Trial Outcomes & Findings for A Study to Learn About Two or More Vaccines That Are Put Together as One Shot Against Infectious Lung Illnesses, Including COVID-19 and Respiratory Syncytial Virus (RSV). (NCT NCT05886777)

NCT ID: NCT05886777

Last Updated: 2024-12-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 1142 participants
• Primary outcome timeframe: Day 1 to Day 7 after Vaccination on Day 1
• Results posted on: 2024-12-18

Participant Flow

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.

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.

Participant milestones

Measure	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.	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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
Overall Study STARTED	155	154	152	155	151	158	158
Overall Study COMPLETED	153	151	147	150	148	155	157
Overall Study NOT COMPLETED	2	3	5	5	3	3	1

Reasons for withdrawal

Measure	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.	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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
Overall Study Lost to Follow-up	1	0	2	1	0	2	0
Overall Study Other	0	2	1	0	0	0	0
Overall Study Withdrawal by Subject	1	0	1	4	3	1	1
Overall Study Protocol Violation	0	0	1	0	0	0	0
Overall Study No longer met eligibility criteria	0	1	0	0	0	0	0

Baseline Characteristics

A Study to Learn About Two or More Vaccines That Are Put Together as One Shot Against Infectious Lung Illnesses, Including COVID-19 and Respiratory Syncytial Virus (RSV).

