Trial Outcomes & Findings for Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly (NCT NCT03739112)

NCT ID: NCT03739112

Last Updated: 2023-06-23

Results Overview

Occurrences of laboratory-confirmed ILI caused by any influenza viral strains was measured by reverse transcriptase polymerase chain reaction (RT-PCR). A participant was considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing and at least one of the following systemic symptoms: fever (defined as a temperature \> 37.2 °C or \> 99.0 °F), chills, tiredness, headache or myalgia. The number of laboratory-confirmed ILI cases caused by any influenza strains are reported.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 12794 participants
• Primary outcome timeframe: Day 14 (post-vaccination) up to ~9 months
• Results posted on: 2023-06-23

Participant Flow

Participants were randomized in a 1:1 ratio to receive the Quadrivalent virus-like particle (VLP) Influenza Vaccine at a dose of 30 μg/strain or the active comparator.

Participants aged 65 years or older with no acute or evolving medical problems were assessed.

Participant milestones

Measure	Quadrivalent (30 μg) VLP Vaccine Participants received one intramuscular (IM) injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Overall Study STARTED	6396	6398
Overall Study Vaccinated	6365	6373
Overall Study COMPLETED	6196	6222
Overall Study NOT COMPLETED	200	176

Reasons for withdrawal

Measure	Quadrivalent (30 μg) VLP Vaccine Participants received one intramuscular (IM) injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Overall Study Adverse Event	2	2
Overall Study Withdrawal by Subject	38	19
Overall Study Lost to Follow-up	31	33
Overall Study Protocol Deviation	12	9
Overall Study Physician Decision	1	0
Overall Study Death (Classified as Withdrawn from the Study by the Investigator as a Result of Death)	12	16
Overall Study Site went on hold	65	67
Overall Study Other than specified	8	5
Overall Study Randomized but not vaccinated	31	25

Baseline Characteristics

Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly

Baseline characteristics by cohort

Measure	Quadrivalent (30 μg) VLP Vaccine n=6352 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6366 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.	Total n=12718 Participants Total of all reporting groups
Age, Continuous	72.2 years STANDARD_DEVIATION 5.67 • n=5 Participants	72.2 years STANDARD_DEVIATION 5.70 • n=7 Participants	72.2 years STANDARD_DEVIATION 5.69 • n=5 Participants
Sex: Female, Male Female	3552 Participants n=5 Participants	3561 Participants n=7 Participants	7113 Participants n=5 Participants
Sex: Female, Male Male	2800 Participants n=5 Participants	2805 Participants n=7 Participants	5605 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	202 Participants n=5 Participants	195 Participants n=7 Participants	397 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6135 Participants n=5 Participants	6161 Participants n=7 Participants	12296 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	19 Participants n=5 Participants	13 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) Asian	305 Participants n=5 Participants	299 Participants n=7 Participants	604 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Black or African American	248 Participants n=5 Participants	265 Participants n=7 Participants	513 Participants n=5 Participants
Race (NIH/OMB) White	5767 Participants n=5 Participants	5773 Participants n=7 Participants	11540 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14 (post-vaccination) up to ~9 months

Population: The Per protocol (PP) set consisted of the participants who participated in the study until at least the end of the peak period or for at least five months or until the end of the surveillance period.

Occurrences of laboratory-confirmed ILI caused by any influenza viral strains was measured by reverse transcriptase polymerase chain reaction (RT-PCR). A participant was considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing and at least one of the following systemic symptoms: fever (defined as a temperature > 37.2 °C or > 99.0 °F), chills, tiredness, headache or myalgia. The number of laboratory-confirmed ILI cases caused by any influenza strains are reported.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=5996 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6026 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Occurrences of Protocol-Defined Influenza-Like Illness (ILI) Due to Any Laboratory-Confirmed Influenza Strains	118 Number of cases	130 Number of cases

SECONDARY outcome

Timeframe: Day 14 (post-vaccination) up to ~9 months

Population: PP set.

Occurrences of protocol-defined ILI due to laboratory-confirmed influenza caused by influenza viral types/subtypes that were matched (and/or antigenically similar) to the strains covered in the vaccine formulation was measured by sequential RT-PCR & serotyping. The vaccine-matched strains included: homologous A/Michigan/45/2015 [H1N1], homologous A/Singapore/INFIMH-16-0019/2016 [H3N2], homologous B/Colorado/06/2017 and homologous B/Phuket/3073/2013) covered in the vaccine formulation. A participant was considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing and at least one of the following systemic symptoms: fever (defined as a temperature > 37.2 °C or > 99.0 °F), chills, tiredness, headache or myalgia. The number of laboratory-confirmed ILI cases caused by vaccine-matched influenza strains (all matched strains) are reported.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=5996 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6026 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Occurrences of Laboratory Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Vaccine-Matched Influenza Strains	42 Number of cases	46 Number of cases

SECONDARY outcome

Timeframe: Day 14 (post-vaccination) up to ~9 months

Population: PP set.

Occurrences of protocol-defined respiratory illness due to laboratory-confirmed influenza strain (matched, mismatched, and un-typed) was measured by sequential RT-PCR. A protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing. The number of protocol-defined respiratory illness cases caused by any laboratory-confirmed influenza strain (matched, mismatched, and un-typed) are reported.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=5996 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6026 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Occurrences of Protocol-Defined Respiratory Illness Due to Any Laboratory-Confirmed Influenza Strains	148 Number of cases	167 Number of cases

SECONDARY outcome

Timeframe: Day 14 (post-vaccination) up to ~9 months

Population: PP set.

Occurrences of protocol-defined respiratory illness vaccine caused by vaccine-matched influenza strains was measured by sequential RT-PCR & serotyping. The vaccine-matched strains included: homologous A/Michigan/45/2015 [H1N1], homologous A/Singapore/INFIMH-16-0019/2016 [H3N2], homologous B/Colorado/06/2017 and homologous B/Phuket/3073/2013. The protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing. The number of protocol-defined respiratory illness cases caused by one or more vaccine-matched strains are reported.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=5996 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6026 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Occurrences of Protocol-Defined Respiratory Illness Vaccine Caused by Vaccine-Matched Influenza Strains	50 Number of cases	55 Number of cases

SECONDARY outcome

Timeframe: Day 14 (post-vaccination) up to ~9 months

Population: PP set.

