Trial Outcomes & Findings for Clinical Trial to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among HCP (NCT NCT06054269)

Last Updated: 2025-05-29

Results Overview

The geometric mean of antibody titers after a single dose of FLUAD Quadrivalent (adjuvanted dose, AD) vs. FluQuadri (standard dose, SD) as measured by HI assay for egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses at approximately 28 days post-vaccination

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

192 participants

Primary outcome timeframe

28 days post-vaccination

Results posted on

2025-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	FLUAD Quadrivalent Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain). FLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent	FluQuadri Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain). FluQuadri: 0.5 mL intramuscular dose of FluQuadri
Overall Study STARTED	95	97
Overall Study Provided 28 Days Post-vaccination Blood Specimen	95	95
Overall Study Provided 6 Months Post-vaccination Blood Specimen	94	96
Overall Study COMPLETED	95	97
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among HCP

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FLUAD Quadrivalent n=95 Participants Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain). FLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent	FluQuadri n=97 Participants Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain). FluQuadri: 0.5 mL intramuscular dose of FluQuadri	Total n=192 Participants Total of all reporting groups
Age, Customized Age group · 18-50 years old	47 Participants n=5 Participants	56 Participants n=7 Participants	103 Participants n=5 Participants
Age, Customized Age group · 50-65 years old	46 Participants n=5 Participants	34 Participants n=7 Participants	80 Participants n=5 Participants
Age, Customized Age group · >65 years old	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	56 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	41 Participants n=7 Participants	80 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Mixed	77 Participants n=5 Participants	89 Participants n=7 Participants	166 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Quechua	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · African Peruvian	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Caucasian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Aymara	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Body mass index Healthy (18.5-24.9)	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Body mass index Overweight (25.0-29.9)	50 Participants n=5 Participants	45 Participants n=7 Participants	95 Participants n=5 Participants
Body mass index Obese (>=30.0)	35 Participants n=5 Participants	36 Participants n=7 Participants	71 Participants n=5 Participants
Current smoking habit Non-smoker	85 Participants n=5 Participants	91 Participants n=7 Participants	176 Participants n=5 Participants
Current smoking habit Smoke periodically-daily	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
History of chronic conditions No	81 Participants n=5 Participants	81 Participants n=7 Participants	162 Participants n=5 Participants
History of chronic conditions Yes	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days post-vaccination

Outcome measures

Outcome measures
Measure	FLUAD Quadrivalent n=95 Participants Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain). FLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent	FluQuadri n=95 Participants Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain). FluQuadri: 0.5 mL intramuscular dose of FluQuadri
Hemagglutination Inhibition (HI) Geometric Mean Titers (GMT) Post-vaccination (Day 28) of Each Vaccine Reference Virus Influenza A(H1N1)pdm09	584.2 antibody titer Interval 453.1 to 753.3	342.8 antibody titer Interval 265.9 to 442.0
Hemagglutination Inhibition (HI) Geometric Mean Titers (GMT) Post-vaccination (Day 28) of Each Vaccine Reference Virus Influenza A(H3N2)	217.4 antibody titer Interval 173.0 to 273.1	169.0 antibody titer Interval 134.5 to 212.3
Hemagglutination Inhibition (HI) Geometric Mean Titers (GMT) Post-vaccination (Day 28) of Each Vaccine Reference Virus Influenza B/Victoria	102.1 antibody titer Interval 76.5 to 136.2	107.8 antibody titer Interval 80.8 to 143.9
Hemagglutination Inhibition (HI) Geometric Mean Titers (GMT) Post-vaccination (Day 28) of Each Vaccine Reference Virus Influenza B/Yamagata	211.1 antibody titer Interval 170.5 to 261.4	184.4 antibody titer Interval 148.9 to 228.4

PRIMARY outcome

Timeframe: 6 months post-vaccination

The geometric mean of antibody titers after a single dose of AD vs SD vaccine as measured by HI assay for egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses at approximately 6 months post-vaccination

