Healthy Participants
Conditions
Keywords
SARS-CoV-2, COVID-19, Flu, Influenza, Vaccine, RSV, Respiratory Syncytial Virus, Combination vaccine, mRNA vaccine
Brief summary
The purpose of the study is to learn about the safety and effects of a combined vaccine for RSV and COVID-19 when given with a seasonal flu vaccine or when given alone. A combined vaccine will help to reduce the number of vaccinations given when trying to prevent respiratory infections. This study is seeking participants who: * are 65 years of age or older. * are healthy or have well-controlled chronic conditions. * in the past have received at least 3 US-authorized mRNA COVID 19 vaccines, with the most recent vaccine being an updated booster vaccine given at least more than or equal to 150 days before Visit A101 (Day 1). * have not had a flu shot in the last 120 days. * agree to be present for all study visits, procedures, and blood draws. Participants will be involved in this study for 6 months. During this time, participants will have 2 study visits at the study clinic and a 6-month telephone contact.
Interventions
BIOLOGICALCombination [RSVpreF+BNTb162b2]
Combination of RSVpreF and Bivalent BNT162b2 given as a single intramuscular injection
Bivalent BNT162b2 given as an intramuscular injection
BIOLOGICALRSVpreF
RSVpreF given as an intramuscular injection
BIOLOGICALQIV
Licensed QIV given as an intramuscular injection
BIOLOGICALNormal Saline Placebo
Normal saline (0.9% sodium chloride solution for injection)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Substudy A Inclusion Criteria: 1. Male or female participants ≥65 years of age at Visit 1 (Day 1). 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 signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. 5. Participants who have received at least 3 prior US authorized mRNA COVID 19 vaccines, with the last dose being an updated (bivalent) vaccine given at least ≥150 days before Visit A101 (Day 1). Substudy A
Exclusion criteria
1. A confirmed diagnosis of COVID 19, 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. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 5. Allergy to egg proteins (egg or egg products) or chicken proteins. 6. Any 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 enrollment through conclusion of the study. 8. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study. 9. Receipt of any RSV vaccine at any time prior to enrollment, or planned receipt throughout the study. 10. Receipt of any influenza vaccine ≤120 days before study enrollment. 11. Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study. 12. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 2 Versus Group 3 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 2 to Group 3, was reported in the statistical analysis section. |
| Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | Within 6 Months after Vaccination | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention. 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 were included in this outcome measure. |
| Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) at 1 Month After Vaccination: Group 1 Versus Group 4 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 1 to Group 4, was reported in the statistical analysis section. |
| GMT and GMR of NTs for Respiratory Syncytial Virus Subgroup B (RSV B) at 1 Month After Vaccination: Group 1 Versus Group 4 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 1 to Group 4, was reported in the statistical analysis section. |
| GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 1 Versus Group 3 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 1 to Group 3, was reported in the statistical analysis section. |
| GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 1 Versus Group 3 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 1 to Group 3, was reported in the statistical analysis section. |
| GMT and GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H1N1 A/Victoria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H1N1 A/Victoria), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section. |
| GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H3N2 A/Darwin) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H3N2 A/Darwin), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section. |
| GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Austria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Austria), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section. |
| GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Phuket) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Phuket), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section. |
| GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 2 Versus Group 4 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 2 to Group 4, was reported in the statistical analysis section. |
| GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 2 Versus Group 4 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 2 to Group 4, was reported in the statistical analysis section. |
| GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 2 Versus Group 3 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 2 to Group 3, was reported in the statistical analysis section. |
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Day 1 to Day 7 after Vaccination on Day 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 and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm) and graded as mild: 2.5 cm to 5.0 cm; moderate: greater than (\>) 5.0 cm to 10.0 cm; severe: \> 10 cm. |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Day 1 to Day 7 after Vaccination on Day 1 | Systemic events included fever, fatigue, headache, vomiting, diarrhea, chills, new/worsened muscle pain and joint pain. These were recorded by participants in an e-diary. Fever was defined as oral temperature greater than or equal to (\>=) 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 and severe: \>38.9 to 40.0 deg C. Vomiting was categorized as mild: 1-2 times in 24 hours (h); moderate: \>2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea was categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h and severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity and severe: prevented daily routine activity. |
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | Within 1 Month after 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 were included in evaluation of this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 7 Versus Group 4 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 7 to Group 4, was reported in the statistical analysis section. |
| GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 7 Versus Group 3 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 7 to Group 3, was reported in the statistical analysis section. |
| GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 7 Versus Group 3 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 7 to Group 3, was reported in the statistical analysis section. |
