Trial Outcomes & Findings for ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2 (NCT NCT05329220)

Last Updated: 2025-02-24

Results Overview

The primary endpoint was SARS-CoV-2 index virus (Wuhan wild type isolate) neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part A Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part A Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

4205 participants

Primary outcome timeframe

2 weeks after the single trial vaccination occurring on Day 1

Results posted on

2025-02-24

Participant Flow

At least 500 subjects were to be enrolled into Part A of this trial, and approximately 3000 subjects were to be enrolled into Part B. Enrollment for Part A and Part B occurred simultaneously and enrollment was based on prior SARS-CoV-2 experience, with Cohort 1 including an authorized primary vaccination regimen; and Cohort 2 including an authorized primary vaccination regimen with a booster vaccination.

Three subjects were randomized but were withdrawn prior to receiving study product. One subject withdrew consent and two subjects were randomized in error and withdrawn due to not meeting inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	Part A Cohort 1 ABNCoV2 Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 1 Comirnaty Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1	Part A Cohort 2 ABNCoV2 Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 2 Comirnaty Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1	Part B Cohort 1 ABNCoV2 Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part B Cohort 2 ABNCoV2 Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
Active Trial Period STARTED	34	34	277	277	1438	2145
Active Trial Period COMPLETED	34	34	277	276	1390	2098
Active Trial Period NOT COMPLETED	0	0	0	1	48	47
Follow-up Period STARTED	34	34	277	277	1438	2144
Follow-up Period COMPLETED	34	33	272	273	1285	2009
Follow-up Period NOT COMPLETED	0	1	5	4	153	135

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A Cohort 1 Comirnaty Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1	Part A Cohort 2 ABNCoV2 Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 2 Comirnaty Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1	Part B Cohort 1 ABNCoV2 Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part B Cohort 2 ABNCoV2 Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
Active Trial Period Adverse Event	0	0	0	1	0
Active Trial Period Lost to Follow-up	0	0	0	32	28
Active Trial Period Physician Decision	0	0	0	2	0
Active Trial Period Protocol Violation	0	0	0	1	3
Active Trial Period Withdrawal by Subject	0	0	1	12	13
Active Trial Period SPONSOR GUIDANCE DUE TO SUBJECT'S CHANGE IN SCHEDULE WITH TRAVELING OUT OF THE COUNTRY	0	0	0	0	1
Active Trial Period THE PARTICIPANT HAD TO BE DROPPED FROM THE STUDY AS THEY WERE UNABLE TO CONTINUE.	0	0	0	0	1
Active Trial Period SUBJECT WAS OOW	0	0	0	0	1
Follow-up Period Adverse Event	0	0	0	2	1
Follow-up Period Death	0	1	1	0	1
Follow-up Period Lost to Follow-up	1	2	2	113	89
Follow-up Period Physician Decision	0	0	0	2	2
Follow-up Period Protocol Violation	0	0	0	0	1
Follow-up Period Withdrawal by Subject	0	1	1	34	35
Follow-up Period PATIENT WORKS IN AUSTRALIA SINCE JUNE2023	0	1	0	0	0
Follow-up Period SUBJECT WAS GOING OUT OF TOWN FOR AN EXTENDED PERIOD OF TIME	0	0	0	1	0
Follow-up Period SUBJECT NON-COMPLIANCE	0	0	0	1	0
Follow-up Period SUBJECT MOVED OUT OF TOWN	0	0	0	0	1
Follow-up Period EARLY TERMINATION	0	0	0	0	1
Follow-up Period SUBJECT HAD BUT DID NOT COMPLETE THEIR FINAL VISIT WITHIN 14 DAYS BEFORE THE V1 + 182 DAYS	0	0	0	0	2
Follow-up Period DROPPED	0	0	0	0	1
Follow-up Period DROPPED DUE TO BEING UNABLE TO CONTINUE IN THE TRIAL.	0	0	0	0	1