Baseline characteristics by cohort

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=155 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=154 Participants 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.	Group 3: BNT162b2 + Placebo n=152 Participants Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo n=155 Participants Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo n=151 Participants Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo n=158 Participants Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV n=158 Participants Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.	Total n=1083 Participants Total of all reporting groups
Age, Continuous	71.7 Years STANDARD_DEVIATION 5.36 • n=5 Participants	71.7 Years STANDARD_DEVIATION 5.01 • n=7 Participants	71.1 Years STANDARD_DEVIATION 4.70 • n=5 Participants	72.1 Years STANDARD_DEVIATION 4.69 • n=4 Participants	72.3 Years STANDARD_DEVIATION 5.12 • n=21 Participants	71.3 Years STANDARD_DEVIATION 4.87 • n=8 Participants	71.6 Years STANDARD_DEVIATION 4.79 • n=8 Participants	71.7 Years STANDARD_DEVIATION 4.94 • n=24 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	94 Participants n=7 Participants	81 Participants n=5 Participants	81 Participants n=4 Participants	81 Participants n=21 Participants	95 Participants n=8 Participants	83 Participants n=8 Participants	603 Participants n=24 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	60 Participants n=7 Participants	71 Participants n=5 Participants	74 Participants n=4 Participants	70 Participants n=21 Participants	63 Participants n=8 Participants	75 Participants n=8 Participants	480 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	15 Participants n=7 Participants	11 Participants n=5 Participants	18 Participants n=4 Participants	12 Participants n=21 Participants	18 Participants n=8 Participants	15 Participants n=8 Participants	110 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	134 Participants n=5 Participants	138 Participants n=7 Participants	140 Participants n=5 Participants	137 Participants n=4 Participants	139 Participants n=21 Participants	139 Participants n=8 Participants	142 Participants n=8 Participants	969 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	4 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	4 Participants n=24 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	5 Participants n=8 Participants	26 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	10 Participants n=4 Participants	9 Participants n=21 Participants	14 Participants n=8 Participants	13 Participants n=8 Participants	81 Participants n=24 Participants
Race (NIH/OMB) White	135 Participants n=5 Participants	138 Participants n=7 Participants	133 Participants n=5 Participants	143 Participants n=4 Participants	136 Participants n=21 Participants	140 Participants n=8 Participants	138 Participants n=8 Participants	963 Participants n=24 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	5 Participants n=24 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=154 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=153 Participants 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.	Group 3: BNT162b2 + Placebo n=150 Participants Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo n=152 Participants Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo n=149 Participants Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo n=157 Participants Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV n=158 Participants Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
Percentage of Participants With Local Reactions Within 7 Days After Vaccination Pain at the injection site: Mild	49.4 Percentage of participants Interval 41.2 to 57.5	45.8 Percentage of participants Interval 37.7 to 54.0	54.7 Percentage of participants Interval 46.3 to 62.8	10.5 Percentage of participants Interval 6.1 to 16.5	48.3 Percentage of participants Interval 40.1 to 56.6	45.2 Percentage of participants Interval 37.3 to 53.4	44.9 Percentage of participants Interval 37.0 to 53.0
Percentage of Participants With Local Reactions Within 7 Days After Vaccination Pain at the injection site: Moderate	7.8 Percentage of participants Interval 4.1 to 13.2	5.9 Percentage of participants Interval 2.7 to 10.9	7.3 Percentage of participants Interval 3.7 to 12.7	0 Percentage of participants Interval 0.0 to 2.4	3.4 Percentage of participants Interval 1.1 to 7.7	11.5 Percentage of participants Interval 6.9 to 17.5	7.6 Percentage of participants Interval 4.0 to 12.9
Percentage of Participants With Local Reactions Within 7 Days After Vaccination Pain at the injection site: Severe	0 Percentage of participants Interval 0.0 to 2.4	0.7 Percentage of participants Interval 0.0 to 3.6	0.7 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.3	1.3 Percentage of participants Interval 0.2 to 4.5
Percentage of Participants With Local Reactions Within 7 Days After Vaccination Redness: Mild	3.2 Percentage of participants Interval 1.1 to 7.4	5.9 Percentage of participants Interval 2.7 to 10.9	5.3 Percentage of participants Interval 2.3 to 10.2	1.3 Percentage of participants Interval 0.2 to 4.7	2.0 Percentage of participants Interval 0.4 to 5.8	6.4 Percentage of participants Interval 3.1 to 11.4	5.1 Percentage of participants Interval 2.2 to 9.7
Percentage of Participants With Local Reactions Within 7 Days After Vaccination Redness: Moderate	4.5 Percentage of participants Interval 1.8 to 9.1	3.3 Percentage of participants Interval 1.1 to 7.5	2.0 Percentage of participants Interval 0.4 to 5.7	1.3 Percentage of participants Interval 0.2 to 4.7	2.0 Percentage of participants Interval 0.4 to 5.8	5.1 Percentage of participants Interval 2.2 to 9.8	3.2 Percentage of participants Interval 1.0 to 7.2
Percentage of Participants With Local Reactions Within 7 Days After Vaccination Redness: Severe	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	1.3 Percentage of participants Interval 0.2 to 4.5	0.6 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants With Local Reactions Within 7 Days After Vaccination Swelling: Mild	3.2 Percentage of participants Interval 1.1 to 7.4	6.5 Percentage of participants Interval 3.2 to 11.7	5.3 Percentage of participants Interval 2.3 to 10.2	2.0 Percentage of participants Interval 0.4 to 5.7	4.0 Percentage of participants Interval 1.5 to 8.6	7.6 Percentage of participants Interval 4.0 to 13.0	2.5 Percentage of participants Interval 0.7 to 6.4
Percentage of Participants With Local Reactions Within 7 Days After Vaccination Swelling: Moderate	1.9 Percentage of participants Interval 0.4 to 5.6	4.6 Percentage of participants Interval 1.9 to 9.2	4.0 Percentage of participants Interval 1.5 to 8.5	1.3 Percentage of participants Interval 0.2 to 4.7	2.0 Percentage of participants Interval 0.4 to 5.8	4.5 Percentage of participants Interval 1.8 to 9.0	4.4 Percentage of participants Interval 1.8 to 8.9
Percentage of Participants With Local Reactions Within 7 Days After Vaccination Swelling: Severe	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0.6 Percentage of participants Interval 0.0 to 3.5	0 Percentage of participants Interval 0.0 to 2.3