| GMT and GMR of the Strain-Specific HAI Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H1N1 A/Victoria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H1N1 A/Victoria), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section. |
| GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H3N2 A/Darwin) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H3N2 A/Darwin), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section. |
| GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Austria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Austria), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section. |
| GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Phuket) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Phuket), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section. |
| GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 6 Versus Group 4 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 6 to Group 4, was reported in the statistical analysis section. |
| GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 6 Versus Group 4 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 6 to Group 4, was reported in the statistical analysis section. |
| GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 6 Versus Group 3 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 6 to Group 3, was reported in the statistical analysis section. |
| GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 6 Versus Group 3 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 6 to Group 3, was reported in the statistical analysis section. |
| GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 7 Versus Group 4 | 1 Month after Vaccination | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 7 to Group 4, was reported in the statistical analysis section. |
Countries
United States
Participant flow
Recruitment details
A total of 1142 participants were enrolled in this study, 1083 participants were randomized to receive study vaccination, out of which, 1073 participants were vaccinated.
Pre-assignment details
Participants were randomized to receive combined respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) and bivalent BNT162b2 (original/Omi BA.4/BA.5) vaccine \[RSVpreF + BNT162b2\], administered concomitantly with a seasonal quadrivalent influenza vaccine (QIV) or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV Participants were randomized to receive combination of RSVpreF and Bivalent BNT162b2 as a single intramuscular injection along with concomitant QIV as intramuscular injection on Day 1. | 155 |
| Group 2: [RSVpreF+BNT162b2] + Placebo Participants were randomized to receive combination of RSVpreF and Bivalent BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1. | 154 |
| Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1. | 152 |
| Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1. | 155 |
| Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1. | 151 |
| Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1. | 158 |
| Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1. | 158 |
| Total | 1,083 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 2 | 1 | 0 | 2 | 0 |
| Overall Study | No longer met eligibility criteria | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Other | 0 | 2 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 4 | 3 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Group 1: [RSVpreF + BNT162b2] + QIV | Group 2: [RSVpreF+BNT162b2] + Placebo | Group 3: BNT162b2 + Placebo | Group 4: RSVpreF + Placebo | Group 5: QIV + Placebo | Group 6: RSVpreF + BNT162b2 + Placebo | Group 7: RSVpreF + BNT162b2 + QIV |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 71.7 Years STANDARD_DEVIATION 4.94 | 71.7 Years STANDARD_DEVIATION 5.36 | 71.7 Years STANDARD_DEVIATION 5.01 | 71.1 Years STANDARD_DEVIATION 4.7 | 72.1 Years STANDARD_DEVIATION 4.69 | 72.3 Years STANDARD_DEVIATION 5.12 | 71.3 Years STANDARD_DEVIATION 4.87 | 71.6 Years STANDARD_DEVIATION 4.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 110 Participants | 21 Participants | 15 Participants | 11 Participants | 18 Participants | 12 Participants | 18 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 969 Participants | 134 Participants | 138 Participants | 140 Participants | 137 Participants | 139 Participants | 139 Participants | 142 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 8 Participants | 4 Participants | 2 Participants | 1 Participants | 3 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 81 Participants | 10 Participants | 12 Participants | 13 Participants | 10 Participants | 9 Participants | 14 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 963 Participants | 135 Participants | 138 Participants | 133 Participants | 143 Participants | 136 Participants | 140 Participants | 138 Participants |
| Sex: Female, Male Female | 603 Participants | 88 Participants | 94 Participants | 81 Participants | 81 Participants | 81 Participants | 95 Participants | 83 Participants |
| Sex: Female, Male Male | 480 Participants | 67 Participants | 60 Participants | 71 Participants | 74 Participants | 70 Participants | 63 Participants | 75 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 154 | 0 / 153 | 0 / 150 | 0 / 152 | 0 / 149 | 0 / 157 | 0 / 158 |
| other Total, other adverse events | 114 / 154 | 107 / 153 | 110 / 150 | 73 / 152 | 96 / 149 | 114 / 157 | 122 / 158 |
| serious Total, serious adverse events | 1 / 154 | 2 / 153 | 4 / 150 | 2 / 152 | 2 / 149 | 1 / 157 | 3 / 158 |
Outcome results
Primary
Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) at 1 Month After Vaccination: Group 1 Versus Group 4
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 1 to Group 4, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: Evaluable immunogenicity population (EIP)= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) at 1 Month After Vaccination: Group 1 Versus Group 4 | 18284 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) at 1 Month After Vaccination: Group 1 Versus Group 4 | 18498 Titer |
97.5% CI: [0.782, 1.249]
Primary
GMT and GMR of NTs for Respiratory Syncytial Virus Subgroup B (RSV B) at 1 Month After Vaccination: Group 1 Versus Group 4
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 1 to Group 4, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for Respiratory Syncytial Virus Subgroup B (RSV B) at 1 Month After Vaccination: Group 1 Versus Group 4 | 15014 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for Respiratory Syncytial Virus Subgroup B (RSV B) at 1 Month After Vaccination: Group 1 Versus Group 4 | 16677 Titer |
97.5% CI: [0.697, 1.162]
Primary
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 2 Versus Group 4
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 2 to Group 4, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 2 Versus Group 4 | 18414 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 2 Versus Group 4 | 18498 Titer |
97.5% CI: [0.769, 1.288]
Primary
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 2 Versus Group 4
