Respiratory Tract Infection
Conditions
Keywords
Respiratory tract infection, RSV, Adjuvant, vaccine
Brief summary
The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with seasonal inactivated influenza vaccine (SIIV) and may evaluate a second dose of RSV vaccine administered12 months after the initial dose. In addition the study will evaluate a 2-dose regimen administered 2 months apart to 62 subjects.
Detailed description
The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with SIIV. Healthy male and female subjects between 65 to 85 years of age will be enrolled. Subjects will receive 2 intramuscular injections to assess the concomitant administration of SIIV when given to subjects receiving one of the 3 RSV vaccine dose-level candidates formulated with or without an adjuvant. If interim support implementation of revaccination, invited, consenting subjects will be revaccinated with the same dose and formulation of the RSV vaccine or placebo received at Visit 1, concomitantly with SIIV. The safety, tolerability, and immunogenicity of the second dose will be evaluated through 12 months after revaccination. 62 subjects will be randomized 1:1 to receive a dose of high dose adjuvanted RSV vaccine or placebo followed by a second dose 2 months later. Safety, tolerability, and immunogenicity will be evaluated. The subjects will be enrolled before the influenza season. There will be no concomitant SIIV administration.
Interventions
BIOLOGICALFormulation A
RSV vaccine
BIOLOGICALFormulation B
Adjuvanted RSV vaccine
BIOLOGICALFormulation C
RSV vaccine
BIOLOGICALPlacebo
Placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Observer blind
Intervention model description
Parallel
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study. 2. Healthy adults who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. 3. Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures. 4. Male and nonchildbearing-potential female adults aged 65 to 85 years at the time of enrollment (signing of the ICD). 5. Subjects must have received the primary vaccination (RSV vaccine or placebo) at Visit 1 and have signed and dated the ICD for participating in the revaccination stage (applies to Primary Study Cohort - Stage 2 subjects).
Exclusion criteria
1. 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. 2. Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation. 3. Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV). 4. Previous vaccination with any licensed or investigational RSV vaccine before enrollment into the study, or planned receipt throughout the study of nonstudy RSV vaccine. 5. Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration (applies to Primary Study Cohort - Stages 1 and 2). 6. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product(s), including natural rubber latex. In addition, a history of severe allergic reaction (eg, anaphylaxis) to any substance, including documented allergy to egg proteins (egg or egg products) or chicken proteins. 7. Subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 8. 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.Inhaled/nebulized, intra-articular, intrabursal, or topical (epidural, skin or eyes) corticosteroids are permitted. 9. 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 syndrome, idiopathic thrombocytopenic purpura, autoimmune glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1). 10. Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study. 11. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 12. Female subjects of childbearing potential or who are pregnant or breastfeeding; fertile male subjects who are unwilling to use a highly effective method of contraception for at least 28 days after the last dose of investigational product. 13. 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. 14. Planned donation of blood volumes of approximately 470 mL within 12 weeks after Vaccination 1 (applies to subjects having additional blood drawn for cellular assays).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Within 14 days after Vaccination 1 | Local reactions included redness, swelling, and pain at the injection site (left arm) recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units (range: 1 to 20, and greater than \[\>\] 21). 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 activity), moderate (interferes with activity) and severe (prevented daily activity). |
| Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Within 14 days after Vaccination 1 | Systemic events included fever, fatigue/tiredness, headache, vomiting, nausea, diarrhea, muscle pain and joint pain recorded by participants in an e-diary. Fever was graded as: mild (38.0 to 38.4 degrees \[deg\] Celsius \[C\]), moderate (38.5 to 38.9 deg C), severe (39 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle 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 (1-2 times in 24 hours \[h\]), moderate (\>2 times in 24h) and severe (required intravenous hydration). Diarrhea was graded as: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24h) and severe (6 or more loose stools in 24h). |
| Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | Within 1 month after Vaccination 1 | An AE is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. AEs included both serious and non-serious adverse events. |
| Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | Up to 12 months after Vaccination 1 | An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. A SAE is any untoward medical occurrence at any dose: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | Before vaccination and 1 Month after Vaccination 1 | GMTs of RSV A and RSV B antigens were measured using neutralizing assay. Titers above the lower limit of quantitation (LLOQ) were considered accurate and their quantitated values were reported. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5 × LLOQ. |
| Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Before vaccination and 1 Month after Vaccination 1 | The HAI and neutralizing titer LLOQ value for each strain was 1:10. Assay results below the LLOQ were set to 0.5 × LLOQ. The analysis was performed on following strains: H1N1 A/Michigan, H3N2 A/Brisbane, B/Phuket for HAI and H3N2/Brisbane for neutralizing assay. |
Countries
Australia, United States
Participant flow
Pre-assignment details
This study was conducted in 2 Cohorts: Primary Cohort (Single administration of RSVpreF formulations or placebo, co-administered with seasonal inactivated influenza vaccine \[SIIV\]), and Month-0, Month-2 Cohort (two doses of an RSVpreF formulation or placebo administered two months apart).