Baseline Characteristics

ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A Cohort 1 ABNCoV2 n=34 Participants Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 1 Comirnaty n=34 Participants Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1	Part A Cohort 2 ABNCoV2 n=277 Participants Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 2 Comirnaty n=277 Participants Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1	Part B Cohort 1 ABNCoV2 n=1438 Participants Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part B Cohort 2 ABNCoV2 n=2145 Participants Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1	Total n=4205 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	34 Participants n=7 Participants	247 Participants n=5 Participants	249 Participants n=4 Participants	1147 Participants n=21 Participants	1356 Participants n=8 Participants	3067 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	30 Participants n=5 Participants	28 Participants n=4 Participants	291 Participants n=21 Participants	789 Participants n=8 Participants	1138 Participants n=8 Participants
Age, Continuous	34.4 years STANDARD_DEVIATION 13.44 • n=5 Participants	32.2 years STANDARD_DEVIATION 11.67 • n=7 Participants	42.8 years STANDARD_DEVIATION 16.4 • n=5 Participants	41.8 years STANDARD_DEVIATION 15.91 • n=4 Participants	48.2 years STANDARD_DEVIATION 15.6 • n=21 Participants	54.5 years STANDARD_DEVIATION 15.73 • n=8 Participants	50.4 years STANDARD_DEVIATION 16.43 • n=8 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	12 Participants n=7 Participants	133 Participants n=5 Participants	135 Participants n=4 Participants	813 Participants n=21 Participants	1210 Participants n=8 Participants	2318 Participants n=8 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	22 Participants n=7 Participants	144 Participants n=5 Participants	142 Participants n=4 Participants	625 Participants n=21 Participants	935 Participants n=8 Participants	1887 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	00 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	623 Participants n=21 Participants	593 Participants n=8 Participants	1222 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	33 Participants n=7 Participants	274 Participants n=5 Participants	274 Participants n=4 Participants	795 Participants n=21 Participants	1523 Participants n=8 Participants	2933 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	20 Participants n=21 Participants	29 Participants n=8 Participants	50 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants	17 Participants n=8 Participants	23 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	27 Participants n=21 Participants	59 Participants n=8 Participants	89 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	439 Participants n=21 Participants	469 Participants n=8 Participants	909 Participants n=8 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	34 Participants n=7 Participants	272 Participants n=5 Participants	273 Participants n=4 Participants	911 Participants n=21 Participants	1521 Participants n=8 Participants	3044 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	14 Participants n=21 Participants	28 Participants n=8 Participants	43 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	41 Participants n=21 Participants	48 Participants n=8 Participants	94 Participants n=8 Participants
Region of Enrollment Belgium	24 participants n=5 Participants	26 participants n=7 Participants	161 participants n=5 Participants	167 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	378 participants n=8 Participants
Region of Enrollment United States	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1438 participants n=21 Participants	2145 participants n=8 Participants	3583 participants n=8 Participants
Region of Enrollment Denmark	10 participants n=5 Participants	8 participants n=7 Participants	116 participants n=5 Participants	110 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	244 participants n=8 Participants

PRIMARY outcome

Timeframe: 2 weeks after the single trial vaccination occurring on Day 1

Population: All subjects who are in the Safety Analysis Set, have at least a baseline and 1 post-vaccination neutralizing antibody result, and have neither intercurrent events indicative of SARSCoV2 infection nor received a booster for SARSCoV2 outside of the trial within 2 weeks of vaccination. Subjects with protocol deviations substantially affecting the immunogenicity outcomes were excluded from this analysis set.

Outcome measures

Outcome measures
Measure	Part A Cohort 1 ABNCoV2 n=34 Participants Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 1 Comirnaty n=33 Participants Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1	Part A Cohort 2 ABNCoV2 n=267 Participants Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 2 Comirnaty n=261 Participants Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1	Part B Cohort 1 ABNCoV2 Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part B Cohort 2 ABNCoV2 Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination	1018.1 titer Interval 621.1 to 1669.0	1060.6 titer Interval 708.2 to 1588.3	1259.0 titer Interval 1125.3 to 1408.4	1619.6 titer Interval 1485.9 to 1765.4	—	—

SECONDARY outcome

Timeframe: 2 weeks after the single trial vaccination occurring on Day 1

The secondary endpoint was SARS-CoV-2 variants of concern (Omicron Variant BA.4/BA.5 and XBB.1.5) pseudovirus or virus neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part A Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part A Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination.