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 2 to Group 4, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 2 Versus Group 4 | 18227 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 2 Versus Group 4 | 16677 Titer |
97.5% CI: [0.836, 1.429]
Primary
GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 1 Versus Group 3
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 1 to Group 3, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 1 Versus Group 3 | 3083 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 1 Versus Group 3 | 3667 Titer |
97.5% CI: [0.605, 1.168]
Primary
GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 2 Versus Group 3
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 2 to Group 3, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 2 Versus Group 3 | 3083 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 2 Versus Group 3 | 3667 Titer |
97.5% CI: [0.594, 1.19]
Primary
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 1 Versus Group 3
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 1 to Group 3, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 1 Versus Group 3 | 9849 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 1 Versus Group 3 | 12439 Titer |
97.5% CI: [0.618, 1.014]
Primary
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 2 Versus Group 3
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 2 to Group 3, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 2 Versus Group 3 | 10489 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 2 Versus Group 3 | 12439 Titer |
97.5% CI: [0.632, 1.125]
Primary
GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Austria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Austria), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5 | 71 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5 | 68 Titer |
97.5% CI: [0.773, 1.434]
Primary
GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Phuket) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Phuket), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5 | 30 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5 | 27 Titer |
97.5% CI: [0.807, 1.515]
Primary
GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H3N2 A/Darwin) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H3N2 A/Darwin), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5 | 138 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5 | 122 Titer |
97.5% CI: [0.909, 1.402]
Primary
GMT and GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H1N1 A/Victoria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H1N1 A/Victoria), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5 | 70 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5 | 67 Titer |
97.5% CI: [0.785, 1.423]
Primary
Percentage of Participants With Adverse Events (AEs) Within 1 Month After 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 were included in evaluation of this outcome measure.
Time frame: Within 1 Month after Vaccination
Population: Safety population included all participants who received the study intervention. Here, Number of Participants Analyzed signifies number of participants reporting at least 1 response in the e-diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 9.1 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 8.5 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 8.0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 7.2 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 8.1 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 8.9 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 8.9 Percentage of participants |
Primary
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 electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm) and 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: Day 1 to Day 7 after Vaccination on Day 1
Population: Safety population included all participants who received the study intervention. Here, Number of Participants Analyzed signifies number of participants reporting at least 1 response in the e-diary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Mild | 3.2 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 3.2 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 0 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 4.5 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 1.9 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 7.8 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 49.4 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 3.3 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 5.9 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 4.6 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 0.7 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 45.8 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 6.5 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Mild | 5.9 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 5.3 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 2.0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 54.7 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 7.3 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 4.0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Mild | 5.3 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 0.7 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 10.5 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Mild | 1.3 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 1.3 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 2.0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 1.3 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 2.0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Mild | 2.0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 48.3 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 2.0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 4.0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 3.4 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 11.5 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Mild | 6.4 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 4.5 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 45.2 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 7.6 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 0 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 5.1 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0.6 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Severe | 1.3 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Moderate | 7.6 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0.6 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Severe | 1.3 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 2.5 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Mild | 5.1 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 4.4 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at the injection site: Mild | 44.9 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 3.2 Percentage of participants |
Primary
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention. 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 were included in this outcome measure.
