Trial Outcomes & Findings for A Study to Learn About a Combined COVID-19 and Influenza Shot in Healthy Adults (NCT NCT06237049)

Last Updated: 2025-09-30

Results Overview

Local reactions included redness, swelling and pain at injection site, recorded by participants in an electronic diary (e-diary). Severity of all local reactions were evaluated as mild, moderate, severe or potentially life-threatening. In this outcome measure local reactions with any severity were reported for each left arm's deltoid and right arm's deltoid of each vaccine Group 1, 2, 3 and 4.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

644 participants

Primary outcome timeframe

Day 1 to Day 7 following Vaccination on Day 1

Results posted on

2025-09-30

Participant Flow

Participants were randomized to receive licensed Pfizer-BioNTech COVID-19 vaccine (BNT162b2 \[Omi XBB.1.5\]) 30 microgram (mcg) and recombinant influenza virus (RIV) vaccine 180 mcg together as a single injection or as 2 separate injections co-administered or BNT162b2 (Omi XBB.1.5) 30 mcg administered alone or RIV 180 mcg administered alone.

Participant milestones

Participant milestones
Measure	Group 1: BNT162b2 (Omi XBB.1.5)/ RIV + Placebo Participants were randomized to receive BNT162b2 (Omi XBB.1.5)/RIV together as a single intramuscular (IM) injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1.	Group 2: BNT162b2 (Omi XBB.1.5) + RIV Participants were randomized to receive BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid and RIV IM injection in the right deltoid on Day 1.	Group 3: BNT162b2 (Omi XBB.1.5) + Placebo Participants were randomized to receive BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1.	Group 4: RIV + Placebo Participants were randomized to receive RIV IM injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1.
Overall Study STARTED	160	163	160	161
Overall Study Vaccinated	160	161	160	160
Overall Study COMPLETED	145	155	151	151
Overall Study NOT COMPLETED	15	8	9	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: BNT162b2 (Omi XBB.1.5)/ RIV + Placebo Participants were randomized to receive BNT162b2 (Omi XBB.1.5)/RIV together as a single intramuscular (IM) injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1.	Group 2: BNT162b2 (Omi XBB.1.5) + RIV Participants were randomized to receive BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid and RIV IM injection in the right deltoid on Day 1.	Group 3: BNT162b2 (Omi XBB.1.5) + Placebo Participants were randomized to receive BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1.	Group 4: RIV + Placebo Participants were randomized to receive RIV IM injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1.
Overall Study Death	0	0	0	1
Overall Study Lost to Follow-up	11	5	8	8
Overall Study Protocol Violation	0	1	0	1
Overall Study Withdrawal by Subject	4	2	1	0

Baseline Characteristics

A Study to Learn About a Combined COVID-19 and Influenza Shot in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: BNT162b2 (Omi XBB.1.5)/ RIV + Placebo n=160 Participants Participants were randomized to receive BNT162b2 (Omi XBB.1.5)/RIV together as a single IM injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1.	Group 2: BNT162b2 (Omi XBB.1.5) + RIV n=161 Participants Participants were randomized to receive BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid and RIV IM injection in the right deltoid on Day 1.	Group 3: BNT162b2 (Omi XBB.1.5) + Placebo n=160 Participants Participants were randomized to receive BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1.	Group 4: RIV + Placebo n=160 Participants Participants were randomized to receive RIV IM injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1.	Total n=641 Participants Total of all reporting groups
Age, Continuous	63.9 Years STANDARD_DEVIATION 8.40 • n=5 Participants	63.9 Years STANDARD_DEVIATION 9.06 • n=7 Participants	62.9 Years STANDARD_DEVIATION 7.73 • n=5 Participants	63.9 Years STANDARD_DEVIATION 7.66 • n=4 Participants	63.7 Years STANDARD_DEVIATION 8.22 • n=21 Participants
Sex: Female, Male Female	87 Participants n=5 Participants	92 Participants n=7 Participants	100 Participants n=5 Participants	83 Participants n=4 Participants	362 Participants n=21 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	69 Participants n=7 Participants	60 Participants n=5 Participants	77 Participants n=4 Participants	279 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants	28 Participants n=7 Participants	29 Participants n=5 Participants	21 Participants n=4 Participants	106 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	132 Participants n=5 Participants	133 Participants n=7 Participants	131 Participants n=5 Participants	137 Participants n=4 Participants	533 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	20 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Black or African American	37 Participants n=5 Participants	38 Participants n=7 Participants	30 Participants n=5 Participants	30 Participants n=4 Participants	135 Participants n=21 Participants
Race (NIH/OMB) White	117 Participants n=5 Participants	111 Participants n=7 Participants	124 Participants n=5 Participants	117 Participants n=4 Participants	469 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 7 following Vaccination on Day 1