Participants by arm
| Arm | Count |
|---|---|
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al\[OH\]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12. | 32 |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12. | 32 |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12. | 32 |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12. | 31 |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12. | 31 |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12. | 30 |
| Primary Cohort: RSVpreF 240 mcg + SIIV Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12. | 32 |
| Primary Cohort: Placebo + SIIV Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12. | 30 |
| Month-0, Month-2 Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2. | 32 |
| Month-0, Month-2 Cohort: Placebo Participants were administered an intramuscular dose of placebo as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2. | 31 |
| Total | 313 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | No Longer Meets Eligibility Criteria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Randomized But Not Treated | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 1 | 0 | 0 |
| Overall Study | Study Terminated By Sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 29 | 27 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Placebo + SIIV | Month-0, Month-2 Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 | Month-0, Month-2 Cohort: Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Mean | 71.2 years STANDARD_DEVIATION 4.8 | 71.0 years STANDARD_DEVIATION 4.8 | 71.2 years STANDARD_DEVIATION 5.4 | 72.3 years STANDARD_DEVIATION 4.5 | 70.2 years STANDARD_DEVIATION 4.3 | 71.4 years STANDARD_DEVIATION 5.3 | 70.2 years STANDARD_DEVIATION 3.5 | 70.4 years STANDARD_DEVIATION 5.4 | 70.8 years STANDARD_DEVIATION 4.5 | 72.2 years STANDARD_DEVIATION 4.4 | 72.6 years STANDARD_DEVIATION 5.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 312 Participants | 32 Participants | 32 Participants | 32 Participants | 31 Participants | 30 Participants | 30 Participants | 32 Participants | 30 Participants | 32 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 23 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 3 Participants | 4 Participants | 4 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Unknown or Not Reported | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 285 Participants | 30 Participants | 30 Participants | 29 Participants | 29 Participants | 29 Participants | 27 Participants | 26 Participants | 25 Participants | 31 Participants | 29 Participants |
| Sex: Female, Male Female | 145 Participants | 12 Participants | 17 Participants | 17 Participants | 16 Participants | 13 Participants | 11 Participants | 12 Participants | 14 Participants | 16 Participants | 17 Participants |
| Sex: Female, Male Male | 168 Participants | 20 Participants | 15 Participants | 15 Participants | 15 Participants | 18 Participants | 19 Participants | 20 Participants | 16 Participants | 16 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 | 0 / 32 | 0 / 31 | 0 / 31 | 1 / 30 | 0 / 32 | 0 / 30 | 0 / 32 | 0 / 31 |
| other Total, other adverse events | 17 / 32 | 17 / 32 | 21 / 32 | 21 / 31 | 17 / 31 | 12 / 30 | 25 / 32 | 14 / 30 | 28 / 32 | 23 / 31 |
| serious Total, serious adverse events | 2 / 32 | 4 / 32 | 4 / 32 | 4 / 31 | 5 / 31 | 4 / 30 | 4 / 32 | 3 / 30 | 6 / 32 | 5 / 31 |
Outcome results
Primary
Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1
An AE is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. AEs included both serious and non-serious adverse events.
