40	5/42	1/40
Vomiting (VOMITING)Gastrointestinal disorders	1/12	0/12	2/11	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	1/12	0/12	0/12	1/41	1/41	3/41	1/41	2/41	3/41	1/41	2/40	0/42	0/40	3/41	1/41	1/43	0/42	1/40	1/41	1/40	1/41	4/41	0/40	0/40	0/40	0/41	2/40	0/42	1/40
Injection site erythema (REDNESS)General disorders	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	0/12	2/12	0/12	1/12	0/12	1/41	0/41	1/41	2/41	3/41	4/41	1/41	2/40	4/42	3/40	1/41	6/41	3/43	3/42	1/40	2/41	3/40	2/41	6/41	3/40	1/40	3/40	2/41	2/40	1/42	0/40

Baseline characteristics

Safety analysis set included all participants in the sentinel and expanded cohorts who received at least 1 dose of the investigational products.

Age, Continuous
Age, Continuous(Years)	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
Mean	32.2 ± 9.5	34.0 ± 9.0	34.8 ± 8.0	34.2 ± 8.7	43.3 ± 4.8	36.3 ± 8.4	35.2 ± 9.4	65.4 ± 9.9	66.3 ± 9.7	63.7 ± 7.4	62.6 ± 8.6	62.1 ± 9.8	61.3 ± 7.7	61.3 ± 9.8	33.4 ± 8.2	32.6 ± 9.1	33.0 ± 8.6	34.1 ± 9.3	34.1 ± 8.5	36.8 ± 8.8	34.1 ± 8.7	33.1 ± 9.4	36.2 ± 8.9	34.7 ± 8.9	33.9 ± 8.5	34.6 ± 7.7	33.6 ± 8.5	72.6 ± 5.9	71.9 ± 4.8	72.4 ± 5.6	72.8 ± 5.1	70.9 ± 5.5	71.7 ± 5.4	72.2 ± 4.7	71.3 ± 4.8	72.3 ± 5.0	71.6 ± 5.2	71.4 ± 5.1	70.7 ± 4.9	70.9 ± 4.7	52.47 ± 19.68

Sex: Female, Male
Sex: Female, Male(Participants)	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
Female	7	10	6	10	9	9	5	7	8	7	5	10	9	6	27	28	27	25	29	29	26	25	29	29	28	29	29	17	23	20	25	24	22	22	23	26	26	26	20	29	771
Male	5	2	6	2	3	3	7	5	4	5	7	2	3	6	14	14	14	15	12	12	15	16	12	12	13	12	12	23	18	20	17	16	18	19	18	14	15	16	23	12	462

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	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
Hispanic or Latino	0	1	2	1	1	1	2	0	2	1	1	2	1	0	4	5	7	5	4	7	6	5	3	5	6	4	3	2	1	2	1	3	3	4	3	1	5	2	1	5	112
Not Hispanic or Latino	12	10	10	11	11	11	8	12	10	11	11	10	10	12	37	37	34	35	37	34	35	36	38	36	35	36	38	38	39	38	41	37	37	37	37	39	36	40	40	36	1112
Unknown or Not Reported	0	1	0	0	0	0	2	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	1	0	0	0	2	0	9

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	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
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	1	0	1	1	0	0	0	0	0	1	1	0	0	0	0	0	1	0	1	0	0	0	0	0	1	10
Asian	0	0	0	1	0	1	2	0	1	1	0	0	0	1	1	1	0	2	1	0	0	3	1	0	0	1	1	1	1	0	0	1	0	0	1	0	0	0	1	0	23
Native Hawaiian or Other Pacific Islander	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	4
Black or African American	2	4	2	2	1	4	0	2	0	1	4	3	1	2	10	7	8	8	6	8	9	8	13	7	7	9	9	4	6	1	5	3	3	2	6	5	3	3	6	4	188
White	10	7	10	8	10	7	9	9	11	9	7	8	9	8	30	32	32	28	31	31	30	29	27	32	30	28	29	35	34	38	36	34	37	37	33	35	37	39	36	36	978
More than one race	0	1	0	1	0	0	0	1	0	1	0	1	2	0	0	1	0	1	2	1	0	1	0	1	1	1	2	0	0	0	1	0	0	0	0	0	1	0	0	0	20
Unknown or Not Reported	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	1	2	0	0	0	1	1	0	0	0	0	0	1	0	1	1	0	0	0	0	0	10