Population: SAS consisted of all participants who received at least 1 dose of the study intervention. As planned, results of this outcome measure are reported for vaccination in each arm (left and right deltoid- as separate reporting arm) of each vaccine group.

Outcome measures

Outcome measures
Measure	Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV n=160 Participants Participants received BNT162b2/RIV as a single IM injection in the left deltoid.	Group 1, BNT162b2/RIV + Placebo: Placebo n=160 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 2, BNT162b2 + RIV: BNT162b2 n=161 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 2, BNT162b2 + RIV: RIV n=161 Participants Participants received RIV IM injection in the right deltoid.	Group 3, BNT162b2 + Placebo: BNT162b2 n=160 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 3, BNT162b2 + Placebo: Placebo n=160 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 4, RIV + Placebo: RIV n=160 Participants Participants received RIV IM injection in the left deltoid.	Group 4, RIV + Placebo: Placebo n=160 Participants Participants received normal saline placebo IM injection in the right deltoid.
Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination Pain at injection site	56.3 Percentage of participants Interval 48.2 to 64.1	11.9 Percentage of participants Interval 7.3 to 17.9	59.0 Percentage of participants Interval 51.0 to 66.7	38.5 Percentage of participants Interval 31.0 to 46.5	62.5 Percentage of participants Interval 54.5 to 70.0	9.4 Percentage of participants Interval 5.3 to 15.0	36.9 Percentage of participants Interval 29.4 to 44.9	8.1 Percentage of participants Interval 4.4 to 13.5
Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination Redness	8.8 Percentage of participants Interval 4.9 to 14.2	1.3 Percentage of participants Interval 0.2 to 4.4	5.0 Percentage of participants Interval 2.2 to 9.6	3.1 Percentage of participants Interval 1.0 to 7.1	5.0 Percentage of participants Interval 2.2 to 9.6	0.6 Percentage of participants Interval 0.0 to 3.4	6.3 Percentage of participants Interval 3.0 to 11.2	0.6 Percentage of participants Interval 0.0 to 3.4
Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination Swelling	9.4 Percentage of participants Interval 5.3 to 15.0	1.3 Percentage of participants Interval 0.2 to 4.4	6.2 Percentage of participants Interval 3.0 to 11.1	3.1 Percentage of participants Interval 1.0 to 7.1	5.6 Percentage of participants Interval 2.6 to 10.4	0.6 Percentage of participants Interval 0.0 to 3.4	5.0 Percentage of participants Interval 2.2 to 9.6	0.6 Percentage of participants Interval 0.0 to 3.4

PRIMARY outcome

Timeframe: Day 1 to Day 7 following Vaccination on Day 1

Population: SAS consisted of all participants who received at least 1 dose of the study intervention. Data is presented for each vaccine group.

Systemic events: fever, fatigue, headache, vomiting, diarrhea, chills, new/worsened muscle pain, new/worsened joint pain were recorded by participants in e-diary. Severity of all systemic events were evaluated as mild, moderate, severe or potentially life-threatening. In this outcome measure systemic events with any severity were reported.