Outcome measures

Outcome measures
Measure	FLUAD Quadrivalent n=94 Participants Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain). FLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent	FluQuadri n=96 Participants Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain). FluQuadri: 0.5 mL intramuscular dose of FluQuadri
HI GMT Post-vaccination (6 Months) of Each Vaccine Reference Virus Influenza A(H1N1)pdm09	177.4 antibody titer Interval 137.2 to 229.3	128.4 antibody titer Interval 99.6 to 165.5
HI GMT Post-vaccination (6 Months) of Each Vaccine Reference Virus Influenza A(H3N2)	94.1 antibody titer Interval 75.0 to 118.0	67.2 antibody titer Interval 53.7 to 84.1
HI GMT Post-vaccination (6 Months) of Each Vaccine Reference Virus Influenza B/Victoria	34.5 antibody titer Interval 25.8 to 46.1	41.2 antibody titer Interval 30.9 to 54.9
HI GMT Post-vaccination (6 Months) of Each Vaccine Reference Virus Influenza B/Yamagata	55.5 antibody titer Interval 43.2 to 71.4	57.0 antibody titer Interval 44.4 to 73.0

PRIMARY outcome

Timeframe: 28 days post-vaccination

The percent of participants with paired samples that achieved ≥4-fold rises comparing post- (approximately 28 days) versus pre-vaccination titers, and post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.

Outcome measures

Outcome measures
Measure	FLUAD Quadrivalent n=95 Participants Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain). FLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent	FluQuadri n=95 Participants Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain). FluQuadri: 0.5 mL intramuscular dose of FluQuadri
Seroconversion Rate (SCR) to Each Vaccine Reference Virus Post-vaccination Influenza A(H1N1)pdm09	88.4 percentage of participants Interval 80.4 to 93.4	62.1 percentage of participants Interval 52.1 to 71.2
Seroconversion Rate (SCR) to Each Vaccine Reference Virus Post-vaccination Influenza A(H3N2)	82.1 percentage of participants Interval 73.2 to 88.5	62.1 percentage of participants Interval 52.1 to 71.2
Seroconversion Rate (SCR) to Each Vaccine Reference Virus Post-vaccination Influenza B/Victoria	47.4 percentage of participants Interval 37.6 to 57.3	52.6 percentage of participants Interval 42.7 to 62.4
Seroconversion Rate (SCR) to Each Vaccine Reference Virus Post-vaccination Influenza B/Yamagata	63.2 percentage of participants Interval 53.1 to 72.2	49.5 percentage of participants Interval 39.6 to 59.4

PRIMARY outcome

Timeframe: 6 months post-vaccination

The percent of participants with paired samples that achieved ≥4-fold rises comparing post- (approximately 6 months) versus pre-vaccination titers, and post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.

Outcome measures

Outcome measures
Measure	FLUAD Quadrivalent n=94 Participants Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain). FLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent	FluQuadri n=96 Participants Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain). FluQuadri: 0.5 mL intramuscular dose of FluQuadri
SCR to Each Vaccine Reference Virus Post-vaccination Influenza A(H1N1)pdm09	53.2 percentage of participants Interval 43.2 to 63.0	41.7 percentage of participants Interval 32.3 to 51.7
SCR to Each Vaccine Reference Virus Post-vaccination Influenza A(H3N2)	50.0 percentage of participants Interval 40.1 to 59.9	39.6 percentage of participants Interval 30.4 to 49.6
SCR to Each Vaccine Reference Virus Post-vaccination Influenza B/Victoria	18.1 percentage of participants Interval 11.6 to 27.1	28.1 percentage of participants Interval 20.1 to 37.8
SCR to Each Vaccine Reference Virus Post-vaccination Influenza B/Yamagata	16.0 percentage of participants Interval 9.9 to 24.7	10.4 percentage of participants Interval 5.8 to 18.1

PRIMARY outcome

Timeframe: 28 days post-vaccination

The percent of participants with post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.

Outcome measures

Outcome measures
Measure	FLUAD Quadrivalent n=95 Participants Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain). FLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent	FluQuadri n=95 Participants Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain). FluQuadri: 0.5 mL intramuscular dose of FluQuadri
Seroprotection Rate (SPR) to Each Vaccine Reference Virus Post-vaccination Influenza A(H1N1)pdm09	98.9 percentage of participants Interval 94.3 to 99.9	94.7 percentage of participants Interval 88.3 to 97.7
Seroprotection Rate (SPR) to Each Vaccine Reference Virus Post-vaccination Influenza A(H3N2)	95.8 percentage of participants Interval 89.7 to 98.4	94.7 percentage of participants Interval 88.3 to 97.7
Seroprotection Rate (SPR) to Each Vaccine Reference Virus Post-vaccination Influenza B/Victoria	81.1 percentage of participants Interval 72.0 to 87.7	76.8 percentage of participants Interval 67.4 to 84.2
Seroprotection Rate (SPR) to Each Vaccine Reference Virus Post-vaccination Influenza B/Yamagata	98.9 percentage of participants Interval 94.3 to 99.9	96.8 percentage of participants Interval 91.1 to 98.9

