Healthy
Conditions
Keywords
Flu, Influenza, Vaccine, RNA vaccine, RSV, Respiratory Syncytial Virus, Combination vaccine, Vaccine osmolality
Brief summary
Substudy A: The study aims to learn about the safety and effects of two new vaccines for RSV (RSVpreF) and influenza (modRNA qIRV) when given as a single shot compared to when given separately. RSV and influenza lead to infections, mainly in the fall and winter. These vaccines are being developed to help prevent respiratory syncytial virus (RSV) and influenza (Flu) disease. This study is seeking participants who: * are 60 years or older * are healthy or have well-controlled chronic conditions * have not had a flu shot in the last 120 days * and agree to be present for all study visits, procedures, and blood draws. The participants will be divided into 2 groups. Group 1 will receive RSVpreF plus qIRV combo shot, after which participants will receive the placebo (a shot which has no medicine). Group 2 will receive shots for qIRV first and then RSVpreF 1 month apart. The investigators will examine the experiences of the participants receiving the study vaccines. This will help the investigators determine if the study vaccines are safe and produce a similar immune response. Participants will be involved in this study for 2 months. During this time, participants will have 3 visits at the study clinic. Substudy B will investigate 2 formulations of RSVpreF + qIRV of different volumes and osmolaities (concentrations). These formulations will be examined for safety, tolerability, and immunogenicity, with the goal of selecting a formulation for further study. This study is seeking participants who: * are 50 years or older * are healthy or have well-controlled chronic conditions * have not had a flu shot in the last 180 days * and agree to be present for all study visits, procedures, and blood draws. The participants will be divided into 2 groups. Group 1 will receive RSVpreF plus qIRV in a 1.0-mL formulation while Group 2 will receive RSVpreF plus qIRV in a 0.5-mL formulation. The investigators will examine the experiences of the participants receiving the study vaccines. This will help the investigators determine if the study vaccines are safe, well tolerated and produce a similar immune response. Participants will be involved in this study for 1 month. During this time, participants will have 2 visits at the study clinic.
Detailed description
Substudy A: This study is designed to evaluate the safety, tolerability, and immunogenicity of respiratory combination vaccine candidates. This initial study will be conducted as a Phase 1b, parallel-group, randomized, placebo-controlled, observer-blinded substudy of RSVpreF and a nucleoside-modified RNA vaccine (qIRV) against RSV and influenza when administered as a combined vaccine and when administered alone. Healthy adults ≥60 years of age will be randomized 1:1 to either Group 1: combination (RSVpreF + qIRV) followed by placebo; or Group 2: sequential administration of qIRV followed by RSVpreF administered 1 month apart. Substudy B will be conducted as a Phase 1b, parallel-group, randomized, observer-blinded substudy of RSVpreF and a nucleoside-modified RNA vaccine (qIRV) against RSV and influenza administered as a combined vaccine in a 1.0-mL formulation and when administered in a 0.5-mL formulation. Healthy adults ≥50 years of age will be randomized 1:1 to either Group 1: combination (RSVpreF + qIRV) 1.0-mL formulation; or Group 2: combination (RSVpreF + qIRV) 0.5 mL formulation. Approximately 100 participants will be randomized within the 50- through 64-year-old group, and 100 participants ≥65 years of age will be randomized.
Interventions
BIOLOGICALRSVpreF+qIRV
RSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B combined with Quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains)
BIOLOGICALqIRV
Quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains)
BIOLOGICALRSVpreF
RSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B
DRUGPlacebo
0.9% saline for injection
BIOLOGICALRSVpreF + qIRV 1.0 mL formulation
RSVpreF containing 2 Stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B plus qIRV Encoding HA of 4 strains as recommended for the influenza season (2 A strains and 2 B strains) plus sterile water as diluent for injection
BIOLOGICALRSVpreF + qIRV 0.5 mL formulation
RSVpreF containing 2 Stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B plus qIRV Encoding HA of 4 strains as recommended for the influenza season (2 A strains and 2 B strains)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Substudy A: This is an observer-blinded study. Participants will be blinded to their assigned study intervention. The study staff receiving, storing, dispensing, preparing, and administering the study interventions will be unblinded. All other study and site personnel, including the investigator and investigator staff, will be blinded to assignment of study intervention. With the exception of the staff conducting the immunogenicity assays, the sponsor will be unblinded. Substudy B: This is an observer-blinded study. Participants will be blinded to their assigned study intervention. The study staff receiving, storing, dispensing, preparing, and administering the study interventions will be unblinded. All other study and site personnel, including the investigator and investigator staff, will be blinded to assignment of study intervention. With the exception of the staff conducting the immunogenicity assays, the sponsor will be unblinded.