Outcome measures

Outcome measures
Measure	Part A Cohort 1 ABNCoV2 n=265 Participants Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 1 Comirnaty n=260 Participants Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1	Part A Cohort 2 ABNCoV2 Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 2 Comirnaty Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1	Part B Cohort 1 ABNCoV2 Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part B Cohort 2 ABNCoV2 Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
Neutralizing Antibody Titers Against the SARS-CoV-2 Variants of Concern (Omicron Variants BA.4/BA.5 and XBB.1.5) at 2 Weeks After Trial Vaccination Omicron Variant BA.4/BA.5	17112.6 titer Interval 14775.8 to 19818.9	23506.3 titer Interval 20794.5 to 26571.7	—	—	—	—
Neutralizing Antibody Titers Against the SARS-CoV-2 Variants of Concern (Omicron Variants BA.4/BA.5 and XBB.1.5) at 2 Weeks After Trial Vaccination Omicron Variant XBB.1.5	54.7 titer Interval 48.9 to 61.3	81.3 titer Interval 73.1 to 90.4	—	—	—	—

SECONDARY outcome

Timeframe: 2 weeks after the single trial vaccination occurring on Day 1

Population: This secondary endpoint was defined in the protocol and originally intended to be performed on the Part B Cohorts. However, based on the assessment of Part A lower neutralizing antibody results versus the comparator it was decided not to analyze the Part B open-label samples. Due to there being no assays performed, there are no assay results to report.

The secondary endpoint was SARS-CoV-2 index virus (Wuhan wild type isolate) neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part B Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part B Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Active trial period is from vaccination until 28 to 35 days after vaccination. Entire trial period is from vaccination until 182 to 196 days after vaccination. Solicited events are reported if occurring within 8 days following vaccination.

Population: All subjects who received at least one vaccination with ABNCoV2 at any time during the trial.

The number and percent of subjects who report: * SAEs or AESIs assessed as related to trial vaccine during the entire trial period, which includes both the active trial phase and follow-up. * Grade 3 or higher AEs assessed as related to trial vaccine in the 8 day period starting with the day of vaccination. * SAEs, AESIs or MAAEs, regardless of relationship, during the active trial phase. * SAE, AESI or MAAEs, regardless of relationship, during the entire trial period. * Grade 3 or higher AEs assessed as related to trial vaccine during the active trial phase. * Solicited local AEs in the 8 day period starting with the day of vaccination. * Solicited general AEs in the 8 day period starting with the day of vaccination. Solicited event grading based on FDA 2007 Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials, where Grade 1 is Mild and Grade 4 is Life-Threatening and the worst outcome.