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=154 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=153 Participants 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.	Group 3: BNT162b2 + Placebo n=150 Participants Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo n=152 Participants Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo n=149 Participants Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo n=157 Participants Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV n=158 Participants Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Fever: Mild	3.2 Percentage of participants Interval 1.1 to 7.4	2.0 Percentage of participants Interval 0.4 to 5.6	1.3 Percentage of participants Interval 0.2 to 4.7	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	1.3 Percentage of participants Interval 0.2 to 4.5	2.5 Percentage of participants Interval 0.7 to 6.4
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Fever: Moderate	0.6 Percentage of participants Interval 0.0 to 3.6	1.3 Percentage of participants Interval 0.2 to 4.6	0 Percentage of participants Interval 0.0 to 2.4	1.3 Percentage of participants Interval 0.2 to 4.7	0 Percentage of participants Interval 0.0 to 2.4	0.6 Percentage of participants Interval 0.0 to 3.5	1.9 Percentage of participants Interval 0.4 to 5.4
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Fever: Severe	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.3	0 Percentage of participants Interval 0.0 to 2.3
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Fatigue: Mild	21.4 Percentage of participants Interval 15.2 to 28.8	17.0 Percentage of participants Interval 11.4 to 23.9	18.0 Percentage of participants Interval 12.2 to 25.1	15.8 Percentage of participants Interval 10.4 to 22.6	17.4 Percentage of participants Interval 11.7 to 24.5	17.2 Percentage of participants Interval 11.6 to 24.0	20.9 Percentage of participants Interval 14.8 to 28.1
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Fatigue: Moderate	19.5 Percentage of participants Interval 13.5 to 26.6	19.0 Percentage of participants Interval 13.1 to 26.1	16.7 Percentage of participants Interval 11.1 to 23.6	7.9 Percentage of participants Interval 4.1 to 13.4	10.7 Percentage of participants Interval 6.3 to 16.9	20.4 Percentage of participants Interval 14.4 to 27.5	24.1 Percentage of participants Interval 17.6 to 31.5
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Fatigue: Severe	1.3 Percentage of participants Interval 0.2 to 4.6	1.3 Percentage of participants Interval 0.2 to 4.6	0.7 Percentage of participants Interval 0.0 to 3.7	0.7 Percentage of participants Interval 0.0 to 3.6	0.7 Percentage of participants Interval 0.0 to 3.7	1.3 Percentage of participants Interval 0.2 to 4.5	1.9 Percentage of participants Interval 0.4 to 5.4
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Headache: Mild	16.2 Percentage of participants Interval 10.8 to 23.0	19.0 Percentage of participants Interval 13.1 to 26.1	14.0 Percentage of participants Interval 8.9 to 20.6	15.8 Percentage of participants Interval 10.4 to 22.6	10.1 Percentage of participants Interval 5.7 to 16.1	15.3 Percentage of participants Interval 10.0 to 21.9	11.4 Percentage of participants Interval 6.9 to 17.4
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Headache: Moderate	5.2 Percentage of participants Interval 2.3 to 10.0	5.9 Percentage of participants Interval 2.7 to 10.9	8.7 Percentage of participants Interval 4.7 to 14.4	3.3 Percentage of participants Interval 1.1 to 7.5	2.7 Percentage of participants Interval 0.7 to 6.7	8.3 Percentage of participants Interval 4.5 to 13.7	7.0 Percentage of participants Interval 3.5 to 12.1
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Headache: Severe	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0.6 Percentage of participants Interval 0.0 to 3.5	0.6 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Vomiting: Mild	1.3 Percentage of participants Interval 0.2 to 4.6	0 Percentage of participants Interval 0.0 to 2.4	1.3 Percentage of participants Interval 0.2 to 4.7	2.6 Percentage of participants Interval 0.7 to 6.6	0.7 Percentage of participants Interval 0.0 to 3.7	0.6 Percentage of participants Interval 0.0 to 3.5	1.3 Percentage of participants Interval 0.2 to 4.5
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Vomiting: Moderate	0.6 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.3	0 Percentage of participants Interval 0.0 to 2.3
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Vomiting: Severe	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.3	0 Percentage of participants Interval 0.0 to 2.3