Time frame: Within 1 month after Vaccination 1
Population: Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1. Data for this outcome measure was planned to be collected for Primary cohort only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | 21.9 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | 21.9 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | 34.4 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | 29.0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | 25.8 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | 23.3 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | 21.9 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | 16.7 percentage of participants |
Primary
Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1
Local reactions included redness, swelling, and pain at the injection site (left arm) recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units (range: 1 to 20, and greater than \[\>\] 21). 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 activity), moderate (interferes with activity) and severe (prevented daily activity).
Time frame: Within 14 days after Vaccination 1
Population: Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Primary cohort only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Mild | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Mild | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Mild | 32.3 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Mild | 28.1 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Moderate | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Mild | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Mild | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Mild | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Mild | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Mild | 25.8 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Mild | 22.6 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Mild | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Severe | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Mild | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Mild | 16.7 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Mild | 18.8 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Moderate | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Mild | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Severe | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Severe | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Severe | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Mild | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Severe | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Mild | 3.3 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Moderate | 3.3 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Swelling: Moderate | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Pain at Injection Site: Mild | 6.7 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1 | Redness: Moderate | 0 percentage of participants |
Primary
Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. A SAE is any untoward medical occurrence at any dose: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.
Time frame: Up to 12 months after Vaccination 1
Population: Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1. Data for this outcome measure was planned to be collected for Primary cohort only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | MAEs | 46.9 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | SAEs | 6.3 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | MAEs | 59.4 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | SAEs | 12.5 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | MAEs | 46.9 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | SAEs | 12.5 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | MAEs | 51.6 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | SAEs | 12.9 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | MAEs | 54.8 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | SAEs | 16.1 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | MAEs | 60.0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | SAEs | 13.3 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | SAEs | 12.5 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | MAEs | 50.0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | MAEs | 50.0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1 | SAEs | 10.0 percentage of participants |
Primary
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Systemic events included fever, fatigue/tiredness, headache, vomiting, nausea, diarrhea, muscle pain and joint pain recorded by participants in an e-diary. Fever was graded as: mild (38.0 to 38.4 degrees \[deg\] Celsius \[C\]), moderate (38.5 to 38.9 deg C), severe (39 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle 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 (1-2 times in 24 hours \[h\]), moderate (\>2 times in 24h) and severe (required intravenous hydration). Diarrhea was graded as: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24h) and severe (6 or more loose stools in 24h).
Time frame: Within 14 days after Vaccination 1
Population: Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Primary cohort only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Mild | 16.1 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Mild | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Mild | 9.7 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Mild | 9.7 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Mild | 9.7 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | FatigueTtiredness: Mild | 16.1 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Moderate | 6.5 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Moderate | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Moderate | 6.3 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | FatigueTtiredness: Mild | 15.6 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Mild | 6.3 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Mild | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Moderate | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Moderate | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Moderate | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Mild | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Mild | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Mild | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Moderate | 9.4 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Mild | 6.3 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Mild | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Moderate | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Mild | 6.3 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Moderate | 18.8 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Mild | 9.4 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Moderate | 6.3 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Mild | 9.4 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | FatigueTtiredness: Mild | 9.4 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Severe | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Moderate | 25.8 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Moderate | 9.7 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Mild | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | FatigueTtiredness: Mild | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Mild | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Mild | 6.5 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Mild | 9.7 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Moderate | 6.5 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Mild | 6.5 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Mild | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | FatigueTtiredness: Mild | 16.1 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Mild | 12.9 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Moderate | 3.2 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | FatigueTtiredness: Mild | 3.3 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Mild | 10.0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Moderate | 6.7 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Mild | 10.0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Moderate | 10.0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Mild | 16.7 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Mild | 6.7 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Severe | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | FatigueTtiredness: Mild | 31.3 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Mild | 6.3 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Moderate | 9.4 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Severe | 3.1 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Mild | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Mild | 12.5 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Moderate | 6.3 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Mild | 6.3 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Mild | 9.4 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Moderate | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Severe | 0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Mild | 25.0 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Moderate | 9.4 percentage of participants |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Severe | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Severe | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Moderate | 3.3 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Mild | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Severe | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Moderate | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Moderate | 3.3 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Moderate | 6.7 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Mild | 10.0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Moderate | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Severe | 00 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fever: Moderate | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Mild | 6.7 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Diarrhea: Severe | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Moderate | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Mild | 16.7 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Mild | 6.7 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Muscle Pain: Moderate | 3.3 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Severe | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Nausea: Mild | 10.0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Headache: Severe | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Vomiting: Mild | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Joint Pain: Severe | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | Fatigue/Tiredness: Severe | 0 percentage of participants |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1 | FatigueTtiredness: Mild | 16.7 percentage of participants |
Secondary
Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. Titers above the lower limit of quantitation (LLOQ) were considered accurate and their quantitated values were reported. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5 × LLOQ.
