Trial Outcomes & Findings for Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects (NCT NCT00551031)

Last Updated: 2016-05-16

Results Overview

Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

2098 participants

Primary outcome timeframe

Day 0 and Day 28 post vaccination

Results posted on

2016-05-16

Participant Flow

Participants were enrolled from 24 October to 31 October 2007 in 31 medical centers in the US.

A total of 2095 of the 2098 enrolled participants who met the inclusion and exclusion criteria were vaccinated.

Participant milestones

Participant milestones
Measure	Influenza Virus Vaccine Formulation 1 Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Influenza Virus Vaccine Formulation 2 Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Fluzone® Elderly Group Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)	Fluzone® High Dose Group Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)	Fluzone® Adults Group Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Overall Study STARTED	637	636	319	320	186
Overall Study COMPLETED	635	625	317	317	185
Overall Study NOT COMPLETED	2	11	2	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Influenza Virus Vaccine Formulation 1 Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Influenza Virus Vaccine Formulation 2 Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Fluzone® Elderly Group Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)	Fluzone® High Dose Group Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)	Fluzone® Adults Group Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Overall Study Adverse Event	0	1	0	0	0
Overall Study Protocol Violation	1	1	0	0	0
Overall Study Lost to Follow-up	0	1	0	1	1
Overall Study Withdrawal by Subject	0	4	1	2	0
Overall Study Serious Adverse Event	0	2	1	0	0
Overall Study Did not receive vaccine	1	2	0	0	0

Baseline Characteristics

Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Influenza Virus Vaccine Formulation 1 n=635 Participants Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Influenza Virus Vaccine Formulation 2 n=635 Participants Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Fluzone® Elderly Group n=319 Participants Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)	Fluzone® High Dose Group n=320 Participants Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)	Fluzone® Adults Group n=186 Participants Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)	Total n=2095 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=10 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	186 Participants n=21 Participants	186 Participants n=10 Participants
Age, Categorical >=65 years	635 Participants n=5 Participants	635 Participants n=7 Participants	319 Participants n=5 Participants	320 Participants n=4 Participants	0 Participants n=21 Participants	1909 Participants n=10 Participants
Age, Continuous	73.1 Years STANDARD_DEVIATION 6.03 • n=5 Participants	72.9 Years STANDARD_DEVIATION 5.86 • n=7 Participants	73.4 Years STANDARD_DEVIATION 5.91 • n=5 Participants	73.0 Years STANDARD_DEVIATION 6.00 • n=4 Participants	32.2 Years STANDARD_DEVIATION 8.49 • n=21 Participants	64.8 Years STANDARD_DEVIATION 6.458 • n=10 Participants
Sex: Female, Male Female	363 Participants n=5 Participants	347 Participants n=7 Participants	176 Participants n=5 Participants	183 Participants n=4 Participants	121 Participants n=21 Participants	1190 Participants n=10 Participants
Sex: Female, Male Male	272 Participants n=5 Participants	288 Participants n=7 Participants	143 Participants n=5 Participants	137 Participants n=4 Participants	65 Participants n=21 Participants	905 Participants n=10 Participants
Region of Enrollment United States	635 Participants n=5 Participants	635 Participants n=7 Participants	319 Participants n=5 Participants	320 Participants n=4 Participants	186 Participants n=21 Participants	2095 Participants n=10 Participants

PRIMARY outcome

Timeframe: Day 0 and Day 28 post vaccination

Population: Serum antibody titers GMTs were assessed in the per-protocol population.

Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.

Outcome measures

Outcome measures
Measure	Influenza Virus Vaccine Formulation 1 n=607 Participants Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Influenza Virus Vaccine Formulation 2 n=608 Participants Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Fluzone® Elderly Group n=304 Participants Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)	Fluzone® High Dose Group n=309 Participants Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)	Fluzone® Adults Group n=179 Participants Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. A/H1N1 Pre Dose (N=604, 607, 304, 309, 179)	18.3 Titers Interval 16.9 to 19.8	18.6 Titers Interval 17.1 to 20.2	17.8 Titers Interval 15.7 to 20.0	17.3 Titers Interval 15.3 to 19.5	41.4 Titers Interval 32.6 to 52.7
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. A/H1N1 Post Dose (N=605, 607, 304, 309, 179)	165.4 Titers Interval 149.2 to 183.4	174.1 Titers Interval 157.5 to 192.4	107.6 Titers Interval 93.2 to 124.3	236.1 Titers Interval 207.3 to 268.9	345.8 Titers Interval 294.1 to 406.6
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. A/H3N2 Pre Dose (N=606, 608, 304, 309, 179)	103.8 Titers Interval 93.1 to 115.9	104.7 Titers Interval 93.9 to 116.7	95.1 Titers Interval 82.1 to 110.3	99.3 Titers Interval 84.6 to 116.7	73.0 Titers Interval 58.7 to 90.8
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. A/H3N2 Post Dose (N=605, 608, 304, 309, 179)	348.3 Titers Interval 320.2 to 378.9	378.4 Titers Interval 346.9 to 412.7	276.9 Titers Interval 245.8 to 311.8	508.0 Titers Interval 452.6 to 570.1	398.3 Titers Interval 343.4 to 461.9
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. B Pre Dose (N=607, 608, 304, 309, 179)	24.7 Titers Interval 22.9 to 26.6	25.1 Titers Interval 23.3 to 27.1	24.7 Titers Interval 22.2 to 27.4	24.1 Titers Interval 21.7 to 26.8	15.5 Titers Interval 13.4 to 17.9
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. B Post Dose (N=607, 608, 304, 309, 179)	45.3 Titers Interval 42.3 to 48.4	47.5 Titers Interval 44.3 to 50.9	43.4 Titers Interval 39.2 to 48.0	59.9 Titers Interval 54.5 to 65.9	71.2 Titers Interval 61.7 to 82.3