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Diarrhea: Mild	5.8 Percentage of participants Interval 2.7 to 10.8	3.3 Percentage of participants Interval 1.1 to 7.5	4.0 Percentage of participants Interval 1.5 to 8.5	7.2 Percentage of participants Interval 3.7 to 12.6	7.4 Percentage of participants Interval 3.7 to 12.8	4.5 Percentage of participants Interval 1.8 to 9.0	10.1 Percentage of participants Interval 5.9 to 15.9
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Diarrhea: Moderate	5.2 Percentage of participants Interval 2.3 to 10.0	0 Percentage of participants Interval 0.0 to 2.4	1.3 Percentage of participants Interval 0.2 to 4.7	2.6 Percentage of participants Interval 0.7 to 6.6	2.0 Percentage of participants Interval 0.4 to 5.8	0 Percentage of participants Interval 0.0 to 2.3	1.9 Percentage of participants Interval 0.4 to 5.4
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Diarrhea: Severe	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0.7 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.3	0.6 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Chills: Mild	7.1 Percentage of participants Interval 3.6 to 12.4	5.9 Percentage of participants Interval 2.7 to 10.9	6.7 Percentage of participants Interval 3.2 to 11.9	2.0 Percentage of participants Interval 0.4 to 5.7	2.0 Percentage of participants Interval 0.4 to 5.8	4.5 Percentage of participants Interval 1.8 to 9.0	5.7 Percentage of participants Interval 2.6 to 10.5
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Chills: Moderate	3.2 Percentage of participants Interval 1.1 to 7.4	2.0 Percentage of participants Interval 0.4 to 5.6	2.7 Percentage of participants Interval 0.7 to 6.7	2.0 Percentage of participants Interval 0.4 to 5.7	0 Percentage of participants Interval 0.0 to 2.4	5.1 Percentage of participants Interval 2.2 to 9.8	5.1 Percentage of participants Interval 2.2 to 9.7
Percentage of Participants With Systemic Events Within 7 Days After Vaccination Chills: Severe	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0.6 Percentage of participants Interval 0.0 to 3.5	0 Percentage of participants Interval 0.0 to 2.3
Percentage of Participants With Systemic Events Within 7 Days After Vaccination New or worsened muscle pain: Mild	7.8 Percentage of participants Interval 4.1 to 13.2	5.9 Percentage of participants Interval 2.7 to 10.9	6.0 Percentage of participants Interval 2.8 to 11.1	3.9 Percentage of participants Interval 1.5 to 8.4	6.0 Percentage of participants Interval 2.8 to 11.2	8.3 Percentage of participants Interval 4.5 to 13.7	7.0 Percentage of participants Interval 3.5 to 12.1
Percentage of Participants With Systemic Events Within 7 Days After Vaccination New or worsened muscle pain: Moderate	5.2 Percentage of participants Interval 2.3 to 10.0	4.6 Percentage of participants Interval 1.9 to 9.2	4.7 Percentage of participants Interval 1.9 to 9.4	5.9 Percentage of participants Interval 2.7 to 10.9	4.7 Percentage of participants Interval 1.9 to 9.4	5.1 Percentage of participants Interval 2.2 to 9.8	7.6 Percentage of participants Interval 4.0 to 12.9
Percentage of Participants With Systemic Events Within 7 Days After Vaccination New or worsened muscle pain: Severe	0 Percentage of participants Interval 0.0 to 2.4	0.7 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0.6 Percentage of participants Interval 0.0 to 3.5	0 Percentage of participants Interval 0.0 to 2.3
Percentage of Participants With Systemic Events Within 7 Days After Vaccination New or worsened joint pain: Mild	4.5 Percentage of participants Interval 1.8 to 9.1	4.6 Percentage of participants Interval 1.9 to 9.2	1.3 Percentage of participants Interval 0.2 to 4.7	2.0 Percentage of participants Interval 0.4 to 5.7	0.7 Percentage of participants Interval 0.0 to 3.7	4.5 Percentage of participants Interval 1.8 to 9.0	5.1 Percentage of participants Interval 2.2 to 9.7
Percentage of Participants With Systemic Events Within 7 Days After Vaccination New or worsened joint pain: Moderate	3.9 Percentage of participants Interval 1.4 to 8.3	2.6 Percentage of participants Interval 0.7 to 6.6	7.3 Percentage of participants Interval 3.7 to 12.7	3.9 Percentage of participants Interval 1.5 to 8.4	3.4 Percentage of participants Interval 1.1 to 7.7	5.7 Percentage of participants Interval 2.7 to 10.6	3.8 Percentage of participants Interval 1.4 to 8.1
Percentage of Participants With Systemic Events Within 7 Days After Vaccination New or worsened joint pain: Severe	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.3	0.6 Percentage of participants Interval 0.0 to 3.5

