| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 to Day 7 after Vaccination on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Group 3: BNT162b2 + Placebo | Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1. | | OG003 | Group 4: RSVpreF + Placebo | Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1. | | OG004 | Group 5: QIV + Placebo | Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1. | | OG005 | Group 6: RSVpreF + BNT162b2 + Placebo | Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1. | | OG006 | Group 7: RSVpreF + BNT162b2 + QIV | Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1. |
| | Units | Counts |
|---|
| Participants | - OG000154
- OG001153
- OG002150
- OG003
|
| | Title | Denominators | Categories |
|---|
| Pain at the injection site: Mild | | | Title | Measurements |
|---|
| - OG00049.4(41.2 to 57.5)
- OG00145.8(37.7 to 54.0)
- OG00254.7(46.3 to 62.8)
|
|
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 to Day 7 after Vaccination on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Group 2: [RSVpreF+BNT162b2] + Placebo |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Group 3: BNT162b2 + Placebo | Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 6 Months after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Group 4: RSVpreF + Placebo | Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
|
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Group 4: RSVpreF + Placebo | Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
|
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Group 3: BNT162b2 + Placebo | Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
|
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Group 3: BNT162b2 + Placebo | Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
|
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Group 5: QIV + Placebo | Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
|
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Group 5: QIV + Placebo | Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
|
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Group 5: QIV + Placebo | Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
|
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Group 5: QIV + Placebo | Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
|
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Group 4: RSVpreF + Placebo | Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
| |
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Group 4: RSVpreF + Placebo | Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
| |
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Group 3: BNT162b2 + Placebo | Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
|
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Group 3: BNT162b2 + Placebo | Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
| |
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | Group 7: RSVpreF + BNT162b2 + QIV | Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1. | | OG001 | Group 4: RSVpreF + Placebo | Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
| |
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | Group 7: RSVpreF + BNT162b2 + QIV | Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1. | | OG001 | Group 4: RSVpreF + Placebo | Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
| |
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | Group 7: RSVpreF + BNT162b2 + QIV | Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1. | | OG001 | Group 3: BNT162b2 + Placebo | Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
|
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | Group 7: RSVpreF + BNT162b2 + QIV | Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1. | | OG001 | Group 3: BNT162b2 + Placebo | Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
|
| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
|---|
| OG000 | Group 7: RSVpreF + BNT162b2 + QIV | Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1. | | OG001 | Group 5: QIV + Placebo | Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
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| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
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| OG000 | Group 7: RSVpreF + BNT162b2 + QIV | Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1. | | OG001 | Group 5: QIV + Placebo | Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
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| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
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| OG000 | Group 7: RSVpreF + BNT162b2 + QIV | Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1. | | OG001 | Group 5: QIV + Placebo | Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
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| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
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| OG000 | Group 7: RSVpreF + BNT162b2 + QIV | Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1. | | OG001 | Group 5: QIV + Placebo | Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
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| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
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| OG000 | Group 6: RSVpreF + BNT162b2 + Placebo | Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1. | | OG001 | Group 4: RSVpreF + Placebo | Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
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| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
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| OG000 | Group 6: RSVpreF + BNT162b2 + Placebo | Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1. | | OG001 | Group 4: RSVpreF + Placebo | Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
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| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
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| OG000 | Group 6: RSVpreF + BNT162b2 + Placebo | Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1. | | OG001 | Group 3: BNT162b2 + Placebo | Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
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| 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. | 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. | Posted | | Geometric Mean | 97.5% Confidence Interval | Titer | | 1 Month after Vaccination | | | | ID | Title | Description |
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| OG000 | Group 6: RSVpreF + BNT162b2 + Placebo | Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1. | | OG001 | Group 3: BNT162b2 + Placebo | Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1. |
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