Time frame: Within 6 Months after Vaccination
Population: Safety population included all participants who received the study intervention. Here, Number of Participants Analyzed signifies number of participants reporting at least 1 response in the e-diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 0.6 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 1.3 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 2.7 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 1.3 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 1.3 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 0.6 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | 1.9 Percentage of participants |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Systemic events included fever, fatigue, headache, vomiting, diarrhea, chills, new/worsened muscle pain and joint pain. These were recorded by participants in an e-diary. Fever was defined as oral temperature greater than or equal to (\>=) 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 and severe: \>38.9 to 40.0 deg C. Vomiting was categorized as mild: 1-2 times in 24 hours (h); moderate: \>2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea was categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h and severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity and severe: prevented daily routine activity.
Time frame: Day 1 to Day 7 after Vaccination on Day 1
Population: Safety population included all participants who received the study intervention. Here, Number of Participants Analyzed signifies number of participants reporting at least 1 response in the e-diary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Mild | 1.3 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Mild | 7.8 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 19.5 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Severe | 0 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Severe | 0 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Moderate | 0.6 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Moderate | 0.6 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 21.4 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 1.3 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 0 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Mild | 5.8 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Severe | 0 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Severe | 0 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Moderate | 5.2 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 16.2 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Severe | 0 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Mild | 3.2 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Mild | 7.1 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Severe | 0 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Moderate | 3.9 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Moderate | 5.2 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 5.2 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Mild | 4.5 Percentage of participants |
| Group 1: [RSVpreF + BNT162b2] + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Moderate | 3.2 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Moderate | 4.6 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Severe | 0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Moderate | 2.0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Severe | 0.7 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Mild | 4.6 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Moderate | 0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Moderate | 0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Severe | 0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 17.0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 1.3 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Mild | 5.9 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Severe | 0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 19.0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Mild | 0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Mild | 3.3 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Mild | 2.0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Moderate | 1.3 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Severe | 0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Moderate | 2.6 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 19.0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Severe | 0 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Mild | 5.9 Percentage of participants |
| Group 2: [RSVpreF+BNT162b2] + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 5.9 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Severe | 0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Mild | 6.7 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Severe | 0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Moderate | 2.7 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 18.0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Severe | 0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 0.7 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Moderate | 7.3 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 14.0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Moderate | 0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Mild | 1.3 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 8.7 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Mild | 1.3 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Mild | 1.3 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Severe | 0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Moderate | 0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Severe | 0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Severe | 0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Moderate | 4.7 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Mild | 4.0 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Moderate | 1.3 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 16.7 Percentage of participants |
| Group 3: BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Mild | 6.0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Moderate | 5.9 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Mild | 2.0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 3.3 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Mild | 2.0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Severe | 0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Severe | 0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Mild | 3.9 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 15.8 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 0.7 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Moderate | 3.9 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Severe | 0.7 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Mild | 7.2 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 7.9 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 15.8 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Severe | 0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Severe | 0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Moderate | 2.0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Mild | 0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Mild | 2.6 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Severe | 0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Moderate | 0 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Moderate | 2.6 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Moderate | 1.3 Percentage of participants |
| Group 4: RSVpreF + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Mild | 0.7 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Mild | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Moderate | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Severe | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 17.4 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 10.7 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 0.7 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 10.1 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 2.7 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Mild | 0.7 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Moderate | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Severe | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Mild | 7.4 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Moderate | 2.0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Severe | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Mild | 2.0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Moderate | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Severe | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Mild | 6.0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Moderate | 4.7 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Severe | 0 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Moderate | 3.4 Percentage of participants |