Occurrences of protocol-defined ILI that were confirmed or not by laboratory testing were assessed. A participant was considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing and at least one of the following systemic symptoms: fever (defined as a temperature > 37.2 °C or > 99.0 °F), chills, tiredness, headache or myalgia. The number of protocol-defined ILI cases (confirmed or not) are reported.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=5996 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6026 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Occurrences of Protocol-Defined ILI	1249 Number of cases	1243 Number of cases

SECONDARY outcome

Timeframe: 15 minutes post vaccination

Population: SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Immediate complaints were defined as any solicited local or systemic reactions. Solicited local reactions included: erythema, swelling, and pain at the injection site) and solicited systemic reactions included: fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=6352 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6366 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Participants With at Least One Immediate Complaints	272 Participants	184 Participants

SECONDARY outcome

Timeframe: Day 0 (post-vaccination) to Day 7

Population: SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck) from the time of vaccination through Day 7. Any solicited local or systemic immediate complaint was also included.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=6352 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6366 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Participants With at Least One Solicited Local and Systemic Reactions Solicited Local Reactions	1954 Participants	1460 Participants
Number of Participants With at Least One Solicited Local and Systemic Reactions Solicited Systemic Reactions	1682 Participants	1497 Participants

SECONDARY outcome

Timeframe: Day 0 (post-vaccination) to Day 7

Population: SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). The intensity of the solicited reactions was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the Food and Drug Administration (FDA) Guidance for Industry. ≥ Severe events included severe and potentially life-threatening events. Any ≥severe solicited reactions are reported.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=6352 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6366 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Participants With ≥ Severe Solicited Local and Systemic Reaction	47 Participants	62 Participants

SECONDARY outcome

Timeframe: Day 0 (post-vaccination) to Day 7

Population: SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Participants were monitored for both solicited local reactions (erythema, swelling, & pain at the injection site) & solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in axilla, & swelling in neck). The intensity of solicited reactions was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the FDA Guidance for Industry. ≥ Severe events included severe and potentially life-threatening events. Any ≥severe related (possibly related, probably related, and definitely related to the study treatments [as defined by investigator]) solicited events are reported.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=6352 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6366 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Participants With ≥ Severe Related Solicited Reactions	28 Participants	51 Participants

SECONDARY outcome

Timeframe: Day 0 (post-vaccination) to Day 21

Population: SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Participants were monitored for unsolicited TEAEs (e.g., nasopharyngitis, upper respiratory tract infection, headache, and pain). An adverse event (AE) or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who received study drug, with or without a causal relationship with the treatment. An AE was considered treatment-emergent if it began on or after the date and time of Study Day 0 vaccination.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=6352 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6366 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Participants With Unsolicited Treatment-Emergent Adverse Events (TEAEs)	849 Participants	824 Participants

SECONDARY outcome

Timeframe: Day 0 (post-vaccination) to Day 21

Population: SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Participants were monitored for unsolicited TEAEs (e.g., nasopharyngitis, upper respiratory tract infection, headache, and pain). AE: any untoward medical occurrence in a participant or clinical investigation participant who received study drug, with or without a causal relationship with the treatment. An AE was considered treatment-emergent if it began on or after the date and time of Study Day 0 vaccination. The intensity of the solicited reactions was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the FDA Guidance for Industry. ≥ severe events included severe and potentially life-threatening events. Any ≥ severe unsolicited reactions are reported.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=6352 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6366 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Participants With ≥ Severe Unsolicited TEAEs	33 Participants	34 Participants

SECONDARY outcome

Timeframe: Day 0 (post-vaccination) to Day 21

Population: SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Participants were monitored for unsolicited TEAEs (e.g., nasopharyngitis, upper respiratory tract infection, headache, & pain). AE: any untoward medical occurrence in a participant who received study drug, with or without a causal relationship with treatment. An AE was considered treatment-emergent if it began on or after date & time of Study Day 0 vaccination. Intensity of solicited reactions was graded as mild (1) easily tolerated & not interfere with usual activity; moderate (2) interferes with daily activity, but participant still able to function; severe (3) incapacitating & participant unable to work/complete usual activity/ potentially life threatening; (4) likely to be life-threatening if not treated in a timely manner, according to FDA Guidance for Industry. ≥ severe events included severe & potentially life-threatening events. Any ≥severe related (possibly, probably, & definitely related to study treatments [as defined by investigator]) unsolicited events are reported.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=6352 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6366 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Participants With ≥ Severe Related Unsolicited Reactions	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 0 to ~9 months

Population: SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

An AE was any untoward medical occurrence in a participant who received study drug, with or without a causal relationship with treatment. An SAE was an AE that resulted in death, was life threatening, resulted in a persistent or significant disability or incapacity, resulted in or prolonged an existing hospitalization, was a congenital anomaly or birth defect, or was another important medical event.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=6352 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6366 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Participants With at Least One Serious Adverse Event (SAE)	263 Participants	266 Participants

SECONDARY outcome

Timeframe: Day 0 up to ~9 months

Population: SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

The number of participants who died during the study was assessed.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=6352 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6366 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Occurrences of Death	12 Participants	17 Participants

SECONDARY outcome

Timeframe: Day 0 up to ~9 months

Population: SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

An AE or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who received study drug, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=6352 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6366 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Participants Who Withdrew Due to an AE	15 Participants	20 Participants

SECONDARY outcome

Timeframe: Day 0 up to ~9 months

Population: SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were reported. Plausibility should be interpreted broadly however; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions and kidney diseases should be reported. NOCDs were collected from vaccination on Day 0 to the end of the surveillance period.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=6352 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6366 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Number of Participants With at Least One New Onset Chronic Diseases (NOCDs)	36 Participants	23 Participants

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 21

Population: The Immunogenicity Per Protocol (IPP) set consisted of a subset of participants who participated in the immunogenicity portion of the study and who had a Day 21 immunogenicity sample collection.