Intervention model description
Substudy A: Approximately 250 healthy adults ≥60 years of age will be randomized 1:1 to either Group 1: combination (RSVpreF + qIRV) (Visit 1) followed by placebo (Visit 2); or Group 2: sequential administration of qIRV (Visit 1) followed by RSVpreF (Visit 2) administered 1 month apart. Randomization will be stratified by 3 age groups (60-64, 65-79, and ≥80 years) within each study site. Substudy B: Approximately 200 healthy adults ≥50 years of age will be randomized 1:1 to either Group 1: combination (RSVpreF + qIRV) 1.0-mL formulation; or Group 2: combination (RSVpreF + qIRV) 0.5 mL formulation. Randomization will be stratified by 6 age/sex groups (female 50-64, female 65-79, and female ≥80 years; male 50-64, male 65-79, and male ≥80 years) within the study site.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Substudy A: Inclusion Criteria: 1. Participants ≥60 years of age at study enrollment. 2. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures. 3. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. 4. Capable of giving and having signed the informed consent as described in the protocol, which includes complying with the requirements and restrictions listed in the ICD and in this protocol. 5. Receipt of licensed influenza vaccination for the 2022-2023 northern hemisphere season or 2022 southern hemisphere season \>120 days before study intervention administration.
Exclusion criteria
1. A confirmed diagnosis of RSV infection or influenza ≤120 days before study intervention administration. 2. History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 3. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate IM injection. 4. Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study. 5. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 6. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 7. Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study intervention administration, or planned receipt throughout the study. 8. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt throughout the study. 9. Receipt of any licensed RSV vaccine at any time prior to enrollment, or planned receipt throughout the study. 10. Receipt of any licensed influenza vaccine ≤120 days before study enrollment, or planned receipt throughout the study. 11. Participation in other studies involving an investigational RSV or mRNA influenza vaccine at any time prior to enrollment, and thereafter until study completion, regardless of vaccine assignment. 12. Participation in any other interventional studies within 28 days before study enrollment through study completion. 13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. Substudy B Inclusion Criteria: 1. Participants ≥50 years of age at study enrollment. 2. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures. 3. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. 4. Capable of giving and having signed the informed consent as described in the protocol, which includes complying with the requirements and restrictions listed in the ICD and in this protocol. 5. Receipt of licensed influenza vaccination for the 2022-2023 northern hemisphere season or 2022 southern hemisphere season \>180 days before study intervention administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2) | SSA- For Group 1: 1 Month after Vaccination 1 (Day 1); For Group 2: 1 Month after Vaccination 2 (1 Month after Vaccination 1) | GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of each strain neutralizing GMTs in the combination RSVpreF + qIRV group to that in the sequential-administration RSVpreF group. The analysis was performed on the influenza strains: H1N1 A/Sydney, H3N2 A/Darwin, B/Austria, and B/Phuket. |
| SSB: Percentage of Participants Reporting SAEs Throughout the Sub Study | SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination (Maximum up to 36 days) | An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. |
| SSA: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NT) for Each RSV Subgroup (A or B) 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and RSVpreF Alone (Group 2) | SSA- For Group 1: 1 Month after Vaccination 1 (Day 1); For Group 2: 1 Month after Vaccination 2 (1 Month after Vaccination 1) | GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of RSV subgroup A (RSV A) or RSV subgroup B (RSV B) neutralizing GMTs in the combination RSVpreF + qIRV group to that in the sequential-administration RSVpreF group. |
| SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | SSA: From Day 1 to Day 7 after Vaccination 1 | Local reactions included pain, redness and swelling at the injection site, recorded by participants in an electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: greater than (\>) 5.0 cm to 10.0 cm; severe: \> 10 cm. |
| SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month After Vaccination 1) | Local reactions included pain, redness and swelling at the injection site, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: \> 5.0 cm to 10.0 cm; severe: \> 10 cm. |
| SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | SSB: From Day 1 to Day 7 after Vaccination | Local reactions included pain, redness and swelling at the injection site, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: \> 5.0 cm to 10.0 cm; severe: \> 10 cm. |
| SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | SSA: From Day 1 to Day 7 after Vaccination 1 | Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature \>=38.0 degrees Celsius (deg C) and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C, severe: \>38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24 hours (h); moderate: \>2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity. |
| SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month after Vaccination 1) | Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature \>=38.0 deg C and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C, severe: \>38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24h; moderate: \>2 times in 24h; severe: required IV hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity. |
| SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | SSB: From Day 1 to Day 7 After Vaccination | Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature \>=38.0 deg C and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C, severe: \>38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24h; moderate: \>2 times in 24h; severe: required IV hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity. |
| SSA: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1 | SSA: Within 1 Month after Vaccination 1 | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included. |
| SSA: Percentage of Participants Reporting AEs Within 1 Month After Vaccination 2 | SSA: Within 1 Month after Vaccination 2 | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included. |
| SSB: Percentage of Participants Reporting AEs Throughout the Sub Study | SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included. |
| SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) Throughout the Sub Study | SSA: From Day 1 (Vaccination 1) up to 35 days of follow-up post Vaccination 2 (Maximum up to 70 days) | An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination | SSB: At 1 Month after Vaccination (Day 1) | GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of each strain neutralizing GMTs to the combination of 1 mL RSVpreF + qIRV (Group 1) and 0.5 ml of RSVpreF + qIRV (Group 2). The analysis was performed on the influenza strains: H1N1 A/Sydney, H3N2 A/Darwin, B/Austria, and B/Phuket. |
| SSB: GMT and GMR of NT for Each RSV A or RSV B 1 Month After Vaccination | SSB: At 1 Month after Vaccination (Day 1) | GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of RSV A or RSV B neutralizing GMTs in the combination of 1 mL RSVpreF + qIRV (group 1) and 0.5 ml of RSVpreF + qIRV (group 2) |
Countries
Argentina
Participant flow
Recruitment details
This study had sub-study A (SSA) and sub-study B (SSB).
Pre-assignment details
A total of 508 participants (SSA: 273 + SSB: 235) were enrolled in this study, 455 participants (SSA:251 + SSB: 204) were randomized to receive study intervention.
Participants by arm
| Arm | Count |
|---|---|
| SSA: Group 1: Combination (RSVpreF + qIRV)/ Placebo Participants aged \>= 60 years were randomized to receive 1.0 mL combination of RSVpreF and qIRV intramuscularly on Day 1 \[Vaccination 1\]. After 1 month, placebo (0.9% normal saline for injection) \[Vaccination 2\] was administered intramuscularly. Participants were followed up to maximum of 35 days after Vaccination 2. | 125 |
| SSA: Group 2: Sequential Administration qIRV/ RSVpreF Participants aged \>= 60 years were randomized to receive 1.0 mL of qIRV intramuscularly on Day 1 (Vaccination 1). After 1 month, RSVpreF (Vaccination 2) was administered intramuscularly. Participants were followed up to maximum of 35 days after Vaccination 2. | 126 |
| SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation Participants aged \>=50 years were randomized to receive 1.0 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. Participants were followed up to maximum of 35 days after Vaccination. | 101 |
| SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation Participants aged \>=50 years were randomized to receive 0.5 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. Participants were followed up to maximum of 35 days after Vaccination. | 102 |
| Total | 454 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| SSA (Approximately 2 Months) | Adverse Event | 1 | 2 | 0 | 0 |
| SSA (Approximately 2 Months) | Death | 0 | 1 | 0 | 0 |
| SSA (Approximately 2 Months) | Lost to Follow-up | 0 | 1 | 0 | 0 |
| SSA (Approximately 2 Months) | No longer met eligibility criteria | 0 | 1 | 0 | 0 |
| SSA (Approximately 2 Months) | Withdrawal by Subject | 4 | 8 | 0 | 0 |
| SSB (Approximately 1 Month) | Not Vaccinated | 0 | 0 | 1 | 0 |
| SSB (Approximately 1 Month) | Other | 0 | 0 | 0 | 1 |
| SSB (Approximately 1 Month) | Refused further study procedures | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | SSA: Group 1: Combination (RSVpreF + qIRV)/ Placebo | SSA: Group 2: Sequential Administration qIRV/ RSVpreF | SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation | SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation |
|---|---|---|---|---|---|
| Age, Customized 50-64 years | 147 Participants | 22 Participants | 23 Participants | 50 Participants | 52 Participants |
| Age, Customized 65-79 years | 282 Participants | 94 Participants | 93 Participants | 48 Participants | 47 Participants |
| Age, Customized >=80 years | 25 Participants | 9 Participants | 10 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 453 Participants | 125 Participants | 126 Participants | 101 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 454 Participants | 125 Participants | 126 Participants | 101 Participants | 102 Participants |
| Sex: Female, Male Female | 230 Participants | 62 Participants | 73 Participants | 47 Participants | 48 Participants |
| Sex: Female, Male Male | 224 Participants | 63 Participants | 53 Participants | 54 Participants | 54 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 125 | 0 / 121 | 0 / 126 | 1 / 116 | 0 / 101 | 0 / 102 |
| other Total, other adverse events | 117 / 125 | 50 / 121 | 117 / 126 | 43 / 116 | 91 / 101 | 96 / 102 |
| serious Total, serious adverse events | 0 / 125 | 0 / 121 | 1 / 126 | 1 / 116 | 2 / 101 | 0 / 102 |
Outcome results
Primary
SSA: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NT) for Each RSV Subgroup (A or B) 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and RSVpreF Alone (Group 2)
GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of RSV subgroup A (RSV A) or RSV subgroup B (RSV B) neutralizing GMTs in the combination RSVpreF + qIRV group to that in the sequential-administration RSVpreF group.
Time frame: SSA- For Group 1: 1 Month after Vaccination 1 (Day 1); For Group 2: 1 Month after Vaccination 2 (1 Month after Vaccination 1)
Population: Evaluable RSV immunogenicity population: all eligible participants who received the study intervention to which they were randomized, had the 1 month postvaccination blood collection within 27 to 42 days after vaccination, had at least 1 valid and determinate RSV NT result at the 1-month postvaccination blood collection, and had no major protocol violations from randomization through the 1 month postvaccination blood collection.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSA: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NT) for Each RSV Subgroup (A or B) 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and RSVpreF Alone (Group 2) | NT: RSV A | 16553 Titer |
| SSA: Group 1: RSVpreF + qIRV | SSA: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NT) for Each RSV Subgroup (A or B) 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and RSVpreF Alone (Group 2) | NT: RSV B | 11795 Titer |
| SSA: Group 2: qIRV | SSA: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NT) for Each RSV Subgroup (A or B) 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and RSVpreF Alone (Group 2) | NT: RSV A | 19740 Titer |
| SSA: Group 2: qIRV | SSA: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NT) for Each RSV Subgroup (A or B) 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and RSVpreF Alone (Group 2) | NT: RSV B | 14959 Titer |
Comparison: GMR for RSV A: RSVpreF + qIRV combination to RSVpreF alone.95% CI: [0.662, 1.062]
Comparison: GMR for RSV B: RSVpreF + qIRV combination to RSVpreF alone.95% CI: [0.614, 1.013]
Primary
SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2)
GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of each strain neutralizing GMTs in the combination RSVpreF + qIRV group to that in the sequential-administration RSVpreF group. The analysis was performed on the influenza strains: H1N1 A/Sydney, H3N2 A/Darwin, B/Austria, and B/Phuket.