Outcome measures

Outcome measures
Measure	Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV n=160 Participants Participants received BNT162b2/RIV as a single IM injection in the left deltoid.	Group 1, BNT162b2/RIV + Placebo: Placebo n=161 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 2, BNT162b2 + RIV: BNT162b2 n=160 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 2, BNT162b2 + RIV: RIV n=160 Participants Participants received RIV IM injection in the right deltoid.	Group 3, BNT162b2 + Placebo: BNT162b2 Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 3, BNT162b2 + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.	Group 4, RIV + Placebo: RIV Participants received RIV IM injection in the left deltoid.	Group 4, RIV + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.
Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination Fever	1.9 Percentage of participants Interval 0.4 to 5.4	6.2 Percentage of participants Interval 3.0 to 11.1	6.3 Percentage of participants Interval 3.0 to 11.2	0 Percentage of participants Interval 0.0 to 2.3	—	—	—	—
Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination Fatigue	36.3 Percentage of participants Interval 28.8 to 44.2	39.1 Percentage of participants Interval 31.5 to 47.1	40.6 Percentage of participants Interval 32.9 to 48.7	33.1 Percentage of participants Interval 25.9 to 41.0	—	—	—	—
Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination Headache	24.4 Percentage of participants Interval 17.9 to 31.8	31.1 Percentage of participants Interval 24.0 to 38.8	26.9 Percentage of participants Interval 20.2 to 34.4	16.9 Percentage of participants Interval 11.4 to 23.6	—	—	—	—
Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination Vomiting	0 Percentage of participants Interval 0.0 to 2.3	3.1 Percentage of participants Interval 1.0 to 7.1	1.9 Percentage of participants Interval 0.4 to 5.4	0 Percentage of participants Interval 0.0 to 2.3	—	—	—	—
Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination Diarrhea	8.1 Percentage of participants Interval 4.4 to 13.5	11.2 Percentage of participants Interval 6.8 to 17.1	11.3 Percentage of participants Interval 6.8 to 17.2	7.5 Percentage of participants Interval 3.9 to 12.7	—	—	—	—
Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination Chills	8.8 Percentage of participants Interval 4.9 to 14.2	14.9 Percentage of participants Interval 9.8 to 21.4	15.0 Percentage of participants Interval 9.9 to 21.5	6.9 Percentage of participants Interval 3.5 to 12.0	—	—	—	—
Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination New or worsened muscle pain	13.1 Percentage of participants Interval 8.3 to 19.4	22.4 Percentage of participants Interval 16.2 to 29.6	15.0 Percentage of participants Interval 9.9 to 21.5	8.1 Percentage of participants Interval 4.4 to 13.5	—	—	—	—
Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination New or worsened joint pain	7.5 Percentage of participants Interval 3.9 to 12.7	13.7 Percentage of participants Interval 8.8 to 20.0	10.0 Percentage of participants Interval 5.8 to 15.7	4.4 Percentage of participants Interval 1.8 to 8.8	—	—	—	—

PRIMARY outcome

Timeframe: From Vaccination on Day 1 through 4 weeks after Vaccination

Population: SAS consisted of all participants who received at least 1 dose of the study intervention. Data is presented for each vaccine group.

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. Events collected by systematic assessment (local reactions and systemic events) were excluded from evaluation.

Outcome measures

Outcome measures
Measure	Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV n=160 Participants Participants received BNT162b2/RIV as a single IM injection in the left deltoid.	Group 1, BNT162b2/RIV + Placebo: Placebo n=161 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 2, BNT162b2 + RIV: BNT162b2 n=160 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 2, BNT162b2 + RIV: RIV n=160 Participants Participants received RIV IM injection in the right deltoid.	Group 3, BNT162b2 + Placebo: BNT162b2 Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 3, BNT162b2 + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.	Group 4, RIV + Placebo: RIV Participants received RIV IM injection in the left deltoid.	Group 4, RIV + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.
Percentage of Participants Who Reported Any Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination	4.4 Percentage of participants Interval 1.8 to 8.8	3.7 Percentage of participants Interval 1.4 to 7.9	5.6 Percentage of participants Interval 2.6 to 10.4	5.6 Percentage of participants Interval 2.6 to 10.4	—	—	—	—

PRIMARY outcome

Timeframe: From Vaccination on Day 1 through 6 months after Vaccination

Population: SAS consisted of all participants who received at least 1 dose of the study intervention. Data is presented for each vaccine group.

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the 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 other important medical events per protocol of the study. Events collected by systematic assessment (local reactions and systemic events) were excluded from evaluation.