Time frame: Before vaccination and 1 Month after Vaccination 1
Population: Evaluable immunogenicity population: eligible participants who received both SIIV and RSV vaccinations or SIIV and placebo as randomized, had blood drawn within 27-42 days after Visit 1 pre-specified time frames at 1-month post-vaccination follow-up visit, had at least 1 valid, determinate assay result for proposed analysis, had no major protocol violations. Number Analyzed= participants evaluable for each row. Data for this outcome measure was planned to be collected for Primary cohort only.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: 1 Month After Vaccination 1 | 15158 titers |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: 1 Month After Vaccination 1 | 15182 titers |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: Before Vaccination 1 | 2113 titers |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: Before Vaccination 1 | 1786 titers |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: Before Vaccination 1 | 2592 titers |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: Before Vaccination 1 | 2116 titers |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: 1 Month After Vaccination 1 | 9694 titers |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: 1 Month After Vaccination 1 | 12385 titers |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: Before Vaccination 1 | 1728 titers |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: Before Vaccination 1 | 2234 titers |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: 1 Month After Vaccination 1 | 17806 titers |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: 1 Month After Vaccination 1 | 14436 titers |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: Before Vaccination 1 | 2395 titers |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: 1 Month After Vaccination 1 | 12781 titers |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: Before Vaccination 1 | 2021 titers |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: 1 Month After Vaccination 1 | 15492 titers |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: Before Vaccination 1 | 1884 titers |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: Before Vaccination 1 | 2333 titers |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: 1 Month After Vaccination 1 | 18205 titers |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: 1 Month After Vaccination 1 | 18045 titers |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: Before Vaccination 1 | 1844 titers |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: Before Vaccination 1 | 2061 titers |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: 1 Month After Vaccination 1 | 20777 titers |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: 1 Month After Vaccination 1 | 23929 titers |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: Before Vaccination 1 | 2243 titers |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: Before Vaccination 1 | 1580 titers |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: 1 Month After Vaccination 1 | 22249 titers |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: 1 Month After Vaccination 1 | 23833 titers |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: Before Vaccination 1 | 1677 titers |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: 1 Month After Vaccination 1 | 1823 titers |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV B: 1 Month After Vaccination 1 | 1617 titers |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1 | RSV A: Before Vaccination 1 | 2093 titers |
Secondary
Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1
The HAI and neutralizing titer LLOQ value for each strain was 1:10. Assay results below the LLOQ were set to 0.5 × LLOQ. The analysis was performed on following strains: H1N1 A/Michigan, H3N2 A/Brisbane, B/Phuket for HAI and H3N2/Brisbane for neutralizing assay.