GMTs were measured using a HI assay for the homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013, and the heterologous strains: H1N1 = A/Brisbane/59/2007; H3N2 = A/Uruguay/716/2007; B/Malaysia = B/Malaysia/2506/2004; B/Florida = B/Florida/4/2006.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=206 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=199 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Homologous Strain (B/Phuket): Day 21	45.0 Titers Interval 37.8 to 53.5	75.5 Titers Interval 63.3 to 90.1
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Heterologous Strain (B/Malaysia): Day 21	15.9 Titers Interval 13.6 to 18.7	34.8 Titers Interval 29.5 to 41.0
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Heterologous Strain (B/Florida): Day 21	38.0 Titers Interval 32.2 to 44.8	72.1 Titers Interval 61.0 to 85.2
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Homologous Strain (H1N1): Day 0	43.8 Titers Interval 36.3 to 52.7	36.3 Titers Interval 30.0 to 43.9
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Homologous Strain (H1N1): Day 21	88.9 Titers Interval 73.7 to 107.2	146.8 Titers Interval 121.4 to 177.7
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Homologous Strain (H3N2): Day 0	31.1 Titers Interval 25.5 to 37.8	30.9 Titers Interval 25.3 to 37.8
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Homologous Strain (H3N2): Day 21	79.5 Titers Interval 65.2 to 97.1	90.2 Titers Interval 73.7 to 110.5
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Homologous Strain (B/Colorado): Day 0	15.5 Titers Interval 13.3 to 18.1	13.2 Titers Interval 11.3 to 15.5
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Homologous Strain (B/Colorado): Day 21	23.0 Titers Interval 19.3 to 27.4	51.7 Titers Interval 43.3 to 61.8
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Homologous Strain (B/Phuket): Day 0	24.4 Titers Interval 20.8 to 28.7	22.6 Titers Interval 19.2 to 26.6
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Heterologous Strain (H1N1): Day 0	15.5 Titers Interval 13.6 to 17.6	13.5 Titers Interval 11.8 to 15.4
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Heterologous Strain (H1N1): Day 21	16.6 Titers Interval 14.3 to 19.2	32.4 Titers Interval 28.0 to 37.6
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Heterologous Strain (H3N2): Day 0	19.5 Titers Interval 16.4 to 23.3	22.6 Titers Interval 18.9 to 27.1
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Heterologous Strain (H3N2): Day 21	32.4 Titers Interval 27.1 to 38.6	46.6 Titers Interval 38.9 to 55.8
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Heterologous Strain (B/Malaysia): Day 0	12.6 Titers Interval 11.0 to 14.5	11.4 Titers Interval 10.0 to 13.1
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain Heterologous Strain (B/Florida): Day 0	22.5 Titers Interval 19.2 to 26.4	20.6 Titers Interval 17.5 to 24.2

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) to Day 21

Population: IPP set.

The percentage of participants in a given treatment group with either a ≥ 4-fold increase in reciprocal HI titers between Day 0 and Day 21 or a rise of undetectable HI titer (i.e. < 10) pre-vaccination (Day 0) to an HI titer of ≥ 40 on Day 21 was measured using an HI assay for the homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013, and the heterologous strains: H1N1 = A/Brisbane/59/2007; H3N2 = A/Uruguay/716/2007; B/Malaysia = B/Malaysia/2506/2004; B/Florida = B/Florida/4/2006.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=206 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=199 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (H1N1)	15.5 percentage of participants Interval 10.9 to 21.2	40.7 percentage of participants Interval 33.8 to 47.9
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (H3N2)	25.2 percentage of participants Interval 19.5 to 31.7	28.1 percentage of participants Interval 22.0 to 34.9
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (B/Colorado)	10.2 percentage of participants Interval 6.4 to 15.2	38.2 percentage of participants Interval 31.4 to 45.3
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (B/Phuket)	16.5 percentage of participants Interval 11.7 to 22.3	34.7 percentage of participants Interval 28.1 to 41.7
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (H1N1)	0.5 percentage of participants Interval 0.0 to 2.7	24.1 percentage of participants Interval 18.4 to 30.7
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (H3N2)	10.7 percentage of participants Interval 6.8 to 15.7	14.6 percentage of participants Interval 10.0 to 20.3
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (B/Malaysia)	5.3 percentage of participants Interval 2.7 to 9.4	30.7 percentage of participants Interval 24.3 to 37.6
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (B/Florida)	12.1 percentage of participants Interval 8.0 to 17.4	37.7 percentage of participants Interval 30.9 to 44.8

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 21

Population: IPP set.

The percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥ 40 on Day 21 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) was measured using an HI assay for homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013, and the heterologous strains: H1N1 = A/Brisbane/59/2007; H3N2 = A/Uruguay/716/2007; B/Malaysia = B/Malaysia/2506/2004; B/Florida = B/Florida/4/2006.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=206 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=199 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (H1N1): Day 21	77.2 percentage of participants Interval 70.8 to 82.7	87.9 percentage of participants Interval 82.6 to 92.1
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (B/Phuket): Day 21	64.1 percentage of participants Interval 57.1 to 70.6	79.4 percentage of participants Interval 73.1 to 84.8
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (H3N2): Day 21	50.0 percentage of participants Interval 43.0 to 57.0	63.8 percentage of participants Interval 56.7 to 70.5
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (B/Florida): Day 21	58.7 percentage of participants Interval 51.7 to 65.5	76.9 percentage of participants Interval 70.4 to 82.6
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (H1N1): Day 0	57.3 percentage of participants Interval 50.2 to 64.1	52.8 percentage of participants Interval 45.6 to 59.9
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (H3N2): Day 0	48.5 percentage of participants Interval 41.5 to 55.6	52.8 percentage of participants Interval 45.6 to 59.9
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (H3N2): Day 21	72.3 percentage of participants Interval 65.7 to 78.3	78.4 percentage of participants Interval 72.0 to 83.9
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (B/Colorado): Day 0	28.6 percentage of participants Interval 22.6 to 35.3	22.1 percentage of participants Interval 16.5 to 28.5
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (B/Colorado): Day 21	40.3 percentage of participants Interval 33.5 to 47.3	62.3 percentage of participants Interval 55.2 to 69.1
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (B/Phuket): Day 0	46.6 percentage of participants Interval 39.6 to 53.7	38.7 percentage of participants Interval 31.9 to 45.8
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (H1N1): Day 0	21.8 percentage of participants Interval 16.4 to 28.1	18.1 percentage of participants Interval 13.0 to 24.2
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (H1N1): Day 21	22.8 percentage of participants Interval 17.3 to 29.2	49.2 percentage of participants Interval 42.1 to 56.4
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (H3N2): Day 0	35.4 percentage of participants Interval 28.9 to 42.4	40.2 percentage of participants Interval 33.3 to 47.4
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (B/Malaysia): Day 0	22.8 percentage of participants Interval 17.3 to 29.2	17.6 percentage of participants Interval 12.6 to 23.6
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (B/Malaysia): Day 21	30.1 percentage of participants Interval 23.9 to 36.9	53.8 percentage of participants Interval 46.6 to 60.8
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (B/Florida): Day 0	37.4 percentage of participants Interval 30.8 to 44.4	31.2 percentage of participants Interval 24.8 to 38.1

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 21

Population: IPP set.

GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0), was measured using an HI assay homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013, and the heterologous strains: H1N1 = A/Brisbane/59/2007; H3N2 = A/Uruguay/716/2007; B/Malaysia = B/Malaysia/2506/2004; B/Florida = B/Florida/4/2006.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=206 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=199 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Geometric Mean Fold Rise (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (H1N1)	1.1 Ratio Interval 1.0 to 1.2	2.4 Ratio Interval 2.2 to 2.6
Geometric Mean Fold Rise (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (H3N2)	1.6 Ratio Interval 1.5 to 1.8	2.1 Ratio Interval 1.9 to 2.3
Geometric Mean Fold Rise (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (B/Florida)	1.7 Ratio Interval 1.5 to 1.9	3.4 Ratio Interval 3.0 to 3.9
Geometric Mean Fold Rise (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (H1N1)	2.1 Ratio Interval 1.8 to 2.4	3.9 Ratio Interval 3.4 to 4.5
Geometric Mean Fold Rise (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (H3N2)	2.6 Ratio Interval 2.2 to 3.0	2.9 Ratio Interval 2.5 to 3.4
Geometric Mean Fold Rise (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (B/Colorado)	1.5 Ratio Interval 1.3 to 1.8	3.8 Ratio Interval 3.3 to 4.4
Geometric Mean Fold Rise (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain Homologous Strain (B/Phuket)	1.9 Ratio Interval 1.6 to 2.1	3.3 Ratio Interval 2.9 to 3.8
Geometric Mean Fold Rise (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain Heterologous Strain (B/Malaysia)	1.3 Ratio Interval 1.1 to 1.4	3.0 Ratio Interval 2.7 to 3.4

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 21

Population: IPP set.

GMTs were measured using an MN assay for homologous strains:H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=206 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=199 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain H3N2: Day 0	227.4 Titers Interval 194.9 to 265.3	240.1 Titers Interval 205.3 to 280.8
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain H3N2: Day 21	558.5 Titers Interval 461.2 to 676.3	437.0 Titers Interval 359.7 to 531.0
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain B/Colorado: Day 21	124.1 Titers Interval 105.4 to 146.2	193.1 Titers Interval 163.5 to 228.1
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain H1N1: Day 0	501.4 Titers Interval 420.6 to 597.8	511.2 Titers Interval 427.5 to 611.3
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain H1N1: Day 21	1120.7 Titers Interval 926.3 to 1355.9	1807.0 Titers Interval 1488.6 to 2193.6
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain B/Colorado: Day 0	62.7 Titers Interval 54.1 to 72.6	55.1 Titers Interval 47.5 to 64.0
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain B/Phuket: Day 0	50.5 Titers Interval 44.4 to 57.6	45.8 Titers Interval 40.1 to 52.3
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain B/Phuket: Day 21	98.2 Titers Interval 85.7 to 112.6	143.4 Titers Interval 124.8 to 164.7

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) to Day 21

Population: IPP set.

The percentage of participants in a given treatment group with either a ≥ 4-fold increase in reciprocal MN titers between Day 0 and Day 21 or a rise of undetectable MN titer (i.e. 7.1) pre-vaccination (Day 0) to an MN titer of ≥ 28.3 at Day 21 post-vaccination were measured using an MN assay for homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=206 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=199 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Strain H1N1	25.7 percentage of participants Interval 19.9 to 32.3	43.2 percentage of participants Interval 36.2 to 50.4
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Strain H3N2	36.4 percentage of participants Interval 29.8 to 43.4	26.6 percentage of participants Interval 20.6 to 33.3
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Strain B/Colorado	19.9 percentage of participants Interval 14.7 to 26.0	43.7 percentage of participants Interval 36.7 to 50.9
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Strain B/Phuket	19.4 percentage of participants Interval 14.2 to 25.5	41.2 percentage of participants Interval 34.3 to 48.4

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 21

Population: IPP set.

GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0), was measured using an MN assay for H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=206 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=199 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
GMFR of MN Antibody Response for Each Homologous Strain H1N1	2.2 Ratio Interval 1.9 to 2.6	3.5 Ratio Interval 3.0 to 4.1
GMFR of MN Antibody Response for Each Homologous Strain H3N2	2.4 Ratio Interval 2.1 to 2.8	1.8 Ratio Interval 1.6 to 2.1
GMFR of MN Antibody Response for Each Homologous Strain B/Colorado	2.0 Ratio Interval 1.8 to 2.3	3.4 Ratio Interval 3.0 to 3.9
GMFR of MN Antibody Response for Each Homologous Strain B/Phuket	2.0 Ratio Interval 1.8 to 2.2	3.1 Ratio Interval 2.8 to 3.4

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 21

Population: IPP set.

GMA was measured using an SRH assay for homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=206 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=199 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Geometric Mean Areas (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain H1N1: Day 21	38.7 mm^2 Interval 34.7 to 43.1	48.9 mm^2 Interval 43.8 to 54.6
Geometric Mean Areas (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain H3N2: Day 0	6.3 mm^2 Interval 5.1 to 7.9	5.1 mm^2 Interval 4.1 to 6.3
Geometric Mean Areas (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain H1N1: Day 0	23.8 mm^2 Interval 20.4 to 27.7	20.7 mm^2 Interval 17.7 to 24.2
Geometric Mean Areas (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain H3N2: Day 21	21.9 mm^2 Interval 17.2 to 28.0	13.2 mm^2 Interval 10.3 to 17.0
Geometric Mean Areas (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain B/Colorado: Day 0	33.7 mm^2 Interval 28.1 to 40.3	29.2 mm^2 Interval 24.3 to 35.1
Geometric Mean Areas (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain B/Colorado: Day 21	54.1 mm^2 Interval 47.3 to 61.8	61.0 mm^2 Interval 53.3 to 69.9
Geometric Mean Areas (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain B/Phuket: Day 0	21.5 mm^2 Interval 17.7 to 26.0	20.4 mm^2 Interval 16.8 to 24.8
Geometric Mean Areas (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain B/Phuket: Day 21	38.8 mm^2 Interval 33.5 to 44.9	50.2 mm^2 Interval 43.3 to 58.3

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) to Day 21

Population: IPP set.