Time frame: SSA- For Group 1: 1 Month after Vaccination 1 (Day 1); For Group 2: 1 Month after Vaccination 2 (1 Month after Vaccination 1)
Population: Evaluable HAI immunogenicity population: all eligible participants who received the study intervention to which they were randomized, and had the 1month postvaccination blood collection for HAI assay within 27-42 days after vaccination, had at least 1 valid and determinate HAI result at 1 month postvaccination blood collection, had no major protocol violations from randomization through 1 month postvaccination blood collection.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2) | HAI: H1N1 A/Wisconsin | 194 Titer |
| SSA: Group 1: RSVpreF + qIRV | SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2) | HAI: H3N2 A/Darwin | 161 Titer |
| SSA: Group 1: RSVpreF + qIRV | SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2) | HAI: B/Austria | 53 Titer |
| SSA: Group 1: RSVpreF + qIRV | SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2) | HAI: B/Phuket | 22 Titer |
| SSA: Group 2: qIRV | SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2) | HAI: B/Phuket | 24 Titer |
| SSA: Group 2: qIRV | SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2) | HAI: H1N1 A/Wisconsin | 238 Titer |
| SSA: Group 2: qIRV | SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2) | HAI: B/Austria | 56 Titer |
| SSA: Group 2: qIRV | SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2) | HAI: H3N2 A/Darwin | 219 Titer |
Comparison: GMR for HAI: H1N1 A/Wisconsin: RSVpreF + qIRV combination to RSVpreF alone.95% CI: [0.632, 1.044]
Comparison: GMR for HAI: H3N2 A/Darwin: RSVpreF + qIRV combination to RSVpreF alone.95% CI: [0.567, 0.957]
Comparison: GMR for HAI: B/Austria: RSVpreF + qIRV combination to RSVpreF alone.95% CI: [0.741, 1.181]
Comparison: GMR for HAI: B/Phuket: RSVpreF + qIRV combination to RSVpreF alone.95% CI: [0.707, 1.174]
Primary
SSA: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included.
Time frame: SSA: Within 1 Month after Vaccination 1
Population: SSA: Safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1 | 29.6 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1 | 33.3 Percentage of participants |
Primary
SSA: Percentage of Participants Reporting AEs Within 1 Month After Vaccination 2
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included.
Time frame: SSA: Within 1 Month after Vaccination 2
Population: SSA: Safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants Reporting AEs Within 1 Month After Vaccination 2 | 16.5 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants Reporting AEs Within 1 Month After Vaccination 2 | 13.8 Percentage of participants |
Primary
SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) Throughout the Sub Study
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
Time frame: SSA: From Day 1 (Vaccination 1) up to 35 days of follow-up post Vaccination 2 (Maximum up to 70 days)
Population: SSA: Safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) Throughout the Sub Study | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) Throughout the Sub Study | 2.4 Percentage of participants |
Primary
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Local reactions included pain, redness and swelling at the injection site, recorded by participants in an electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: greater than (\>) 5.0 cm to 10.0 cm; severe: \> 10 cm.
Time frame: SSA: From Day 1 to Day 7 after Vaccination 1
Population: SSA: E-diary safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone, and had at least 1 day of e-diary data transferred.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Moderate | 20.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Mild | 3.2 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Mild | 5.6 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Moderate | 3.2 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Moderate | 4.0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Severe | 0.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Mild | 49.6 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Severe | 2.4 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Mild | 52.0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Moderate | 28.0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Severe | 2.4 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Mild | 3.2 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Moderate | 4.8 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Severe | 0.8 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Mild | 6.4 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Moderate | 8.0 Percentage of participants |
Primary
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Local reactions included pain, redness and swelling at the injection site, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: \> 5.0 cm to 10.0 cm; severe: \> 10 cm.
Time frame: SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month After Vaccination 1)
Population: SSA: E-diary safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone, and had at least 1 day of e-diary data transferred.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Moderate | 1.7 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Mild | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Mild | 0.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Moderate | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Moderate | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Mild | 1.7 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Mild | 7.8 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Moderate | 0.9 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Mild | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Moderate | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Mild | 0.9 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Moderate | 0 Percentage of participants |
Primary
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature \>=38.0 degrees Celsius (deg C) and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C, severe: \>38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24 hours (h); moderate: \>2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.
Time frame: SSA: From Day 1 to Day 7 after Vaccination 1
Population: SSA: E-diary safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone, and had at least 1 day of e-diary data transferred.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Moderate | 24.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Nausea: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Moderate | 30.4 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Mild | 4.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Moderate | 1.6 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: Moderate | 6.4 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Severe | 0.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Mild | 1.6 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Mild | 15.2 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Severe | 0.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Moderate | 12.0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Moderate | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Mild | 20.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Mild | 17.6 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Moderate | 22.4 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Mild | 24.0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Nausea: Mild | 5.6 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Mild | 11.2 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: Severe | 1.6 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Moderate | 14.4 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Nausea: Moderate | 2.4 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: Mild | 4.0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Severe | 0.8 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: Mild | 12.8 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: Moderate | 4.0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: Severe | 5.6 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Mild | 20.8 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Moderate | 24.0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Severe | 4.0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Mild | 26.4 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Moderate | 11.2 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Mild | 1.6 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Moderate | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Nausea: Mild | 5.6 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Nausea: Moderate | 3.2 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Nausea: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Mild | 4.0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Moderate | 1.6 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Mild | 20.8 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Moderate | 11.2 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Mild | 20.8 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Moderate | 15.2 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Severe | 1.6 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Mild | 11.2 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Moderate | 6.4 Percentage of participants |
Primary
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature \>=38.0 deg C and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C, severe: \>38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24h; moderate: \>2 times in 24h; severe: required IV hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.