Study locations

40 sites

Coastal Clinical Research, Inc.
Mobile, Alabama 36608, United States
Anaheim Clinical Trials
Anaheim, California 92801, United States
Paradigm Clinical Research Centers, Inc.
La Mesa, California 91942, United States
Paradigm Clinical Research Center
Redding, California 96001, United States
Clinical Research of South Florida
Coral Gables, Florida 33134, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801, United States
Meridian Clinical Research
Savannah, Georgia 31406, United States
Clinical Research Atlanta
Stockbridge, Georgia 30281, United States
East-West Medical Research Institute
Honolulu, Hawaii 96814, United States
Meridian Clinical Research Dakota Dunes
Sioux City, Iowa 51106, United States
Augusta Family Practice
Augusta, Kansas 67010, United States
Heartland Research Associates, LLC
Augusta, Kansas 67010, United States
Axtell Clinic, P.A.
Newton, Kansas 67114, United States
Heartland Research Associates, LLC
Newton, Kansas 67114, United States
Heartland Research Associates, LLC
Wichita, Kansas 67207, United States
Sundance Clinical Research, LLC
Saint Louis, Missouri 63141, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska 68701, United States
Quality Clinical Research, Inc.
Omaha, Nebraska 68114, United States
United Medical Associates
Binghamton, New York 13901, United States
Regional Clinical Research, Inc.
Endwell, New York 13760, United States
Rochester Regional Health/Rochester General Hospital
Rochester, New York 14621, United States
University of Rochester Medical Center
Rochester, New York 14642, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina 28209, United States
PMG Research of Raleigh
Raleigh, North Carolina 27609, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina 28401, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina 27103, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio 45219, United States
Aventiv Research Inc.
Columbus, Ohio 43213, United States
PriMed Clinical Research
Dayton, Ohio 45419, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma 73112, United States
Benchmark Research
Austin, Texas 78705, United States
Texas Health Care, PLLC
Fort Worth, Texas 76104, United States
Ventavia Research Group, LLC
Fort Worth, Texas 76104, United States
Benchmark Research
Fort Worth, Texas 76135, United States
HealthFirst Medical Group
Fort Worth, Texas 76135, United States
Clinical Trials of Texas, LLC
San Antonio, Texas 78229, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah 84109, United States
J. Lewis Research, Inc. /Foothill Family Clinic South
Salt Lake City, Utah 84121, United States
J.Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah 84095, United States
Advanced Clinical Research
West Jordan, Utah 84088, United States

References and documents

Publications

Walsh EE, Falsey AR, Scott DA, Gurtman A, Zareba AM, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Radley D, Gomme E, Cooper D, Schmoele-Thoma B. A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. J Infect Dis. 2022 Apr 19;225(8):1357-1366. doi: 10.1093/infdis/jiab612. PubMed 34932102 ↗
Falsey AR, Walsh EE, Scott DA, Gurtman A, Zareba A, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Jiang Q, Gomme E, Cooper D, Schmoele-Thoma B. Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine. J Infect Dis. 2022 Jun 15;225(12):2056-2066. doi: 10.1093/infdis/jiab611. PubMed 34931667 ↗

Study documents

Study protocol · Jun 11, 2019
Statistical analysis plan · Jun 15, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03529773
Lead sponsor: Pfizer
Responsible party: Sponsor
First posted: May 18, 2018
Start date: Apr 18, 2018
Primary completion: Nov 20, 2019
Completion: Dec 28, 2020
Results posted: Mar 4, 2021
Last update: Mar 3, 2022

Study contacts

Pfizer CT.gov Call Center

study director · Pfizer

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults

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