Outcome measures

Outcome measures
Measure	Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV n=160 Participants Participants received BNT162b2/RIV as a single IM injection in the left deltoid.	Group 1, BNT162b2/RIV + Placebo: Placebo n=161 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 2, BNT162b2 + RIV: BNT162b2 n=160 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 2, BNT162b2 + RIV: RIV n=160 Participants Participants received RIV IM injection in the right deltoid.	Group 3, BNT162b2 + Placebo: BNT162b2 Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 3, BNT162b2 + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.	Group 4, RIV + Placebo: RIV Participants received RIV IM injection in the left deltoid.	Group 4, RIV + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.
Percentage of Participants Who Reported Any Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination	1.9 Percentage of participants Interval 0.4 to 5.4	0.6 Percentage of participants Interval 0.0 to 3.4	0 Percentage of participants Interval 0.0 to 2.3	1.9 Percentage of participants Interval 0.4 to 5.4	—	—	—	—

PRIMARY outcome

Timeframe: Before Vaccination on Day 1

Population: Evaluable immunogenicity population (EIP) included all eligible participants who received study intervention, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination, and had no other important protocol deviations as determined by the clinician. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

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). As planned, outcome measure evaluated GMTs of SARS-CoV-2 Omicron (XBB.1.5), hence results are reported only for those reporting groups where BNT162b2 (Omi XBB.1.5) was administered. Data was not collected and not reported for reporting group "Group 4: RIV + Placebo", where BNT162b2 (Omi XBB.1.5) was not administered.

Outcome measures

Outcome measures
Measure	Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV n=151 Participants Participants received BNT162b2/RIV as a single IM injection in the left deltoid.	Group 1, BNT162b2/RIV + Placebo: Placebo n=157 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 2, BNT162b2 + RIV: BNT162b2 n=154 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 2, BNT162b2 + RIV: RIV Participants received RIV IM injection in the right deltoid.	Group 3, BNT162b2 + Placebo: BNT162b2 Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 3, BNT162b2 + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.	Group 4, RIV + Placebo: RIV Participants received RIV IM injection in the left deltoid.	Group 4, RIV + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.
Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Omicron (XBB.1.5)-Neutralizing Titers Before Vaccination	311.2 Titer Interval 236.2 to 409.9	285.4 Titer Interval 220.4 to 369.5	338.5 Titer Interval 256.9 to 446.0	—	—	—	—	—

PRIMARY outcome

Timeframe: At 4 weeks after Vaccination on Day 1

Population: EIP included all eligible participants who received study intervention, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination, and had no other important protocol deviations as determined by the clinician. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV n=151 Participants Participants received BNT162b2/RIV as a single IM injection in the left deltoid.	Group 1, BNT162b2/RIV + Placebo: Placebo n=158 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 2, BNT162b2 + RIV: BNT162b2 n=152 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 2, BNT162b2 + RIV: RIV Participants received RIV IM injection in the right deltoid.	Group 3, BNT162b2 + Placebo: BNT162b2 Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 3, BNT162b2 + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.	Group 4, RIV + Placebo: RIV Participants received RIV IM injection in the left deltoid.	Group 4, RIV + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.
GMTs of SARS-CoV-2 Omicron (XBB.1.5)-Neutralizing Titers at 4 Weeks After Vaccination	2162.4 Titer Interval 1719.6 to 2719.4	2581.3 Titer Interval 2076.2 to 3209.5	3644.7 Titer Interval 2853.7 to 4654.8	—	—	—	—	—

PRIMARY outcome

Timeframe: From before Vaccination on Day 1 to 4 weeks after Vaccination

GMFR was the ratio of the geometric mean titre values 4 weeks after vaccination to before vaccination. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). As planned, outcome measure evaluated GMTs of SARS-CoV-2 Omicron (XBB.1.5), hence results are reported only for those reporting groups where BNT162b2 (Omi XBB.1.5) was administered. Data was not collected and not reported for reporting group "Group 4: RIV + Placebo", where BNT162b2 (Omi XBB.1.5) was not administered.