Time frame: Before vaccination and 1 Month after Vaccination 1
Population: Evaluable immunogenicity population: participants who received both SIIV and RSV vaccinations or SIIV and placebo as randomized, had blood drawn within 27-42 days after Visit 1 pre-specified time frames at 1-month post-vaccination follow-up visit, had at least 1 valid, determinate assay result for analysis, had no major protocol violations. Number Analyzed = participants evaluable for each specified row. Data for this outcome was planned to be collected for Primary cohort only.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: Before Vaccination 1 | 121.6 titers |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: 1 Month After Vaccination 1 | 121.5 titers |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: Before Vaccination 1 | 47.9 titers |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: 1 Month After Vaccination 1 | 297.9 titers |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: Before Vaccination 1 | 8.7 titers |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: 1 Month After Vaccination 1 | 12.3 titers |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: Before Vaccination 1 | 12.4 titers |
| Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: 1 Month After Vaccination 1 | 27.3 titers |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: Before Vaccination 1 | 8.4 titers |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: Before Vaccination 1 | 143.9 titers |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: 1 Month After Vaccination 1 | 11.2 titers |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: Before Vaccination 1 | 15.5 titers |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: Before Vaccination 1 | 42.8 titers |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: 1 Month After Vaccination 1 | 372.4 titers |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: 1 Month After Vaccination 1 | 114.4 titers |
| Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: 1 Month After Vaccination 1 | 27.4 titers |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: Before Vaccination 1 | 10.2 titers |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: Before Vaccination 1 | 6.6 titers |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: 1 Month After Vaccination 1 | 19.1 titers |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: Before Vaccination 1 | 57.8 titers |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: 1 Month After Vaccination 1 | 10.2 titers |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: 1 Month After Vaccination 1 | 238.9 titers |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: Before Vaccination 1 | 29.5 titers |
| Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: 1 Month After Vaccination 1 | 102.1 titers |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: 1 Month After Vaccination 1 | 21.4 titers |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: 1 Month After Vaccination 1 | 141.5 titers |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: Before Vaccination 1 | 35.8 titers |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: 1 Month After Vaccination 1 | 251.6 titers |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: Before Vaccination 1 | 80.9 titers |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: Before Vaccination 1 | 7.9 titers |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: 1 Month After Vaccination 1 | 12.2 titers |
| Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: Before Vaccination 1 | 9.3 titers |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: 1 Month After Vaccination 1 | 327.2 titers |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: Before Vaccination 1 | 12.4 titers |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: Before Vaccination 1 | 102.3 titers |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: Before Vaccination 1 | 37.2 titers |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: 1 Month After Vaccination 1 | 22.1 titers |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: Before Vaccination 1 | 8.6 titers |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: 1 Month After Vaccination 1 | 14.4 titers |
| Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: 1 Month After Vaccination 1 | 143.9 titers |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: 1 Month After Vaccination 1 | 21.2 titers |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: 1 Month After Vaccination 1 | 100.4 titers |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: Before Vaccination 1 | 90.7 titers |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: Before Vaccination 1 | 31.9 titers |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: Before Vaccination 1 | 10.1 titers |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: 1 Month After Vaccination 1 | 14.7 titers |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: Before Vaccination 1 | 7.3 titers |
| Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: 1 Month After Vaccination 1 | 258.1 titers |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: Before Vaccination 1 | 121.7 titers |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: 1 Month After Vaccination 1 | 118.3 titers |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: 1 Month After Vaccination 1 | 286.2 titers |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: Before Vaccination 1 | 9.1 titers |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: 1 Month After Vaccination 1 | 15.5 titers |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: 1 Month After Vaccination 1 | 21.9 titers |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: Before Vaccination 1 | 12.2 titers |
| Primary Cohort: RSVpreF 240 mcg + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: Before Vaccination 1 | 38.3 titers |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: 1 Month After Vaccination 1 | 26.7 titers |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: 1 Month After Vaccination 1 | 15.2 titers |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: B/Phuket: Before Vaccination 1 | 7.5 titers |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: 1 Month After Vaccination 1 | 321.8 titers |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H3N2 A/Brisbane: Before Vaccination 1 | 76.8 titers |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: 1 Month After Vaccination 1 | 149.3 titers |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | HAI: H1N1 A/Michigan: Before Vaccination 1 | 35.4 titers |
| Primary Cohort: Placebo + SIIV | Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1 | Neutralizing assay: H3N2/Brisbane: Before Vaccination 1 | 8.7 titers |