Time frame: SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month after Vaccination 1)
Population: SSA: E-diary safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone, and had at least 1 day of e-diary data transferred.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: Mild | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: Moderate | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Mild | 7.4 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Moderate | 3.3 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Mild | 10.7 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Moderate | 5.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Mild | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Moderate | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Nausea: Mild | 3.3 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Nausea: Moderate | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Nausea: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Mild | 5.0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Moderate | 1.7 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Mild | 2.5 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Moderate | 1.7 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Moderate | 1.7 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Mild | 5.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Moderate | 1.7 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Mild | 4.1 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Nausea: Moderate | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: Mild | 0.9 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: Moderate | 0.9 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Nausea: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: Severe | 0.9 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Mild | 6.1 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Mild | 2.6 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Moderate | 7.0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Mild | 4.3 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Severe | 1.7 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Moderate | 0.9 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Mild | 10.4 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Mild | 2.6 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Moderate | 6.1 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Severe | 0.9 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Moderate | 7.0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Mild | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Mild | 3.5 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Moderate | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Moderate | 6.1 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Moderate | 2.6 Percentage of participants |
| SSA: Group 2: qIRV | SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Nausea: Mild | 1.7 Percentage of participants |
Primary
SSB: Percentage of Participants Reporting AEs Throughout the Sub Study
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included.
Time frame: SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination
Population: SSB: Safety population consisted of all enrolled participants who received the study intervention (0.5 mL or 1.0 mL).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants Reporting AEs Throughout the Sub Study | 22.8 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants Reporting AEs Throughout the Sub Study | 33.3 Percentage of participants |
Primary
SSB: Percentage of Participants Reporting SAEs Throughout the Sub Study
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
Time frame: SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination (Maximum up to 36 days)
Population: SSB: Safety population consisted of all enrolled participants who received the study intervention (0.5 mL or 1.0 mL).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants Reporting SAEs Throughout the Sub Study | 2.0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants Reporting SAEs Throughout the Sub Study | 0 Percentage of participants |
Primary
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Local reactions included pain, redness and swelling at the injection site, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: \> 5.0 cm to 10.0 cm; severe: \> 10 cm.
Time frame: SSB: From Day 1 to Day 7 after Vaccination
Population: SSB: E-diary safety population consisted of all enrolled participants who received the study intervention (0.5 mL or 1.0 mL) and with at least 1 day of e-diary data transferred.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 31.7 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Mild | 2.0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 4.0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 1.0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 5.9 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 42.6 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 43.1 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 32.4 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 2.9 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Mild | 2.0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 3.9 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 5.9 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 7.8 Percentage of participants |
Primary
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature \>=38.0 deg C and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C, severe: \>38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24h; moderate: \>2 times in 24h; severe: required IV hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.