PRIMARY outcome

Timeframe: 6 months post-vaccination

Outcome measures

Outcome measures
Measure	FLUAD Quadrivalent n=94 Participants Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain). FLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent	FluQuadri n=96 Participants Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain). FluQuadri: 0.5 mL intramuscular dose of FluQuadri
SPR to Each Vaccine Reference Virus Post-vaccination Influenza A(H1N1)pdm09	93.6 percentage of participants Interval 86.8 to 97.0	88.5 percentage of participants Interval 80.6 to 93.5
SPR to Each Vaccine Reference Virus Post-vaccination Influenza A(H3N2)	90.4 percentage of participants Interval 82.8 to 94.9	74.0 percentage of participants Interval 64.4 to 81.7
SPR to Each Vaccine Reference Virus Post-vaccination Influenza B/Victoria	55.3 percentage of participants Interval 45.3 to 65.0	56.2 percentage of participants Interval 46.3 to 65.7
SPR to Each Vaccine Reference Virus Post-vaccination Influenza B/Yamagata	73.4 percentage of participants Interval 63.7 to 81.3	74.0 percentage of participants Interval 64.4 to 81.7

Adverse Events

FLUAD Quadrivalent

Serious events: 0 serious events

Other events: 70 other events

Deaths: 0 deaths

FluQuadri

Serious events: 0 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Perrine Marcenac

CDC

Phone: 6782830242

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	FLUAD Quadrivalent n=95 participants at risk Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain). FLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent	FluQuadri n=97 participants at risk Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain). FluQuadri: 0.5 mL intramuscular dose of FluQuadri
Gastrointestinal disorders Vomiting	1.1% 1/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	0.00% 0/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Skin and subcutaneous tissue disorders Local pain at the vaccine injection site	44.2% 42/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	33.0% 32/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
General disorders Headache	14.7% 14/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	16.5% 16/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Musculoskeletal and connective tissue disorders Muscle/articular pain	15.8% 15/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	7.2% 7/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
General disorders Malaise	12.6% 12/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	5.2% 5/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Skin and subcutaneous tissue disorders Local swelling at the vaccine injection site	7.4% 7/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	4.1% 4/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Skin and subcutaneous tissue disorders Local induration at the vaccine injection site	9.5% 9/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	1.0% 1/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Skin and subcutaneous tissue disorders Local redness at the vaccine injection site	5.3% 5/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	3.1% 3/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Skin and subcutaneous tissue disorders Local itchiness at the vaccine injection site	5.3% 5/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	1.0% 1/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Respiratory, thoracic and mediastinal disorders Sore throat	2.1% 2/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	3.1% 3/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
General disorders Measured or subjective fever	4.2% 4/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	1.0% 1/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
General disorders Nausea	2.1% 2/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	2.1% 2/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
General disorders Lack of appetite	1.1% 1/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	2.1% 2/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
General disorders Dizziness	2.1% 2/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	1.0% 1/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	3.1% 3/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Gastrointestinal disorders Loose stool	0.00% 0/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	2.1% 2/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Skin and subcutaneous tissue disorders Hematoma at the vaccine injection site	1.1% 1/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	2.1% 2/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Skin and subcutaneous tissue disorders Itchiness	0.00% 0/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	2.1% 2/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Vascular disorders Increase of systolic blood pressure	1.1% 1/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	0.00% 0/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Eye disorders Conjunctivitis	0.00% 0/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	1.0% 1/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Eye disorders Pain in left eye	1.1% 1/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	0.00% 0/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
General disorders Chills	1.1% 1/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	0.00% 0/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Respiratory, thoracic and mediastinal disorders Sneezing	1.1% 1/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	0.00% 0/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.00% 0/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	1.0% 1/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Skin and subcutaneous tissue disorders Right malar hematoma	1.1% 1/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	0.00% 0/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Respiratory, thoracic and mediastinal disorders Hyposmia	1.1% 1/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	0.00% 0/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Respiratory, thoracic and mediastinal disorders Chest tightness	0.00% 0/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	1.0% 1/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Skin and subcutaneous tissue disorders Itchiness and rash	0.00% 0/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	1.0% 1/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Skin and subcutaneous tissue disorders Itchiness and rash at vaccine injection site	1.1% 1/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	0.00% 0/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
General disorders Fatigue	0.00% 0/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	1.0% 1/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/95 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.	1.0% 1/97 • Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.