| Group 5: QIV + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Severe | 0 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Severe | 0 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Severe | 0 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Moderate | 0 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Mild | 8.3 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Severe | 0 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Moderate | 5.1 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Mild | 4.5 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Moderate | 0 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Mild | 0.6 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Moderate | 0.6 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Severe | 0.6 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 0.6 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 8.3 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Mild | 4.5 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 15.3 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 1.3 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Moderate | 5.7 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 20.4 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 17.2 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Mild | 1.3 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Severe | 0 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Moderate | 5.1 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Mild | 4.5 Percentage of participants |
| Group 6: RSVpreF + BNT162b2 + Placebo | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Severe | 0.6 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 7.0 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Severe | 0.6 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Mild | 5.7 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Moderate | 1.9 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 11.4 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Severe | 0 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 20.9 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Mild | 7.0 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Mild | 10.1 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Severe | 0 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Mild | 5.1 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Moderate | 0 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Severe | 0 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Chills: Moderate | 5.1 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Moderate | 7.6 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 1.9 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Moderate | 1.9 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Mild | 1.3 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 24.1 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Mild | 2.5 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Severe | 0.6 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened muscle pain: Severe | 0 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 0.6 Percentage of participants |
| Group 7: RSVpreF + BNT162b2 + QIV | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | New or worsened joint pain: Moderate | 3.8 Percentage of participants |
Secondary
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 6 Versus Group 4
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 6 to Group 4, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 6 Versus Group 4 | 26452 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 6 Versus Group 4 | 18498 Titer |
97.5% CI: [1.131, 1.808]
Secondary
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 7 Versus Group 4
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 7 to Group 4, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 7 Versus Group 4 | 26303 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 7 Versus Group 4 | 18498 Titer |
97.5% CI: [1.123, 1.801]
Secondary
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 6 Versus Group 4
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 6 to Group 4, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 6 Versus Group 4 | 22859 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 6 Versus Group 4 | 16677 Titer |
97.5% CI: [1.06, 1.773]
Secondary
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 7 Versus Group 4
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 7 to Group 4, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 7 Versus Group 4 | 21182 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 7 Versus Group 4 | 16677 Titer |
97.5% CI: [0.977, 1.651]
Secondary
GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 6 Versus Group 3
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 6 to Group 3, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 6 Versus Group 3 | 3430 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 6 Versus Group 3 | 3667 Titer |
97.5% CI: [0.673, 1.3]
Secondary
GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 7 Versus Group 3
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 7 to Group 3, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 7 Versus Group 3 | 3148 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 7 Versus Group 3 | 3667 Titer |
97.5% CI: [0.61, 1.208]
Secondary
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 6 Versus Group 3
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 6 to Group 3, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 6 Versus Group 3 | 12111 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 6 Versus Group 3 | 12439 Titer |
97.5% CI: [0.74, 1.281]
Secondary
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 7 Versus Group 3
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 7 to Group 3, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 7 Versus Group 3 | 12588 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 7 Versus Group 3 | 12439 Titer |
97.5% CI: [0.764, 1.34]
Secondary
GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Austria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Austria), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5 | 107 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5 | 68 Titer |
97.5% CI: [1.155, 2.165]
Secondary
GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Phuket) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Phuket), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5 | 93 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5 | 27 Titer |
97.5% CI: [2.64, 4.604]
Secondary
GMT and GMR of the Strain-Specific HAI Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H1N1 A/Victoria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H1N1 A/Victoria), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of the Strain-Specific HAI Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5 | 166 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of the Strain-Specific HAI Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5 | 67 Titer |
97.5% CI: [1.914, 3.232]
Secondary
GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H3N2 A/Darwin) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H3N2 A/Darwin), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section.
Time frame: 1 Month after Vaccination
Population: EIP= randomized participants who were eligible; received study intervention(s) to which they were randomized; 1-month post-vaccination blood collected within 27-42 days post vaccination; no protocol violations from randomization till 1-month postvaccination blood draw; had at least 1 valid, determinate assay result 1 month post vaccination. Number of Participants Analyzed = participants with valid and determinate assay results in EIP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: [RSVpreF + BNT162b2] + QIV | GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5 | 159 Titer |
| Group 2: [RSVpreF+BNT162b2] + Placebo | GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5 | 122 Titer |
97.5% CI: [1.049, 1.612]