Outcome measures

Outcome measures
Measure	Part A Cohort 1 ABNCoV2 n=34 Participants Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 1 Comirnaty n=34 Participants Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1	Part A Cohort 2 ABNCoV2 n=277 Participants Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 2 Comirnaty n=277 Participants Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1	Part B Cohort 1 ABNCoV2 n=1438 Participants Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part B Cohort 2 ABNCoV2 n=2145 Participants Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
Safety and Tolerability of the ABNCoV2 Vaccine as Measured by the Frequency of Solicited and Unsolicited Adverse Events Occurring During or After the Trial Vaccination. Related SAEs during Entire Trial Period	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of the ABNCoV2 Vaccine as Measured by the Frequency of Solicited and Unsolicited Adverse Events Occurring During or After the Trial Vaccination. Related AESIs during Entire Trial Period	0 Participants	0 Participants	3 Participants	0 Participants	6 Participants	7 Participants
Safety and Tolerability of the ABNCoV2 Vaccine as Measured by the Frequency of Solicited and Unsolicited Adverse Events Occurring During or After the Trial Vaccination. Solicited Local AE within 8 Days of Vaccination	28 Participants	30 Participants	238 Participants	236 Participants	810 Participants	1269 Participants
Safety and Tolerability of the ABNCoV2 Vaccine as Measured by the Frequency of Solicited and Unsolicited Adverse Events Occurring During or After the Trial Vaccination. Related Grade 3 or Higher AEs within 8 Days of Vaccination	7 Participants	2 Participants	28 Participants	24 Participants	164 Participants	188 Participants
Safety and Tolerability of the ABNCoV2 Vaccine as Measured by the Frequency of Solicited and Unsolicited Adverse Events Occurring During or After the Trial Vaccination. SAE, AESI, or MAAE during Active Trial Period	1 Participants	3 Participants	42 Participants	30 Participants	96 Participants	204 Participants
Safety and Tolerability of the ABNCoV2 Vaccine as Measured by the Frequency of Solicited and Unsolicited Adverse Events Occurring During or After the Trial Vaccination. SAE, AESI, or MAAE during Entire Trial Period	6 Participants	6 Participants	85 Participants	78 Participants	192 Participants	442 Participants
Safety and Tolerability of the ABNCoV2 Vaccine as Measured by the Frequency of Solicited and Unsolicited Adverse Events Occurring During or After the Trial Vaccination. Related Grade 3 or Higher AEs during Active Trial Period	7 Participants	3 Participants	35 Participants	34 Participants	218 Participants	272 Participants
Safety and Tolerability of the ABNCoV2 Vaccine as Measured by the Frequency of Solicited and Unsolicited Adverse Events Occurring During or After the Trial Vaccination. Solicited Systemic AE within 8 Days of Vaccination	23 Participants	17 Participants	185 Participants	170 Participants	715 Participants	1139 Participants