Outcome measures

Outcome measures
Measure	Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV n=149 Participants Participants received BNT162b2/RIV as a single IM injection in the left deltoid.	Group 1, BNT162b2/RIV + Placebo: Placebo n=157 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 2, BNT162b2 + RIV: BNT162b2 n=152 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 2, BNT162b2 + RIV: RIV Participants received RIV IM injection in the right deltoid.	Group 3, BNT162b2 + Placebo: BNT162b2 Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 3, BNT162b2 + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.	Group 4, RIV + Placebo: RIV Participants received RIV IM injection in the left deltoid.	Group 4, RIV + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron (XBB.1.5)-Neutralizing Titers From Before Vaccination to 4 Weeks After Vaccination	6.1 Ratio Interval 4.7 to 7.9	8.0 Ratio Interval 6.3 to 10.1	9.4 Ratio Interval 7.2 to 12.3	—	—	—	—	—

PRIMARY outcome

Timeframe: At 4 weeks after Vaccination on Day 1

Seroresponse was defined as achieving a \>=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the lower limit of quantification (LLOQ), the postvaccination measure of \>=4\*LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method. As planned, outcome measure evaluated GMTs of SARS-CoV-2 Omicron (XBB.1.5), hence results are reported only for those reporting groups where BNT162b2 (Omi XBB.1.5) was administered. Data was not collected and not reported for reporting group "Group 4: RIV + Placebo", where BNT162b2 (Omi XBB.1.5) was not administered.

Outcome measures

Outcome measures
Measure	Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV n=149 Participants Participants received BNT162b2/RIV as a single IM injection in the left deltoid.	Group 1, BNT162b2/RIV + Placebo: Placebo n=157 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 2, BNT162b2 + RIV: BNT162b2 n=152 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 2, BNT162b2 + RIV: RIV Participants received RIV IM injection in the right deltoid.	Group 3, BNT162b2 + Placebo: BNT162b2 Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 3, BNT162b2 + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.	Group 4, RIV + Placebo: RIV Participants received RIV IM injection in the left deltoid.	Group 4, RIV + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.
Percentages of Participants With Seroresponse to SARS-CoV-2 Omicron (XBB.1.5) at 4 Weeks After Vaccination	53.7 Percentage of participants Interval 45.3 to 61.9	60.5 Percentage of participants Interval 52.4 to 68.2	63.8 Percentage of participants Interval 55.6 to 71.4	—	—	—	—	—

PRIMARY outcome

Timeframe: Before Vaccination on Day 1

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). The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As planned, outcome measure evaluated GMTs of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group "Group 3: BNT162b2 (Omi XBB.1.5) + Placebo", where RIV was not administered.

Outcome measures

Outcome measures
Measure	Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV n=153 Participants Participants received BNT162b2/RIV as a single IM injection in the left deltoid.	Group 1, BNT162b2/RIV + Placebo: Placebo n=158 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 2, BNT162b2 + RIV: BNT162b2 n=155 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 2, BNT162b2 + RIV: RIV Participants received RIV IM injection in the right deltoid.	Group 3, BNT162b2 + Placebo: BNT162b2 Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 3, BNT162b2 + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.	Group 4, RIV + Placebo: RIV Participants received RIV IM injection in the left deltoid.	Group 4, RIV + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.
GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination A/Victoria/4897/ 2022 (H1N1) HAI	43.8 Titer Interval 33.9 to 56.5	60.7 Titer Interval 47.7 to 77.1	62.6 Titer Interval 49.0 to 79.8	—	—	—	—	—
GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination A/Darwin/9/ 2021 (H3N2) HAI	34.8 Titer Interval 26.8 to 45.1	42.3 Titer Interval 32.7 to 54.9	44.3 Titer Interval 33.8 to 58.1	—	—	—	—	—
GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination B/Michigan/1/ 2021 HAI	105.9 Titer Interval 82.4 to 136.2	101.8 Titer Interval 81.4 to 127.4	114.9 Titer Interval 92.0 to 143.6	—	—	—	—	—
GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination B/Phuket/3073/ 2013 HAI	186.6 Titer Interval 151.8 to 229.5	218.5 Titer Interval 181.3 to 263.2	228.8 Titer Interval 185.9 to 281.7	—	—	—	—	—