The percentage of participants in a given treatment group showing at least 50 % increase in GMA between Days 0 and 21 were measured using an SRH assay for homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=206 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=199 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Percentage of Participants With Seroconversion Measured by SRH Antibody Response for Each Homologous Strain B/Phuket	35.9 percentage of participants Interval 29.4 to 42.9	52.3 percentage of participants Interval 45.1 to 59.4
Percentage of Participants With Seroconversion Measured by SRH Antibody Response for Each Homologous Strain H1N1	34.0 percentage of participants Interval 27.5 to 40.9	55.3 percentage of participants Interval 48.1 to 62.3
Percentage of Participants With Seroconversion Measured by SRH Antibody Response for Each Homologous Strain H3N2	45.1 percentage of participants Interval 38.2 to 52.2	34.7 percentage of participants Interval 28.1 to 41.7
Percentage of Participants With Seroconversion Measured by SRH Antibody Response for Each Homologous Strain B/Colorado	32.0 percentage of participants Interval 25.7 to 38.9	49.7 percentage of participants Interval 42.6 to 56.9

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 21

Population: IPP set.

The percentage of participants in a given treatment group attaining an area ≥ 25 mm^2 following vaccination (Day 21) were measured using an SRH assay for homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=206 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=199 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain H3N2: Day 21	63.6 percentage of participants Interval 56.6 to 70.2	51.8 percentage of participants Interval 44.6 to 58.9
Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain B/Phuket: Day 0	63.6 percentage of participants Interval 56.6 to 70.2	60.8 percentage of participants Interval 53.7 to 67.6
Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain H1N1: Day 0	56.8 percentage of participants Interval 49.7 to 63.7	51.8 percentage of participants Interval 44.6 to 58.9
Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain H1N1: Day 21	77.7 percentage of participants Interval 71.4 to 83.2	89.4 percentage of participants Interval 84.3 to 93.3
Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain H3N2: Day 0	27.7 percentage of participants Interval 21.7 to 34.3	23.6 percentage of participants Interval 17.9 to 30.1
Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain B/Colorado: Day 0	71.8 percentage of participants Interval 65.2 to 77.9	69.8 percentage of participants Interval 63.0 to 76.1
Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain B/Colorado: Day 21	87.9 percentage of participants Interval 82.6 to 92.0	89.4 percentage of participants Interval 84.3 to 93.3
Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain B/Phuket: Day 21	76.2 percentage of participants Interval 69.8 to 81.9	87.9 percentage of participants Interval 82.6 to 92.1

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 21

Population: IPP set.

GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0), was measured using an SRH assay for homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013.

Outcome measures

Measure	Quadrivalent (30 μg) VLP Vaccine n=206 Participants Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=199 Participants Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
GMFR of SRH Antibody Response for Each Homologous Strain H1N1	1.7 Ratio Interval 1.6 to 1.8	2.3 Ratio Interval 2.1 to 2.5
GMFR of SRH Antibody Response for Each Homologous Strain H3N2	3.6 Ratio Interval 2.9 to 4.4	2.5 Ratio Interval 2.0 to 3.1
GMFR of SRH Antibody Response for Each Homologous Strain B/Colorado	1.7 Ratio Interval 1.5 to 1.9	2.0 Ratio Interval 1.8 to 2.2
GMFR of SRH Antibody Response for Each Homologous Strain B/Phuket	1.8 Ratio Interval 1.6 to 2.1	2.4 Ratio Interval 2.2 to 2.7

Adverse Events

Quadrivalent (30 μg) VLP Vaccine

Serious events: 263 serious events

Other events: 935 other events

Deaths: 12 deaths

Active Comparator (Fluarix)