Adverse Events

Part A Cohort 1 ABNCoV2

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Part A Cohort 1 Comirnaty

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part A Cohort 2 ABNCoV2

Serious events: 3 serious events

Other events: 40 other events

Deaths: 1 deaths

Part A Cohort 2 Comirnaty

Serious events: 7 serious events

Other events: 47 other events

Deaths: 1 deaths

Part B Cohort 1 ABNCoV2

Serious events: 23 serious events

Other events: 36 other events

Deaths: 0 deaths

Part B Cohort 2 ABNCoV2

Serious events: 49 serious events

Other events: 125 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Part A Cohort 1 ABNCoV2 n=34 participants at risk Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 1 Comirnaty n=34 participants at risk Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1	Part A Cohort 2 ABNCoV2 n=277 participants at risk Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 2 Comirnaty n=277 participants at risk Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1	Part B Cohort 1 ABNCoV2 n=1438 participants at risk Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part B Cohort 2 ABNCoV2 n=2145 participants at risk Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
Infections and infestations Sepsis	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.09% 2/2145 • Number of events 2 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Urinary tract infection	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.14% 3/2145 • Number of events 3 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Pneumonia	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.09% 2/2145 • Number of events 2 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Abdominal wall abscess	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Appendicitis	2.9% 1/34 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Arthritis bacterial	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Diverticulitis	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Helicobacter infection	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Large intestine infection	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Liver abscess	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Pelvic inflammatory disease	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Perirectal abscess	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Dengue fever	2.9% 1/34 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Intervertebral discitis	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.36% 1/277 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Nervous system disorders Cerebrovascular accident	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.14% 2/1438 • Number of events 2 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Nervous system disorders Syncope	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.36% 1/277 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.14% 2/1438 • Number of events 2 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Nervous system disorders Seizure	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Nervous system disorders Cerebral infarction	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Nervous system disorders Encephalopathy	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Nervous system disorders Ischaemic stroke	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Nervous system disorders Migraine	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Nervous system disorders Presyncope	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Nervous system disorders Transient ischaemic attack	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.36% 1/277 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Cardiac disorders Acute myocardial infarction	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.14% 2/1438 • Number of events 2 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Cardiac disorders Atrial fibrillation	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.14% 3/2145 • Number of events 3 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Cardiac disorders Coronary artery disease	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.09% 2/2145 • Number of events 2 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Cardiac disorders Acute coronary syndrome	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Cardiac disorders Bradycardia	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Cardiac disorders Cardiac failure congestive	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Cardiac disorders Myocarditis	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.36% 1/277 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Cardiac disorders Cardiac arrest	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.36% 1/277 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Cardiac disorders Myocardial ischaemia	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.36% 1/277 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Injury, poisoning and procedural complications Spinal cord injury cervical	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Injury, poisoning and procedural complications Wound necrosis	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.36% 1/277 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.09% 2/2145 • Number of events 2 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acoustic neuroma	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal squamous cell carcinoma	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell carcinoma	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.36% 1/277 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.14% 2/1438 • Number of events 2 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.14% 3/2145 • Number of events 3 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Renal and urinary disorders Acute kidney injury	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Renal and urinary disorders End stage renal disease	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Renal and urinary disorders Hydronephrosis	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Renal and urinary disorders Obstructive nephropathy	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Psychiatric disorders Anxiety	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Psychiatric disorders Bipolar disease	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Psychiatric disorders Delirium tremens	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Psychiatric disorders Depression	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Psychiatric disorders Major depression	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Psychiatric disorders Completed suicide	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.36% 1/277 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Psychiatric disorders Suicide attempt	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.36% 1/277 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Gastrointestinal disorders Abdominal pain	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Vascular disorders Arterial occlusive disease	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Vascular disorders Deep vein thrombosis	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Vascular disorders Hypertension	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Blood and lymphatic system disorders Anaemia	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Reproductive system and breast disorders Abnormal uterine bleeding	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Reproductive system and breast disorders Pelvic organ prolapse	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Ear and labyrinth disorders Vertigo positional	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
General disorders Systemic inflammatory response syndrome	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Hepatobiliary disorders Cholecystitis	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.07% 1/1438 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/2145 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Immune system disorders Drug hypersensitivity	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Investigations Astrovirus test positive	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/277 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/1438 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.05% 1/2145 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.

Other adverse events

Other adverse events
Measure	Part A Cohort 1 ABNCoV2 n=34 participants at risk Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 1 Comirnaty n=34 participants at risk Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1	Part A Cohort 2 ABNCoV2 n=277 participants at risk Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1	Part A Cohort 2 Comirnaty n=277 participants at risk Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1	Part B Cohort 1 ABNCoV2 n=1438 participants at risk Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1	Part B Cohort 2 ABNCoV2 n=2145 participants at risk Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
Infections and infestations COVID-19	2.9% 1/34 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	2.9% 1/34 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	6.1% 17/277 • Number of events 17 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	5.1% 14/277 • Number of events 14 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	2.5% 36/1438 • Number of events 36 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	5.8% 125/2145 • Number of events 125 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Nasopharyngitis	5.9% 2/34 • Number of events 2 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.00% 0/34 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	5.4% 15/277 • Number of events 15 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	7.6% 21/277 • Number of events 21 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.35% 5/1438 • Number of events 5 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.61% 13/2145 • Number of events 13 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Infections and infestations Pharyngitis	2.9% 1/34 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	5.9% 2/34 • Number of events 2 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.72% 2/277 • Number of events 2 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	1.1% 3/277 • Number of events 3 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.21% 3/1438 • Number of events 3 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.23% 5/2145 • Number of events 5 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Nervous system disorders Headache	8.8% 3/34 • Number of events 3 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	2.9% 1/34 • Number of events 1 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	4.0% 11/277 • Number of events 11 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	3.6% 10/277 • Number of events 11 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.76% 11/1438 • Number of events 11 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.	0.75% 16/2145 • Number of events 17 • Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.

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