PRIMARY outcome

Timeframe: At 4 weeks after Vaccination on Day 1

Outcome measures

Outcome measures
Measure	Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV n=153 Participants Participants received BNT162b2/RIV as a single IM injection in the left deltoid.	Group 1, BNT162b2/RIV + Placebo: Placebo n=158 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 2, BNT162b2 + RIV: BNT162b2 n=155 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 2, BNT162b2 + RIV: RIV Participants received RIV IM injection in the right deltoid.	Group 3, BNT162b2 + Placebo: BNT162b2 Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 3, BNT162b2 + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.	Group 4, RIV + Placebo: RIV Participants received RIV IM injection in the left deltoid.	Group 4, RIV + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.
GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination A/Victoria/4897/ 2022 (H1N1) HAI	324.4 Titer Interval 250.4 to 420.2	374.7 Titer Interval 299.4 to 469.1	389.6 Titer Interval 309.4 to 490.5	—	—	—	—	—
GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination A/Darwin/9/ 2021 (H3N2) HAI	397.7 Titer Interval 310.4 to 509.7	489.7 Titer Interval 393.9 to 608.9	557.2 Titer Interval 440.8 to 704.2	—	—	—	—	—
GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination B/Michigan/1/ 2021 HAI	464.0 Titer Interval 384.5 to 559.9	427.5 Titer Interval 360.0 to 507.6	496.0 Titer Interval 408.6 to 602.1	—	—	—	—	—
GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination B/Phuket/3073/ 2013 HAI	669.7 Titer Interval 568.4 to 789.0	769.5 Titer Interval 658.9 to 898.7	775.7 Titer Interval 656.1 to 917.1	—	—	—	—	—

PRIMARY outcome

Timeframe: From before Vaccination to 4 weeks after Vaccination on Day 1

GMFR was the ratio of the geometric mean titre values 4 weeks after vaccination to before vaccination. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As planned, outcome measure evaluated GMFRs of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group "Group 3: BNT162b2 (Omi XBB.1.5) + Placebo", where RIV was not administered.

Outcome measures

Outcome measures
Measure	Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV n=153 Participants Participants received BNT162b2/RIV as a single IM injection in the left deltoid.	Group 1, BNT162b2/RIV + Placebo: Placebo n=158 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 2, BNT162b2 + RIV: BNT162b2 n=155 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 2, BNT162b2 + RIV: RIV Participants received RIV IM injection in the right deltoid.	Group 3, BNT162b2 + Placebo: BNT162b2 Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 3, BNT162b2 + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.	Group 4, RIV + Placebo: RIV Participants received RIV IM injection in the left deltoid.	Group 4, RIV + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.
GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination A/Victoria/4897/ 2022 (H1N1) HAI	6.6 Ratio Interval 5.2 to 8.5	5.7 Ratio Interval 4.5 to 7.2	5.7 Ratio Interval 4.5 to 7.2	—	—	—	—	—
GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination A/Darwin/9/ 2021 (H3N2) HAI	9.9 Ratio Interval 7.7 to 12.6	10.1 Ratio Interval 8.0 to 12.8	11.0 Ratio Interval 8.5 to 14.3	—	—	—	—	—
GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination B/Michigan/1/ 2021 HAI	4.3 Ratio Interval 3.5 to 5.3	4.1 Ratio Interval 3.4 to 5.0	4.2 Ratio Interval 3.3 to 5.4	—	—	—	—	—
GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination B/Phuket/3073/ 2013 HAI	3.6 Ratio Interval 2.9 to 4.4	3.5 Ratio Interval 2.9 to 4.2	3.4 Ratio Interval 2.8 to 4.1	—	—	—	—	—

PRIMARY outcome

Timeframe: At 4 weeks after Vaccination on Day 1

Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a minimum 4-fold rise at the time point of interest. Exact 2-sided CI, based on the Clopper and Pearson method. The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As planned, outcome measure evaluated seroconversion of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group "Group 3: BNT162b2 (Omi XBB.1.5) + Placebo", where RIV was not administered.