Serious events: 266 serious events

Other events: 908 other events

Deaths: 17 deaths

Serious adverse events

Measure	Quadrivalent (30 μg) VLP Vaccine n=6352 participants at risk Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6366 participants at risk Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
Infections and infestations Abscess	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Appendicitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Appendicitis perforated	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Bronchitis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.06% 4/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Bursitis infective	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Cellulitis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Diverticulitis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Empyema	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Endocarditis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Erysipelas	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Gastroenteritis	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Gastroenteritis Escherichia coli	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Gastroenteritis viral	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations H1N1 influenza	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Herpes zoster	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Influenza	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.06% 4/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Localised infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Necrotising fasciitis staphylococcal	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Orchitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Osteomyelitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Osteomyelitis bacterial	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Pharyngeal abscess	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Pneumonia	0.31% 20/6352 • Number of events 20 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.17% 11/6366 • Number of events 12 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Pneumonia legionella	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Pneumonia viral	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Postoperative wound infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Pseudomonal sepsis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Pyelonephritis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Respiratory syncytial virus infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Sepsis	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Sialoadenitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Sinusitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Staphylococcal infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Streptococcal bacteraemia	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Urinary tract infection	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Urosepsis	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acral lentiginous melanoma	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Biliary neoplasm	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial neoplasm	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage I	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Female reproductive neoplasm	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary mucinous neoplasm	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage III	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoplasmacytoid lymphoma/immunocytoma recurrent	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage II	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.09% 6/6366 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer recurrent	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Triple negative breast cancer	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Waldenstrom's macroglobulinaemia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Blood and lymphatic system disorders Anaemia	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Blood and lymphatic system disorders Microcytic anaemia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Blood and lymphatic system disorders Splenic haematoma	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Immune system disorders Anaphylactic reaction	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Immune system disorders Drug hypersensitivity	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Endocrine disorders Goitre	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Dehydration	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Gout	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Hyperkalaemia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Hypokalaemia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Hyponatraemia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Hypovolaemia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Anxiety	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Chronic idiopathic pain syndrome	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Completed suicide	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Confusional state	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Delirium	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Disorientation	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Mental status changes	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Mood disorder due to a general medical condition	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Suicidal ideation	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Carotid artery stenosis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Cerebellar stroke	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Cerebral haemorrhage	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Cerebral infarction	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Cerebrovascular accident	0.11% 7/6352 • Number of events 7 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.14% 9/6366 • Number of events 9 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Chronic inflammatory demyelinating polyradiculoneuropathy	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Dementia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Dementia Alzheimer's type	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Diabetic neuropathy	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Dizziness	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Hepatic encephalopathy	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Hydrocephalus	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders IVth nerve paralysis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Ischaemic stroke	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Loss of consciousness	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Neuropathy peripheral	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Parkinson's disease	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Parkinsonism	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Presyncope	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Sciatica	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Seizure	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Spondylitic myelopathy	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Syncope	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Transient global amnesia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Transient ischaemic attack	0.09% 6/6352 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Vertebrobasilar insufficiency	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Amaurosis fugax	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Corneal degeneration	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Dacryostenosis acquired	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Ear and labyrinth disorders Deafness	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Ear and labyrinth disorders Vertigo	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Ear and labyrinth disorders Vertigo positional	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Ear and labyrinth disorders Vestibular disorder	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Acute coronary syndrome	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Acute myocardial infarction	0.09% 6/6352 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.13% 8/6366 • Number of events 8 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Angina pectoris	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Angina unstable	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Arrhythmia	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Atrial fibrillation	0.17% 11/6352 • Number of events 12 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.19% 12/6366 • Number of events 13 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Atrial flutter	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Bradycardia	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Cardiac arrest	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Cardiac failure	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Cardiac failure chronic	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Cardiac failure congestive	0.08% 5/6352 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Coronary artery disease	0.08% 5/6352 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Coronary artery occlusion	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Myocardial infarction	0.08% 5/6352 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Pericardial effusion	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Pericarditis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Pulseless electrical activity	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Sinus arrest	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Sinus bradycardia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Sinus node dysfunction	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Tachyarrhythmia	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Accelerated hypertension	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Angiodysplasia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Aortic aneurysm	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Aortic dissection	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Aortic stenosis	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Circulatory collapse	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Deep vein thrombosis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Extremity necrosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Hypertension	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Hypertensive crisis	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Hypertensive emergency	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Hypotension	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Orthostatic hypotension	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Peripheral arterial occlusive disease	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Peripheral vascular disorder	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Varicose vein	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Asthma	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.08% 5/6352 • Number of events 7 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.09% 6/6366 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Emphysema	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.09% 6/6366 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.02% 1/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Colitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Diverticulum	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Duodenal ulcer	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Gastric haemorrhage	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Gastric ulcer	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Gastric ulcer perforation	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Gastritis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Hiatus hernia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Ileus	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Incarcerated inguinal hernia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Inguinal hernia	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Mesenteric arterial occlusion	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Pancreatitis	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Portal hypertensive gastropathy	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Proctitis ulcerative	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Reactive gastropathy	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Rectal haemorrhage	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Small intestinal obstruction	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Subileus	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Bile duct stenosis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Bile duct stone	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Cholecystitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Cholecystitis chronic	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Cholelithiasis	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Cholestasis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Sphincter of Oddi dysfunction	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Arthralgia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Back pain	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Camptocormia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Lateral patellar compression syndrome	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.14% 9/6352 • Number of events 9 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.14% 9/6366 • Number of events 9 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Synovial cyst	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Systemic scleroderma	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Acute kidney injury	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Bladder prolapse	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Glomerulonephritis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Haematuria	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Nephrolithiasis	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Renal colic	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Renal failure	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Ureterolithiasis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Urinary incontinence	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Reproductive system and breast disorders Endometriosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Reproductive system and breast disorders Rectocele	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Reproductive system and breast disorders Uterine polyp	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Reproductive system and breast disorders Uterine prolapse	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Reproductive system and breast disorders Uterovaginal prolapse	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Reproductive system and breast disorders Vaginal haemorrhage	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Reproductive system and breast disorders Vaginal prolapse	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Reproductive system and breast disorders Varicocele	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Congenital, familial and genetic disorders Arteriovenous malformation	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Congenital, familial and genetic disorders Hamartoma	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Congenital, familial and genetic disorders Syringomyelia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Chest pain	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.06% 4/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Death	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Incarcerated hernia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Malaise	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Non-cardiac chest pain	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Pain	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Pyrexia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Surgical failure	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Vascular stent stenosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Investigations Fibrin D dimer increased	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Animal attack	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Ankle fracture	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.06% 4/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Concussion	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Contusion	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Fall	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Fascial rupture	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Femur fracture	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Foreign body aspiration	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Fractured coccyx	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Head injury	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Hip fracture	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Lacrimal structure injury	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Limb injury	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Meniscus injury	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Pelvic fracture	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Postoperative ileus	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Radius fracture	0.02% 1/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Rib fracture	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Road traffic accident	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Spinal fracture	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Subdural haematoma	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Tendon rupture	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Tibia fracture	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Upper limb fracture	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Urinary retention postoperative	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Wrist fracture	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Surgical and medical procedures Atrial appendage closure	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Product Issues Device dislocation	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Coronary artery stenosis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Other adverse events