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=154 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=153 Participants 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.	Group 3: BNT162b2 + Placebo n=150 Participants Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo n=152 Participants Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo n=149 Participants Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo n=157 Participants Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV n=158 Participants Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination	9.1 Percentage of participants Interval 5.1 to 14.8	8.5 Percentage of participants Interval 4.6 to 14.1	8.0 Percentage of participants Interval 4.2 to 13.6	7.2 Percentage of participants Interval 3.7 to 12.6	8.1 Percentage of participants Interval 4.2 to 13.6	8.9 Percentage of participants Interval 5.0 to 14.5	8.9 Percentage of participants Interval 4.9 to 14.4

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=154 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=153 Participants 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.	Group 3: BNT162b2 + Placebo n=150 Participants Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo n=152 Participants Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo n=149 Participants Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo n=157 Participants Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV n=158 Participants Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination	0.6 Percentage of participants Interval 0.0 to 3.6	1.3 Percentage of participants Interval 0.2 to 4.6	2.7 Percentage of participants Interval 0.7 to 6.7	1.3 Percentage of participants Interval 0.2 to 4.7	1.3 Percentage of participants Interval 0.2 to 4.8	0.6 Percentage of participants Interval 0.0 to 3.5	1.9 Percentage of participants Interval 0.4 to 5.4

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=151 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=147 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
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 Interval 15576.6 to 21462.6	18498 Titer Interval 15570.0 to 21975.9	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=151 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=147 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
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 Interval 12543.8 to 17971.8	16677 Titer Interval 13884.0 to 20031.4	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=151 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=145 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
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 Interval 2476.7 to 3838.1	3667 Titer Interval 2861.9 to 4697.5	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=151 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=145 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 1 Versus Group 3	9849 Titer Interval 8497.6 to 11416.5	12439 Titer Interval 10185.9 to 15190.1	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=149 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=143 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
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 Interval 56.8 to 87.3	67 Titer Interval 54.1 to 82.0	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=149 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=144 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
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 Interval 117.3 to 162.3	122 Titer Interval 105.7 to 141.4	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=149 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=143 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
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 Interval 57.5 to 88.8	68 Titer Interval 54.3 to 84.8	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=148 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=141 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
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 Interval 23.6 to 37.2	27 Titer Interval 21.5 to 33.3	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=148 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=147 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 2 Versus Group 4	18414 Titer Interval 15172.8 to 22346.9	18498 Titer Interval 15570.0 to 21975.9	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=148 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=147 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 2 Versus Group 4	18227 Titer Interval 14961.9 to 22204.2	16677 Titer Interval 13884.0 to 20031.4	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=147 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=145 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
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 Interval 2412.5 to 3940.4	3667 Titer Interval 2861.9 to 4697.5	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=148 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=145 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 2 Versus Group 3	10489 Titer Interval 8500.2 to 12943.5	12439 Titer Interval 10185.9 to 15190.1	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=154 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=147 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 7 Versus Group 4	26303 Titer Interval 22338.8 to 30970.5	18498 Titer Interval 15570.0 to 21975.9	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=154 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=147 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 7 Versus Group 4	21182 Titer Interval 17525.4 to 25600.8	16677 Titer Interval 13884.0 to 20031.4	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=153 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=145 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