Outcome measures

Outcome measures
Measure	Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV n=153 Participants Participants received BNT162b2/RIV as a single IM injection in the left deltoid.	Group 1, BNT162b2/RIV + Placebo: Placebo n=158 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 2, BNT162b2 + RIV: BNT162b2 n=155 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 2, BNT162b2 + RIV: RIV Participants received RIV IM injection in the right deltoid.	Group 3, BNT162b2 + Placebo: BNT162b2 Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 3, BNT162b2 + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.	Group 4, RIV + Placebo: RIV Participants received RIV IM injection in the left deltoid.	Group 4, RIV + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.
Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination A/Victoria/4897/ 2022 (H1N1) HAI	62.7 Percentage of participants Interval 54.6 to 70.4	67.7 Percentage of participants Interval 59.8 to 74.9	61.3 Percentage of participants Interval 53.1 to 69.0	—	—	—	—	—
Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination A/Darwin/9/2021 (H3N2)	76.5 Percentage of participants Interval 68.9 to 82.9	79.1 Percentage of participants Interval 71.9 to 85.2	76.1 Percentage of participants Interval 68.6 to 82.6	—	—	—	—	—
Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination B/Michigan/1/2021	54.9 Percentage of participants Interval 46.7 to 62.9	53.2 Percentage of participants Interval 45.1 to 61.1	51.0 Percentage of participants Interval 42.8 to 59.1	—	—	—	—	—
Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination B/Phuket/3073/2013	49.7 Percentage of participants Interval 41.5 to 57.9	53.8 Percentage of participants Interval 45.7 to 61.8	46.5 Percentage of participants Interval 38.4 to 54.6	—	—	—	—	—

PRIMARY outcome

Timeframe: Before Vaccination on Day 1

Percentages of participants with HAI titers \>= 1:40 before vaccination along with the associated 2-sided 95% CIs, was provided for each vaccine group in this outcome measure. Exact 2-sided CI, based on the Clopper and Pearson method. The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As planned, outcome measure evaluated of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group "Group 3: BNT162b2 (Omi XBB.1.5) + Placebo", where RIV was not administered.

Outcome measures

Outcome measures
Measure	Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV n=153 Participants Participants received BNT162b2/RIV as a single IM injection in the left deltoid.	Group 1, BNT162b2/RIV + Placebo: Placebo n=158 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 2, BNT162b2 + RIV: BNT162b2 n=155 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 2, BNT162b2 + RIV: RIV Participants received RIV IM injection in the right deltoid.	Group 3, BNT162b2 + Placebo: BNT162b2 Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 3, BNT162b2 + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.	Group 4, RIV + Placebo: RIV Participants received RIV IM injection in the left deltoid.	Group 4, RIV + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.
Percentages of Participants With HAI Titers >= 1:40 Before Vaccination A/Victoria/4897/ 2022 (H1N1) HAI	55.6 Percentage of participants Interval 47.3 to 63.6	69.6 Percentage of participants Interval 61.8 to 76.7	70.3 Percentage of participants Interval 62.5 to 77.4	—	—	—	—	—
Percentages of Participants With HAI Titers >= 1:40 Before Vaccination A/Darwin/9/2021 (H3N2)	49.7 Percentage of participants Interval 41.5 to 57.9	57.6 Percentage of participants Interval 49.5 to 65.4	54.8 Percentage of participants Interval 46.7 to 62.8	—	—	—	—	—
Percentages of Participants With HAI Titers >= 1:40 Before Vaccination B/Michigan/1/2021	74.5 Percentage of participants Interval 66.8 to 81.2	81.6 Percentage of participants Interval 74.7 to 87.3	81.3 Percentage of participants Interval 74.2 to 87.1	—	—	—	—	—
Percentages of Participants With HAI Titers >= 1:40 Before Vaccination B/Phuket/3073/2013	89.5 Percentage of participants Interval 83.6 to 93.9	94.3 Percentage of participants Interval 89.5 to 97.4	93.5 Percentage of participants Interval 88.5 to 96.9	—	—	—	—	—

PRIMARY outcome

Timeframe: At 4 Weeks after Vaccination on Day 1

Percentages of participants with HAI titers \>= 1:40 at 4 weeks after vaccination along with the associated 2-sided 95% CIs, was provided for each vaccine group in this outcome measure. Exact 2-sided CI, based on the Clopper and Pearson method. The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As outcome measure evaluated of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group "Group 3: BNT162b2 (Omi XBB.1.5) + Placebo", where RIV was not administered.