Measure	Quadrivalent (30 μg) VLP Vaccine n=6352 participants at risk Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Active Comparator (Fluarix) n=6366 participants at risk Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.
General disorders Feeling hot	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Gait disturbance	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Chest discomfort	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Chest pain	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Asthenia	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Axillary pain	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Chills	0.24% 15/6352 • Number of events 15 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.24% 15/6366 • Number of events 15 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Discomfort	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Face oedema	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Facial pain	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Fatigue	0.41% 26/6352 • Number of events 27 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.50% 32/6366 • Number of events 35 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Acute sinusitis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Adenovirus infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Borrelia infection	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Bronchitis	0.19% 12/6352 • Number of events 12 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.13% 8/6366 • Number of events 8 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Cellulitis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Conjunctivitis	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Cystitis	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.09% 6/6366 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Cystitis escherichia	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Diverticulitis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Ear infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Erysipelas	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Eye infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Eye infection bacterial	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Folliculitis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Gastroenteritis	0.09% 6/6352 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.13% 8/6366 • Number of events 8 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Gastroenteritis viral	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Gastrointestinal infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Gastrointestinal viral infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Genital infection fungal	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Gingivitis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Haemorrhagic fever with renal syndrome	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Helicobacter infection	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Hepatitis C	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Herpes simplex	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Herpes zoster	0.08% 5/6352 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Hordeolum	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Infected bite	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Influenza	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.20% 13/6366 • Number of events 14 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Laryngitis	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Localised infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Lower respiratory tract infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Nasal herpes	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Nasopharyngitis	1.4% 88/6352 • Number of events 88 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	1.2% 76/6366 • Number of events 77 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Onychomycosis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Oral candidiasis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Oral herpes	0.08% 5/6352 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Otitis media	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Periodontitis	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Pertussis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Pharyngitis	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Pilonidal cyst	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Pneumonia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.06% 4/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Respiratory tract infection	0.13% 8/6352 • Number of events 8 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Respiratory tract infection viral	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Rhinitis	0.14% 9/6352 • Number of events 9 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.09% 6/6366 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Root canal infection	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Sinusitis	0.20% 13/6352 • Number of events 13 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.14% 9/6366 • Number of events 9 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Sinusitis bacterial	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Streptococcal infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Tinea infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Tooth abscess	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Tooth infection	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Upper respiratory tract infection	0.82% 52/6352 • Number of events 53 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.74% 47/6366 • Number of events 48 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Urinary tract infection	0.24% 15/6352 • Number of events 15 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.20% 13/6366 • Number of events 13 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Vaginal infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Varicella zoster virus infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Viral infection	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Infections and infestations Wound infection	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Eye naevus	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.02% 1/6352 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Blood and lymphatic system disorders Anaemia	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Blood and lymphatic system disorders Iron deficiency anaemia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Blood and lymphatic system disorders Lymph node pain	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Blood and lymphatic system disorders Lymphadenopathy	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Immune system disorders Drug hypersensitivity	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Immune system disorders Seasonal allergy	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Endocrine disorders Goitre	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Endocrine disorders Hyperthyroidism	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Endocrine disorders Hypothyroidism	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.06% 4/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Dehydration	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Dyslipidaemia	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Glucose tolerance impaired	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Gout	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Hypercholesterolaemia	0.13% 8/6352 • Number of events 8 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Hyperglycaemia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Hyperlipidaemia	0.08% 5/6352 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Hypokalaemia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Iron deficiency	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Ketoacidosis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Lactose intolerance	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Lipid metabolism disorder	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.13% 8/6366 • Number of events 8 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Metabolism and nutrition disorders Vitamin D deficiency	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Abnormal dreams	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Aggression	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Anxiety	0.08% 5/6352 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Confusional state	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Depression	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Fear	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Initial insomnia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Insomnia	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Listless	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Nervousness	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Restlessness	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Psychiatric disorders Sleep disorder	0.03% 2/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Carotid artery stenosis	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Carpal tunnel syndrome	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Cerebral atrophy	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Cerebral microangiopathy	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Complex regional pain syndrome	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Dementia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Dementia Alzheimer's type	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Dizziness	0.30% 19/6352 • Number of events 20 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.38% 24/6366 • Number of events 25 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Dysgeusia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Facial paralysis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Head discomfort	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Headache	0.96% 61/6352 • Number of events 73 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	1.0% 66/6366 • Number of events 71 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Hypoaesthesia	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Hypogeusia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Memory impairment	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Migraine	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Movement disorder	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Myasthenia gravis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Neuralgia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Neuropathy peripheral	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Paraesthesia	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Parkinson's disease	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Polyneuropathy	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Posterior cortical atrophy	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Presyncope	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Radiculopathy	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Restless legs syndrome	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Sciatica	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Sinus headache	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Somnolence	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Syncope	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Tension headache	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Trigeminal neuralgia	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders VIth nerve paralysis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders Visual field defect	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Nervous system disorders White matter lesion	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Astigmatism	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Binocular eye movement disorder	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Blepharitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Blepharochalasis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Blindness transient	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Cataract	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Chalazion	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Conjunctival haemorrhage	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Corneal warpage	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Dry age-related macular degeneration	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Dry eye	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Eye discharge	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Eye haemorrhage	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Eye inflammation	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Eye irritation	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Eye pain	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Eye pruritus	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Eye swelling	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Eyelid irritation	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Eyelid margin crusting	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Eyelid oedema	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Eyelid pain	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Glaucoma	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Hyalosis asteroid	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Keratitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Lacrimation increased	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Macular degeneration	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Macular fibrosis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Neovascular age-related macular degeneration	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Ocular hyperaemia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Ocular rosacea	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Vision blurred	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Visual impairment	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Eye disorders Vitreous haemorrhage	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Ear and labyrinth disorders Cerumen impaction	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Ear and labyrinth disorders Ear discomfort	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Ear and labyrinth disorders Ear pain	0.11% 7/6352 • Number of events 7 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.11% 7/6366 • Number of events 7 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Ear and labyrinth disorders Tinnitus	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Ear and labyrinth disorders Vertigo	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.06% 4/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Ear and labyrinth disorders Vertigo positional	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Acute left ventricular failure	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Angina pectoris	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Aortic valve incompetence	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Aortic valve stenosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Arrhythmia	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Atrial fibrillation	0.17% 11/6352 • Number of events 11 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.17% 11/6366 • Number of events 11 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Atrial flutter	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Bradycardia	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Bundle branch block bilateral	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Cardiac dysfunction	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Cardiac failure congestive	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Cardiomegaly	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Cardiomyopathy	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Cardiovascular disorder	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Coronary artery disease	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Coronary artery stenosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Dilatation atrial	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Extrasystoles	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Hypertensive heart disease	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Left atrial dilatation	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Left ventricular dysfunction	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Left ventricular hypertrophy	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Mitral valve calcification	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Mitral valve incompetence	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.06% 4/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Palpitations	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Pulmonary valve incompetence	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Right atrial dilatation	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Sinus node dysfunction	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Tachycardia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Cardiac disorders Tricuspid valve incompetence	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Aneurysm	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Aortic arteriosclerosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Aortic dilatation	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Aortic disorder	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Aortic stenosis	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Deep vein thrombosis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Flushing	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Haematoma	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Hot flush	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Hypertension	0.55% 35/6352 • Number of events 35 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.42% 27/6366 • Number of events 27 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Hypertensive crisis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Hypotension	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Microangiopathy	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Peripheral coldness	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Peripheral vascular disorder	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Thrombosis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Vascular disorders Varicose vein	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Allergic cough	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Asthma	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.13% 8/6352 • Number of events 8 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Cough	0.66% 42/6352 • Number of events 42 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.72% 46/6366 • Number of events 47 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Dry throat	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.11% 7/6366 • Number of events 7 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Emphysema	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.46% 29/6352 • Number of events 31 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.47% 30/6366 • Number of events 32 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.74% 47/6352 • Number of events 47 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.64% 41/6366 • Number of events 42 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Pharyngeal paraesthesia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Productive cough	0.16% 10/6352 • Number of events 10 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.33% 21/6366 • Number of events 22 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.25% 16/6352 • Number of events 16 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.27% 17/6366 • Number of events 17 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Respiratory symptom	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.65% 41/6352 • Number of events 42 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.88% 56/6366 • Number of events 56 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Sneezing	0.49% 31/6352 • Number of events 33 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.39% 25/6366 • Number of events 27 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Tonsillar cyst	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Respiratory, thoracic and mediastinal disorders Wheezing	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Abdominal discomfort	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Abdominal distension	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Abdominal hernia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Abdominal pain	0.13% 8/6352 • Number of events 8 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.11% 7/6366 • Number of events 7 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Abdominal pain lower	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Abdominal pain upper	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.13% 8/6366 • Number of events 10 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Anal incontinence	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Aphthous ulcer	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Barrett's oesophagus	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Cheilitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Chronic gastritis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Constipation	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.09% 6/6366 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Diarrhoea	0.79% 50/6352 • Number of events 53 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.83% 53/6366 • Number of events 56 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Diverticulum	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Diverticulum intestinal	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Dry mouth	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Dyspepsia	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Dysphagia	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Enlarged uvula	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Faeces soft	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Flatulence	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Food poisoning	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Gastric ulcer	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Gastritis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Haemorrhoids	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Hiatus hernia	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Large intestine polyp	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Lip erythema	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Lip pruritus	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Lip swelling	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Lip ulceration	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Malocclusion	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Nausea	0.43% 27/6352 • Number of events 27 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.47% 30/6366 • Number of events 32 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Oesophageal food impaction	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Oesophageal motility disorder	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Oesophagitis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Oral pruritus	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Palatal oedema	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Salivary gland calculus	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Swollen tongue	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Tongue blistering	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Tooth impacted	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Tooth loss	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Toothache	0.13% 8/6352 • Number of events 8 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.09% 6/6366 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Gastrointestinal disorders Vomiting	0.20% 13/6352 • Number of events 13 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.20% 13/6366 • Number of events 14 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Biliary colic	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Cholangitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Cholangitis acute	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Cholecystitis acute	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Hepatobiliary disorders Steatohepatitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Acne	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Blood blister	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Dermatitis contact	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Diabetic foot	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Eczema	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Erythema	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Ingrown hair	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Nail bed disorder	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Night sweats	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Pruritus	0.14% 9/6352 • Number of events 10 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.13% 8/6366 • Number of events 9 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Pruritus generalised	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Rash	0.19% 12/6352 • Number of events 12 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.13% 8/6366 • Number of events 8 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Skin and subcutaneous tissue disorders Urticaria	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Arthralgia	0.39% 25/6352 • Number of events 25 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.47% 30/6366 • Number of events 30 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Arthritis	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Back pain	0.31% 20/6352 • Number of events 21 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.41% 26/6366 • Number of events 27 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Bursitis	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Coccydynia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Flank pain	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Groin pain	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Joint swelling	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Limb discomfort	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Muscle spasms	0.14% 9/6352 • Number of events 9 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Muscle tightness	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Muscular weakness	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.17% 11/6352 • Number of events 11 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.19% 12/6366 • Number of events 12 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Myalgia	0.50% 32/6352 • Number of events 34 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.55% 35/6366 • Number of events 35 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Myosclerosis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Neck mass	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Neck pain	0.16% 10/6352 • Number of events 11 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.16% 10/6366 • Number of events 10 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Nuchal rigidity	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.11% 7/6352 • Number of events 7 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.19% 12/6366 • Number of events 12 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Osteopenia	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Osteoporosis	0.09% 6/6352 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.06% 4/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Osteosclerosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	0.22% 14/6352 • Number of events 14 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.17% 11/6366 • Number of events 11 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Spondylitis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Synovial cyst	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Tendonitis	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Acute kidney injury	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Bladder discomfort	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Calculus urinary	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Chronic kidney disease	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.06% 4/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Dysuria	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Hypertensive nephropathy	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Hypertonic bladder	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Lower urinary tract symptoms	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Micturition urgency	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Nephrolithiasis	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Nephrotic syndrome	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Pollakiuria	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Renal cyst	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Renal disorder	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Urinary incontinence	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.11% 7/6366 • Number of events 7 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Reproductive system and breast disorders Erectile dysfunction	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders General physical health deterioration	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Hypothermia	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Induration	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Inflammation	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Influenza like illness	0.13% 8/6352 • Number of events 8 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.17% 11/6366 • Number of events 11 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Injected limb mobility decreased	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Injection site bruising	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.06% 4/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Injection site erythema	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Injection site haematoma	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Injection site induration	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Injection site pain	0.19% 12/6352 • Number of events 12 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.11% 7/6366 • Number of events 7 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Injection site pruritus	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.06% 4/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Injection site reaction	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Injection site swelling	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Injection site warmth	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Malaise	0.17% 11/6352 • Number of events 11 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.09% 6/6366 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Mass	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Oedema peripheral	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Pain	0.06% 4/6352 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Peripheral swelling	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Pyrexia	0.14% 9/6352 • Number of events 9 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.24% 15/6366 • Number of events 16 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Swelling	0.08% 5/6352 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.09% 6/6366 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Tenderness	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Vaccination site haematoma	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Vaccination site hypoaesthesia	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Vaccination site induration	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Vaccination site pain	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
General disorders Vaccination site pruritus	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Investigations Blood cholesterol increased	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Investigations Blood pressure increased	0.20% 13/6352 • Number of events 13 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.14% 9/6366 • Number of events 9 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Investigations Blood thyroid stimulating hormone increased	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Investigations Body temperature increased	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Investigations Cardiac imaging procedure abnormal	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Investigations Hepatic enzyme increased	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Investigations Thyroid hormones decreased	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Anaemia postoperative	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Animal bite	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Arthropod bite	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.06% 4/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Arthropod sting	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Back injury	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Chest injury	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Contusion	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Eye injury	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Face injury	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Facial bones fracture	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Fall	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.11% 7/6366 • Number of events 7 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Head injury	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Joint injury	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Laceration	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.06% 4/6366 • Number of events 4 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Ligament sprain	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Limb injury	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Meniscus injury	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Muscle contusion	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Muscle rupture	0.03% 2/6352 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Muscle strain	0.08% 5/6352 • Number of events 5 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Post-traumatic pain	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Procedural pain	0.05% 3/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.08% 5/6366 • Number of events 6 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Rib fracture	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Scratch	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.05% 3/6366 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Spinal compression fracture	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.03% 2/6366 • Number of events 2 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Sunburn	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Synovial rupture	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Tendon rupture	0.03% 2/6352 • Number of events 3 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Tongue injury	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Wound	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Wound complication	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/6352 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.02% 1/6366 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.
Injury, poisoning and procedural complications Bone contusion	0.02% 1/6352 • Number of events 1 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.	0.00% 0/6366 • Day 0 (post-vaccination) up to ~9 months SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Additional Information

Medical Director

Medicago

Phone: +1 418-658-9393

Email: clinicaltrialinquiries@medicago.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Investigator understands that the information in the protocol is confidential and should not be disclosed, other than to those directly involved in the execution or the ethical review of the study, without prior written authorization from the Sponsor. It is, however, permissible to discuss information contained in the protocol with a participant in order to obtain consent once Institutional Review Board (IRB) approval is obtained.
• Publication restrictions are in place

Restriction type: OTHER