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 Interval 2482.6 to 3992.0	3667 Titer Interval 2861.9 to 4697.5	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=153 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=145 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 7 Versus Group 3	12588 Titer Interval 10312.2 to 15365.4	12439 Titer Interval 10185.9 to 15190.1	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=152 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=143 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
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 Interval 141.0 to 194.7	67 Titer Interval 54.1 to 82.0	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=151 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=144 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
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 Interval 135.6 to 186.5	122 Titer Interval 105.7 to 141.4	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=150 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=143 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
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 Interval 85.8 to 134.4	68 Titer Interval 54.3 to 84.8	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=149 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=141 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
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 Interval 78.5 to 111.0	27 Titer Interval 21.5 to 33.3	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=149 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=147 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 6 Versus Group 4	26452 Titer Interval 22515.2 to 31076.8	18498 Titer Interval 15570.0 to 21975.9	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=148 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=147 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 6 Versus Group 4	22859 Titer Interval 19040.4 to 27442.5	16677 Titer Interval 13884.0 to 20031.4	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=148 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=145 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
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 Interval 2756.9 to 4267.7	3667 Titer Interval 2861.9 to 4697.5	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=148 Participants 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=145 Participants 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.	Group 3: BNT162b2 + Placebo Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 6 Versus Group 3	12111 Titer Interval 10010.3 to 14652.1	12439 Titer Interval 10185.9 to 15190.1	—	—	—	—	—

Adverse Events

Group 1: [RSVpreF + BNT162b2] + QIV

Serious events: 1 serious events

Other events: 114 other events

Deaths: 0 deaths

Group 2: [RSVpreF+BNT162b2] + Placebo

Serious events: 2 serious events

Other events: 107 other events

Deaths: 0 deaths

Group 3: BNT162b2 + Placebo

Serious events: 4 serious events

Other events: 110 other events

Deaths: 0 deaths

Group 4: RSVpreF + Placebo

Serious events: 2 serious events

Other events: 73 other events

Deaths: 0 deaths

Group 5: QIV + Placebo

Serious events: 2 serious events

Other events: 96 other events

Deaths: 0 deaths

Group 6: RSVpreF + BNT162b2 + Placebo

Serious events: 1 serious events

Other events: 114 other events

Deaths: 0 deaths

Group 7: RSVpreF + BNT162b2 + QIV

Serious events: 3 serious events

Other events: 122 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=154 participants at risk 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=153 participants at risk 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.	Group 3: BNT162b2 + Placebo n=150 participants at risk Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo n=152 participants at risk Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo n=149 participants at risk Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo n=157 participants at risk Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV n=158 participants at risk Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.65% 1/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
General disorders Chest pain	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.66% 1/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.67% 1/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Hepatobiliary disorders Cholecystitis	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.64% 1/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Infections and infestations Cellulitis	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.63% 1/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Infections and infestations Pneumonia	0.65% 1/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Infections and infestations Sepsis	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.63% 1/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.67% 1/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.63% 1/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.65% 1/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.63% 1/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Nervous system disorders Cerebellar ataxia	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.67% 1/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Nervous system disorders Ischaemic stroke	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.67% 1/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Nervous system disorders Middle cerebral artery stroke	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.66% 1/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Nervous system disorders Thalamic stroke	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.67% 1/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Nervous system disorders Tremor	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.67% 1/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Reproductive system and breast disorders Cystocele	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.67% 1/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Reproductive system and breast disorders Rectocele	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.67% 1/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.67% 1/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.