Outcome measures

Outcome measures
Measure	Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV n=153 Participants Participants received BNT162b2/RIV as a single IM injection in the left deltoid.	Group 1, BNT162b2/RIV + Placebo: Placebo n=158 Participants Participants received normal saline placebo IM injection in the right deltoid.	Group 2, BNT162b2 + RIV: BNT162b2 n=155 Participants Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 2, BNT162b2 + RIV: RIV Participants received RIV IM injection in the right deltoid.	Group 3, BNT162b2 + Placebo: BNT162b2 Participants received BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid.	Group 3, BNT162b2 + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.	Group 4, RIV + Placebo: RIV Participants received RIV IM injection in the left deltoid.	Group 4, RIV + Placebo: Placebo Participants received normal saline placebo IM injection in the right deltoid.
Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination A/Victoria/4897/ 2022 (H1N1) HAI	90.8 Percentage of participants Interval 85.1 to 94.9	95.6 Percentage of participants Interval 91.1 to 98.2	96.8 Percentage of participants Interval 92.6 to 98.9	—	—	—	—	—
Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination A/Darwin/9/2021 (H3N2)	95.4 Percentage of participants Interval 90.8 to 98.1	97.5 Percentage of participants Interval 93.6 to 99.3	96.1 Percentage of participants Interval 91.8 to 98.6	—	—	—	—	—
Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination B/Michigan/1/2021	98.0 Percentage of participants Interval 94.4 to 99.6	100.0 Percentage of participants Interval 97.7 to 100.0	99.4 Percentage of participants Interval 96.5 to 100.0	—	—	—	—	—
Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination B/Phuket/3073/2013	99.3 Percentage of participants Interval 96.4 to 100.0	100.0 Percentage of participants Interval 97.7 to 100.0	100.0 Percentage of participants Interval 97.6 to 100.0	—	—	—	—	—

Adverse Events

Group 1: BNT162b2 (Omi XBB.1.5)/ RIV + Placebo

Serious events: 3 serious events

Other events: 114 other events

Deaths: 0 deaths

Group 2: BNT162b2 (Omi XBB.1.5) + RIV

Serious events: 1 serious events

Other events: 117 other events

Deaths: 0 deaths

Group 3: BNT162b2 (Omi XBB.1.5) + Placebo

Serious events: 0 serious events

Other events: 115 other events

Deaths: 0 deaths

Group 4: RIV + Placebo

Serious events: 3 serious events

Other events: 88 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Group 1: BNT162b2 (Omi XBB.1.5)/ RIV + Placebo n=160 participants at risk Participants were randomized to receive BNT162b2 (Omi XBB.1.5)//RIV together as a single IM injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1.	Group 2: BNT162b2 (Omi XBB.1.5) + RIV n=161 participants at risk Participants were randomized to receive BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid and RIV IM injection in the right deltoid on Day 1.	Group 3: BNT162b2 (Omi XBB.1.5) + Placebo n=160 participants at risk Participants were randomized to receive BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1.	Group 4: RIV + Placebo n=160 participants at risk Participants were randomized to receive RIV IM injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1.
General disorders Death	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/161 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.62% 1/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.
Infections and infestations Appendicitis	0.62% 1/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/161 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.
Infections and infestations Infected skin ulcer	0.62% 1/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/161 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.
Infections and infestations Localised infection	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/161 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.62% 1/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.
Infections and infestations Urinary tract infection	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/161 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.62% 1/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.62% 1/161 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/161 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.62% 1/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.
Nervous system disorders Transient ischaemic attack	0.62% 1/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/161 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/161 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.62% 1/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/161 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.62% 1/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/161 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.00% 0/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.	0.62% 1/160 • AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination 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 consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.

Other adverse events

Additional Information

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