Time frame: SSB: From Day 1 to Day 7 After Vaccination
Population: SSB: E-diary safety population consisted of all enrolled participants who received the study intervention (0.5 mL or 1.0 mL) and with at least 1 day of e-diary data transferred.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 27.7 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Nausea: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 36.6 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Mild | 9.9 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Moderate | 5.9 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Moderate | 4.0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Mild | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Mild | 15.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Moderate | 24.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Moderate | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 20.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Mild | 18.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Moderate | 27.7 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 18.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Severe | 2.0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Nausea: Mild | 5.0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Mild | 14.9 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Severe | 2.0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Moderate | 20.8 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Nausea: Moderate | 4.0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: Group 1: RSVpreF + qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Mild | 15.8 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Severe | 1.0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Mild | 10.8 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Moderate | 2.0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 28.4 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 26.5 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 5.9 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 26.5 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 15.7 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 2.0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Mild | 2.0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Moderate | 1.0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Nausea: Mild | 11.8 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Nausea: Moderate | 2.9 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Nausea: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Mild | 10.8 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Moderate | 2.9 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Severe | 0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Mild | 17.6 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Moderate | 13.7 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Severe | 1.0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Mild | 21.6 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Moderate | 22.5 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Severe | 1.0 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Mild | 11.8 Percentage of participants |
| SSA: Group 2: qIRV | SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Moderate | 16.7 Percentage of participants |
Secondary
SSB: GMT and GMR of NT for Each RSV A or RSV B 1 Month After Vaccination
GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of RSV A or RSV B neutralizing GMTs in the combination of 1 mL RSVpreF + qIRV (group 1) and 0.5 ml of RSVpreF + qIRV (group 2)
Time frame: SSB: At 1 Month after Vaccination (Day 1)
Population: Evaluable RSV immunogenicity population: all eligible participants who received the study intervention to which they were randomized, had the 1-month postvaccination blood collection within 27 to 42 days after vaccination, had at least 1 valid and determinate RSV NT result at the 1 month postvaccination blood collection, and had no major protocol violations from randomization through the 1 month postvaccination blood collection.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSB: GMT and GMR of NT for Each RSV A or RSV B 1 Month After Vaccination | NT: RSV A | 32044 Titer |
| SSA: Group 1: RSVpreF + qIRV | SSB: GMT and GMR of NT for Each RSV A or RSV B 1 Month After Vaccination | NT: RSV B | 30364 Titer |
| SSA: Group 2: qIRV | SSB: GMT and GMR of NT for Each RSV A or RSV B 1 Month After Vaccination | NT: RSV A | 30575 Titer |
| SSA: Group 2: qIRV | SSB: GMT and GMR of NT for Each RSV A or RSV B 1 Month After Vaccination | NT: RSV B | 28614 Titer |
Comparison: GMR for RSV A: RSVpreF + qIRV 1.0 mL (Group 1) combination to RSVpreF + qIRV 0.5 mL (Group 2)95% CI: [0.82, 1.339]
Comparison: GMR for RSV B: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)95% CI: [0.833, 1.352]
Secondary
SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination
GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of each strain neutralizing GMTs to the combination of 1 mL RSVpreF + qIRV (Group 1) and 0.5 ml of RSVpreF + qIRV (Group 2). The analysis was performed on the influenza strains: H1N1 A/Sydney, H3N2 A/Darwin, B/Austria, and B/Phuket.
Time frame: SSB: At 1 Month after Vaccination (Day 1)
Population: Evaluable HAI immunogenicity population: all eligible participants who received the study intervention to which they were randomized, and had the 1month postvaccination blood collection for HAI assay within 27-42 days after vaccination,had atleast 1 valid and determinate HAI result at 1 month postvaccination blood collection,had no major protocol violations from randomization through 1 month postvaccination blood collection. 'Number Analyzed'=participants evaluable for specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SSA: Group 1: RSVpreF + qIRV | SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination | HAI: H1N1 A/Sydney | 257 Titer |
| SSA: Group 1: RSVpreF + qIRV | SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination | HAI: H3N2 A/Darwin | 259 Titer |
| SSA: Group 1: RSVpreF + qIRV | SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination | HAI: B/Austria | 58 Titer |
| SSA: Group 1: RSVpreF + qIRV | SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination | HAI: B/Phuket | 32 Titer |
| SSA: Group 2: qIRV | SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination | HAI: B/Phuket | 29 Titer |
| SSA: Group 2: qIRV | SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination | HAI: H1N1 A/Sydney | 217 Titer |
| SSA: Group 2: qIRV | SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination | HAI: B/Austria | 54 Titer |
| SSA: Group 2: qIRV | SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination | HAI: H3N2 A/Darwin | 229 Titer |
Comparison: GMR for HAI: H1N1 A/Sydney: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)95% CI: [0.875, 1.614]
Comparison: GMR for HAI: H3N2 A/Darwin: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)95% CI: [0.867, 1.473]
Comparison: GMR for HAI: B/Austria: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)95% CI: [0.849, 1.383]
Comparison: GMR for HAI: B/Phuket: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)95% CI: [0.866, 1.392]