Other adverse events

Measure	Group 1: [RSVpreF + BNT162b2] + QIV n=154 participants at risk 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.	Group 2: [RSVpreF+BNT162b2] + Placebo n=153 participants at risk 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.	Group 3: BNT162b2 + Placebo n=150 participants at risk Participants were randomized to receive BNT162b2 as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 4: RSVpreF + Placebo n=152 participants at risk Participants were randomized to receive RSVpreF as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 5: QIV + Placebo n=149 participants at risk Participants were randomized to receive QIV as a single intramuscular injection along with placebo as intramuscular injection on Day 1.	Group 6: RSVpreF + BNT162b2 + Placebo n=157 participants at risk Participants were randomized to receive RSVpreF + BNT162b2 + Placebo as a single intramuscular injection on Day 1.	Group 7: RSVpreF + BNT162b2 + QIV n=158 participants at risk Participants were randomized to receive RSVpreF + BNT162b2 + QIV as a single intramuscular injection on Day 1.
Gastrointestinal disorders Diarrhoea	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	1.3% 2/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Gastrointestinal disorders Diarrhoea (DIARRHEA)	11.0% 17/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	3.3% 5/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	5.3% 8/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	10.5% 16/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	9.4% 14/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	4.5% 7/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	12.7% 20/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Gastrointestinal disorders Vomiting (VOMITING)	1.9% 3/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	1.3% 2/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	2.6% 4/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.67% 1/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.64% 1/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	1.3% 2/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
General disorders Chills (CHILLS)	10.4% 16/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	7.8% 12/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	9.3% 14/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	3.9% 6/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	2.0% 3/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	10.2% 16/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	10.8% 17/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
General disorders Fatigue (FATIGUE)	42.2% 65/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	37.3% 57/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	35.3% 53/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	24.3% 37/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	28.9% 43/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	38.9% 61/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	46.8% 74/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
General disorders Injection site erythema (REDNESS)	7.8% 12/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	9.2% 14/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	7.3% 11/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	2.6% 4/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	4.0% 6/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	12.7% 20/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	8.9% 14/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
General disorders Injection site pain (PAIN AT THE INJECTION SITE)	57.1% 88/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	52.3% 80/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	62.7% 94/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	10.5% 16/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	51.7% 77/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	56.7% 89/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	53.8% 85/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
General disorders Injection site swelling (SWELLING)	5.2% 8/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	11.1% 17/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	9.3% 14/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	3.3% 5/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	6.0% 9/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	12.7% 20/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	7.0% 11/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
General disorders Pyrexia (FEVER)	3.9% 6/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	3.3% 5/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	1.3% 2/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	1.3% 2/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	1.9% 3/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	4.4% 7/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Infections and infestations COVID-19	0.00% 0/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	2.0% 3/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	1.9% 3/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.63% 1/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Musculoskeletal and connective tissue disorders Arthralgia (NEW OR WORSENED JOINT PAIN)	8.4% 13/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	7.2% 11/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	8.7% 13/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	5.9% 9/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	4.0% 6/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	10.2% 16/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	9.5% 15/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Musculoskeletal and connective tissue disorders Myalgia (NEW OR WORSENED MUSCLE PAIN)	13.0% 20/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	11.1% 17/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	10.7% 16/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	9.9% 15/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	10.7% 16/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	14.0% 22/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	14.6% 23/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Nervous system disorders Headache (HEADACHE)	21.4% 33/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	24.8% 38/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	22.7% 34/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	19.1% 29/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	12.8% 19/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	24.2% 38/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	19.0% 30/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.
Skin and subcutaneous tissue disorders Rash	1.9% 3/154 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/153 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/150 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/152 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/149 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/157 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.	0.00% 0/158 • Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1 Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER