Trial Outcomes & Findings for A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above (NCT NCT05059301)

NCT ID: NCT05059301

Last Updated: 2023-02-15

Results Overview

Enzyme-linked immunosorbent assay (ELISA) was used to assess the concentrations of IgG antibodies against RSV PreF3 in serum samples.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 770 participants
• Primary outcome timeframe: At 30 days post-vaccination (Day 31)
• Results posted on: 2023-02-15

Participant Flow

Out of 770 participants enrolled 757 received the study vaccine and were included in the Exposed Set.

Participant milestones

Measure	RSV OA_Lot 1 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 2 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 3 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).
Overall Study STARTED	251	253	253
Overall Study COMPLETED	249	248	248
Overall Study NOT COMPLETED	2	5	5

Reasons for withdrawal

Measure	RSV OA_Lot 1 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 2 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 3 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).
Overall Study Adverse Event	0	2	2
Overall Study Lost to Follow-up	2	3	3

Baseline Characteristics

A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above

Baseline characteristics by cohort

Measure	RSV OA_Lot 1 n=251 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 2 n=253 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 3 n=253 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).	Total n=757 Participants Total of all reporting groups
Age, Continuous	69.7 Years STANDARD_DEVIATION 6.6 • n=5 Participants	70.1 Years STANDARD_DEVIATION 6.6 • n=7 Participants	69.9 Years STANDARD_DEVIATION 6.6 • n=5 Participants	69.9 Years STANDARD_DEVIATION 6.6 • n=4 Participants
Sex: Female, Male Female	131 Participants n=5 Participants	131 Participants n=7 Participants	109 Participants n=5 Participants	371 Participants n=4 Participants
Sex: Female, Male Male	120 Participants n=5 Participants	122 Participants n=7 Participants	144 Participants n=5 Participants	386 Participants n=4 Participants
Race/Ethnicity, Customized ASIAN	6 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	26 Participants n=4 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	6 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized OTHER	8 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Race/Ethnicity, Customized WHITE	231 Participants n=5 Participants	231 Participants n=7 Participants	233 Participants n=5 Participants	695 Participants n=4 Participants

PRIMARY outcome

Timeframe: At 30 days post-vaccination (Day 31)

Population: The analysis was performed on the Per Protocol set (PPS) which consisted of all eligible subjects who received the study intervention as per protocol, had immunogenicity results pre- and post dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

Enzyme-linked immunosorbent assay (ELISA) was used to assess the concentrations of IgG antibodies against RSV PreF3 in serum samples.

Outcome measures

Measure	RSV OA_Lot 1 n=234 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 2 n=237 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 3 n=237 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).
RSVPreF3 Specific Immunoglobin (Ig)G Antibody Concentrations Expressed as Group Geometric Mean Concentration (GMC)	86039.9 ELISA Units/milliliter Interval 78541.5 to 94254.3	80518 ELISA Units/milliliter Interval 73150.0 to 88628.2	94260.9 ELISA Units/milliliter Interval 86042.2 to 103264.7

SECONDARY outcome

Timeframe: At 30 days post-vaccination (Day 31)

Population: The analysis was performed on the PPS which consisted of all eligible subjects who received the study intervention as per protocol, had immunogenicity results pre- and post dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

MGI was defined as the geometric mean of the within participant ratios of the post-vaccination RSV PreF3 IgG concentration over the pre-vaccination RSV PreF3 IgG concentration.

Outcome measures

Measure	RSV OA_Lot 1 n=234 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 2 n=237 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 3 n=237 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).
RSVPreF3 Specific IgG Antibody Concentrations Expressed as Mean Geometric Increase (MGI)	11.84 Ratio Interval 10.53 to 13.31	11.29 Ratio Interval 10.12 to 12.6	12.46 Ratio Interval 11.13 to 13.94

SECONDARY outcome

Timeframe: Within 4 days (the day of vaccination and 3 subsequent days) after study intervention administration

Population: The analysis was performed on participants of the Exposed Set (ES) who had their diary cards completed. The ES included all subjects who received the study intervention.

Solicited administration site adverse events (AEs) assessed were erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade.

Outcome measures

Measure	RSV OA_Lot 1 n=249 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 2 n=251 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 3 n=252 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).
Percentage of Participants Reporting Solicited Administration Site Events Erythema	12.4 Percentage of participants Interval 8.6 to 17.2	11.6 Percentage of participants Interval 7.9 to 16.2	13.5 Percentage of participants Interval 9.5 to 18.3
Percentage of Participants Reporting Solicited Administration Site Events Pain	58.2 Percentage of participants Interval 51.8 to 64.4	65.7 Percentage of participants Interval 59.5 to 71.6	62.7 Percentage of participants Interval 56.4 to 68.7
Percentage of Participants Reporting Solicited Administration Site Events Swelling	6.8 Percentage of participants Interval 4.0 to 10.7	7.6 Percentage of participants Interval 4.6 to 11.6	7.9 Percentage of participants Interval 4.9 to 12.0

SECONDARY outcome

Timeframe: Within 4 days (the day of vaccination and 3 subsequent days) after study intervention administration

Population: The analysis was performed on participants of the Exposed Set (ES) who had their diary cards completed. The ES included all subjects who received the study intervention.

Solicited systemic events assessed were arthralgia, fatigue, fever [defined as temperature equal to or above (>=) 38 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F)}, headache and myalgia. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.

Outcome measures

Measure	RSV OA_Lot 1 n=249 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 2 n=251 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 3 n=252 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).
Percentage of Participants Reporting Solicited Systemic Events Arthralgia	13.3 Percentage of participants Interval 9.3 to 18.1	13.9 Percentage of participants Interval 9.9 to 18.9	14.7 Percentage of participants Interval 10.6 to 19.7
Percentage of Participants Reporting Solicited Systemic Events Fatigue	28.1 Percentage of participants Interval 22.6 to 34.1	25.9 Percentage of participants Interval 20.6 to 31.8	27.8 Percentage of participants Interval 22.3 to 33.7
Percentage of Participants Reporting Solicited Systemic Events Fever	2 Percentage of participants Interval 0.7 to 4.6	1.6 Percentage of participants Interval 0.4 to 4.0	2.8 Percentage of participants Interval 1.1 to 5.6
Percentage of Participants Reporting Solicited Systemic Events Headache	25.7 Percentage of participants Interval 20.4 to 31.6	23.5 Percentage of participants Interval 18.4 to 29.2	22.2 Percentage of participants Interval 17.2 to 27.9
Percentage of Participants Reporting Solicited Systemic Events Myalgia	31.3 Percentage of participants Interval 25.6 to 37.5	34.3 Percentage of participants Interval 28.4 to 40.5	33.7 Percentage of participants Interval 27.9 to 39.9

SECONDARY outcome

Timeframe: Within 30 days (the day of vaccination and 29 subsequent days) after study intervention administration

Population: The analysis was performed on the ES, which included all subjects who received the study intervention.

An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Unsolicited AEs include serious, non-serious AEs and potential immune-mediated diseases (pIMDs).

Outcome measures

Measure	RSV OA_Lot 1 n=251 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 2 n=253 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 3 n=253 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).
Percentage of Participants Reporting at Least One Unsolicited Adverse Event	14.7 Percentage of participants Interval 10.6 to 19.7	14.6 Percentage of participants Interval 10.5 to 19.6	13.4 Percentage of participants Interval 9.5 to 18.3

SECONDARY outcome

Timeframe: From Day 1 up to study end (6 months after vaccination)

Population: The analysis was performed on the ES, which included all subjects who received the study intervention.

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.

Outcome measures

Measure	RSV OA_Lot 1 n=251 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 2 n=253 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 3 n=253 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).
Percentage of Participants Reporting at Least One Serious Adverse Event (SAE)	3.2 Percentage of Participants Interval 1.4 to 6.2	2.4 Percentage of Participants Interval 0.9 to 5.1	2.8 Percentage of Participants Interval 1.1 to 5.6

SECONDARY outcome

Timeframe: From Day 1 up to study end (6 months after vaccination)

Population: The analysis was performed on the ES, which included all subjects who received the study intervention.

pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Outcome measures

Measure	RSV OA_Lot 1 n=251 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 2 n=253 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 3 n=253 Participants Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).
Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD)	0.8 Percentage of participants Interval 0.1 to 2.8	0.4 Percentage of participants Interval 0.0 to 2.2	1.2 Percentage of participants Interval 0.2 to 3.4

Adverse Events

RSV OA_Lot 1

Serious events: 8 serious events

Other events: 181 other events

Deaths: 0 deaths

RSV OA_Lot 2

Serious events: 6 serious events

Other events: 192 other events

Deaths: 2 deaths

RSV OA_Lot 3

Serious events: 7 serious events

Other events: 195 other events

Deaths: 2 deaths

Serious adverse events

Measure	RSV OA_Lot 1 n=251 participants at risk Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 2 n=253 participants at risk Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 3 n=253 participants at risk Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).
Cardiac disorders Acute myocardial infarction	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Cardiac disorders Atrial fibrillation	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Cardiac disorders Cardiac arrest	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Cardiac disorders Myocardial infarction	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.79% 2/253 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the hypopharynx	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations COVID-19	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations Large intestine infection	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations Pneumonia	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations Sepsis	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Metabolism and nutrition disorders Gout	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Metabolism and nutrition disorders Malnutrition	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Nervous system disorders Ischaemic stroke	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Nervous system disorders Syncope	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
General disorders Sudden cardiac death	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Hepatobiliary disorders Cholecystitis	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Injury, poisoning and procedural complications Fall	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Renal and urinary disorders Urethral stenosis	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).

Other adverse events

Measure	RSV OA_Lot 1 n=251 participants at risk Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 2 n=253 participants at risk Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).	RSV OA_Lot 3 n=253 participants at risk Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).
General disorders Injection site pain	57.8% 145/251 • Number of events 145 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	65.2% 165/253 • Number of events 165 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	62.8% 159/253 • Number of events 160 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
General disorders Fatigue	27.9% 70/251 • Number of events 70 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	26.1% 66/253 • Number of events 66 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	28.5% 72/253 • Number of events 72 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
General disorders Injection site erythema	12.7% 32/251 • Number of events 32 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	11.5% 29/253 • Number of events 29 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	14.6% 37/253 • Number of events 37 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
General disorders Injection site swelling	6.8% 17/251 • Number of events 17 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	7.9% 20/253 • Number of events 20 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	7.9% 20/253 • Number of events 20 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
General disorders Pyrexia	3.2% 8/251 • Number of events 8 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	3.6% 9/253 • Number of events 9 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	3.6% 9/253 • Number of events 9 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
General disorders Chest discomfort	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
General disorders Chills	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.79% 2/253 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
General disorders Malaise	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
General disorders Chest pain	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
General disorders Influenza like illness	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
General disorders Pain	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
General disorders Peripheral swelling	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
General disorders Tenderness	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
General disorders Vaccination site pain	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Musculoskeletal and connective tissue disorders Myalgia	31.1% 78/251 • Number of events 78 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	34.4% 87/253 • Number of events 87 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	34.0% 86/253 • Number of events 86 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Musculoskeletal and connective tissue disorders Arthralgia	13.5% 34/251 • Number of events 34 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	14.2% 36/253 • Number of events 37 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	15.4% 39/253 • Number of events 39 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Musculoskeletal and connective tissue disorders Back pain	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Musculoskeletal and connective tissue disorders Bursitis	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.79% 2/253 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Musculoskeletal and connective tissue disorders Greater trochanteric pain syndrome	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Musculoskeletal and connective tissue disorders Muscle spasms	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Nervous system disorders Headache	25.9% 65/251 • Number of events 68 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	24.5% 62/253 • Number of events 64 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	22.5% 57/253 • Number of events 59 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Nervous system disorders Dizziness	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Nervous system disorders Migraine	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.79% 2/253 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Nervous system disorders Ophthalmic migraine	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Nervous system disorders Sciatica	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations Nasopharyngitis	1.2% 3/251 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.79% 2/253 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations Urinary tract infection	1.2% 3/251 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations COVID-19	0.80% 2/251 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations Upper respiratory tract infection	0.80% 2/251 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations Bronchitis	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations Gastroenteritis	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations Gastroenteritis caliciviral	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations Herpes zoster	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations Postoperative wound infection	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations Sinusitis	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Infections and infestations Tooth abscess	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.2% 3/251 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	1.2% 3/253 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Respiratory, thoracic and mediastinal disorders Asthma	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.79% 2/253 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.79% 2/253 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Gastrointestinal disorders Diarrhoea	0.80% 2/251 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Gastrointestinal disorders Nausea	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Gastrointestinal disorders Abdominal distension	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Gastrointestinal disorders Dyspepsia	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Gastrointestinal disorders Glossodynia	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Gastrointestinal disorders Oral mucosal blistering	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Gastrointestinal disorders Oral pain	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Gastrointestinal disorders Toothache	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Gastrointestinal disorders Vomiting	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Skin and subcutaneous tissue disorders Pruritus	0.80% 2/251 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.79% 2/253 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	1.2% 3/253 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.79% 2/253 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Skin and subcutaneous tissue disorders Rash	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Skin and subcutaneous tissue disorders Rosacea	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.79% 2/253 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Injury, poisoning and procedural complications Fall	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Injury, poisoning and procedural complications Fibula fracture	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Injury, poisoning and procedural complications Foreign body in respiratory tract	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Injury, poisoning and procedural complications Injury	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Injury, poisoning and procedural complications Muscle strain	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Injury, poisoning and procedural complications Skin laceration	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Cardiac disorders Atrial fibrillation	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Cardiac disorders Palpitations	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Ear and labyrinth disorders Vertigo	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Ear and labyrinth disorders Vertigo positional	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Eye disorders Age-related macular degeneration	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Eye disorders Ocular hyperaemia	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Psychiatric disorders Anxiety	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Renal and urinary disorders Chronic kidney disease	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Renal and urinary disorders Pollakiuria	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Investigations Computerised tomogram head abnormal	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/251 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.40% 1/253 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).
Vascular disorders Haematoma	0.40% 1/251 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).	0.00% 0/253 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after vaccination)).

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
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Restriction type: OTHER