PRIMARY outcome

Timeframe: Day 28 post-vaccination

Population: Serum antibody titers were assessed in the per protocol population.

Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer \< 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.

Outcome measures

Outcome measures
Measure	Influenza Virus Vaccine Formulation 1 n=607 Participants Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Influenza Virus Vaccine Formulation 2 n=608 Participants Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Fluzone® Elderly Group n=304 Participants Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)	Fluzone® High Dose Group n=309 Participants Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)	Fluzone® Adults Group n=179 Participants Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine A/H1N1 (N=604, 607, 304, 309, 179)	73 Percentage of Participants	74 Percentage of Participants	61 Percentage of Participants Interval 0.0 to 0.0	82 Percentage of Participants	62 Percentage of Participants
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine A/H3N2 (N=605, 608, 304, 309, 179)	42 Percentage of Participants	42 Percentage of Participants	37 Percentage of Participants Interval 0.0 to 0.0	56 Percentage of Participants	52 Percentage of Participants
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine B (N=607, 608, 304, 309, 179)	15 Percentage of Participants	15 Percentage of Participants	9 Percentage of Participants Interval 0.0 to 0.0	26 Percentage of Participants	44 Percentage of Participants

PRIMARY outcome

Timeframe: Day 0 and Day 28 post-vaccination

Population: Serum antibody titers were assessed in the per protocol population.

Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40

Outcome measures

Outcome measures
Measure	Influenza Virus Vaccine Formulation 1 n=607 Participants Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Influenza Virus Vaccine Formulation 2 n=608 Participants Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Fluzone® Elderly Group n=304 Participants Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)	Fluzone® High Dose Group n=309 Participants Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)	Fluzone® Adults Group n=179 Participants Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. A/H1N1 Pre Dose (N=604, 607, 304, 309, 179)	27 Percentage of Participants	25 Percentage of Participants	25 Percentage of Participants	23 Percentage of Participants	49 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. A/H1N1 Post Dose (N=605, 607, 304, 309, 179)	88 Percentage of Participants	90 Percentage of Participants	79 Percentage of Participants	94 Percentage of Participants	97 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. A/H3N2 Pre Dose (N=606, 608, 304, 309, 179)	78 Percentage of Participants	79 Percentage of Participants	80 Percentage of Participants	78 Percentage of Participants	72 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. A/H3N2 Post Dose (N=605, 608, 304, 309, 179)	98 Percentage of Participants	98 Percentage of Participants	97 Percentage of Participants	99 Percentage of Participants	99 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. B Pre Dose (N=607, 608, 304, 309, 179)	38 Percentage of Participants	37 Percentage of Participants	39 Percentage of Participants	37 Percentage of Participants	25 Percentage of Participants
Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. B Post Dose (N=607, 608, 304, 309, 179)	65 Percentage of Participants	67 Percentage of Participants	62 Percentage of Participants	77 Percentage of Participants	79 Percentage of Participants

SECONDARY outcome

Timeframe: Days 0 through 7 post-vaccination

Population: Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent to treat population.

Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Chills

Outcome measures

Outcome measures
Measure	Influenza Virus Vaccine Formulation 1 n=635 Participants Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Influenza Virus Vaccine Formulation 2 n=635 Participants Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Fluzone® Elderly Group n=319 Participants Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)	Fluzone® High Dose Group n=320 Participants Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)	Fluzone® Adults Group n=186 Participants Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Any Myalgia	86 Participants	106 Participants	46 Participants	79 Participants	68 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Any Injection Site Ecchymosis	38 Participants	41 Participants	19 Participants	17 Participants	14 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Grade 3 Ecchymosis (≥ 5 cm)	5 Participants	9 Participants	2 Participants	2 Participants	2 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Any Fever	14 Participants	18 Participants	5 Participants	17 Participants	10 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Any Injection Site Pain	174 Participants	187 Participants	57 Participants	117 Participants	106 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Grade 3 Pain (Prevents daily activities)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Any Injection Site Pruritus	204 Participants	214 Participants	27 Participants	17 Participants	24 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Grade 3 Pruritus (Prevents daily activities)	2 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Any Injection Site Erythema	426 Participants	434 Participants	48 Participants	55 Participants	29 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Grade 3 Erythema (≥ 5 cm)	109 Participants	108 Participants	5 Participants	12 Participants	5 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Any Injection Site Swelling	286 Participants	286 Participants	23 Participants Interval 0.0 to 0.0	45 Participants	14 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Grade 3 Swelling (≥ 5 cm)	50 Participants	49 Participants	6 Participants	16 Participants	1 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Any Injection Site Induration	310 Participants	311 Participants	33 Participants	45 Participants	20 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Grade 3 Induration (≥ 5 cm)	41 Participants	43 Participants	5 Participants	12 Participants	4 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Grade 3 Fever (> 102.2 ºF)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Any Headache	103 Participants	89 Participants	41 Participants	59 Participants	61 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Grade 3 Headache (Prevents daily activities)	2 Participants	6 Participants	1 Participants	2 Participants	2 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Any Malaise	76 Participants	98 Participants	42 Participants	50 Participants	45 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Grade 3 Malaise (Prevents daily activities)	5 Participants	3 Participants	0 Participants Interval 0.0 to 0.0	3 Participants	6 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Grade 3 Myalgia (Prevents daily activities)	2 Participants	2 Participants	1 Participants	3 Participants	1 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Any Chills	21 Participants	32 Participants	9 Participants	28 Participants	17 Participants
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. Grade 3 Chills (Prevents daily activities)	0 Participants	3 Participants	0 Participants	2 Participants	2 Participants

Adverse Events

Influenza Virus Vaccine Formulation 1

Serious events: 34 serious events

Other events: 426 other events

Deaths: 0 deaths

Influenza Virus Vaccine Formulation 2

Serious events: 38 serious events

Other events: 434 other events

Deaths: 0 deaths

Fluzone® Elderly Group

Serious events: 21 serious events

Other events: 57 other events

Deaths: 0 deaths

Fluzone® High Dose Group

Serious events: 16 serious events

Other events: 117 other events

Deaths: 0 deaths

Fluzone® Adults Group

Serious events: 7 serious events

Other events: 106 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Influenza Virus Vaccine Formulation 1 n=635 participants at risk Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Influenza Virus Vaccine Formulation 2 n=635 participants at risk Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Fluzone® Elderly Group n=319 participants at risk Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)	Fluzone® High Dose Group n=320 participants at risk Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)	Fluzone® Adults Group n=186 participants at risk Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
Infections and infestations Bronchitis	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Infections and infestations Cellulitis	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Infections and infestations Clostridial infection	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Infections and infestations Diverticulitis	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Infections and infestations Infection	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Infections and infestations Influenza	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/320 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Infections and infestations Otitis media	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/320 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Infections and infestations Pneumonia	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 2/635 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Cardiac disorders Acute myocardial infarction	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/320 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Cardiac disorders Angina pectoris	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Cardiac disorders Atrial fibrillation	0.31% 2/635 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.63% 2/319 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Cardiac disorders Cardiac arrest	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Cardiac disorders Cardiac failure	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Cardiac disorders Cardiac failure congestive	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/320 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Cardiac disorders Cardiovascular disorder	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Cardiac disorders Coronary artery disease	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Cardiac disorders Ventricular tachycardia	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.54% 1/186 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Ear and labyrinth disorders Meniere's disease	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Ear and labyrinth disorders Vertigo	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Gastrointestinal disorders Abdominal pain	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Gastrointestinal disorders Gastric ulcer	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Gastrointestinal disorders Gasgtrooesophageal reflux disease	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/320 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Gastrointestinal disorders Intestinal perforation	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Gastrointestinal disorders Large intestine perforation	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Gastrointestinal disorders Oesophagitis	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Gastrointestinal disorders Pancreatitis	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 2/635 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
General disorders Chest pain	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 2/635 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.63% 2/319 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.54% 1/186 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
General disorders Influenza like illness	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
General disorders Non cardiac chest pain	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.54% 1/186 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
General disorders Pain	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Hepatobiliary disorders Biliary colic	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Hepatobiliary disorders Gallbladder disorder	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Hepatobiliary disorders Hepatic failure	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Immune system disorders Drug hypersensitivity	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/320 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Immune system disorders Hypersensitivity	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Infections and infestations Viral infection	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Injury, poisoning and procedural complications Cardiac pacemaker malfunction	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Injury, poisoning and procedural complications Dislocation of joint prosthesis	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Injury, poisoning and procedural complications Head injury	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Injury, poisoning and procedural complications Joint injury	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Injury, poisoning and procedural complications Procedural pain	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Injury, poisoning and procedural complications Renal haematoma	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Injury, poisoning and procedural complications Stent graft material failure	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Injury, poisoning and procedural complications Subdural haematoma	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Injury, poisoning and procedural complications International normalised ratio increased	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Metabolism and nutrition disorders Dehydration	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/320 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.54% 1/186 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Metabolism and nutrition disorders Hypokalaemia	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Metabolism and nutrition disorders Hyponatraemia	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/320 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Musculoskeletal and connective tissue disorders Neck pain	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.31% 2/635 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/320 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 2/635 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/320 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/320 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Nervous system disorders Carotid artery stenosis	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Nervous system disorders Cerebrovascular accident	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.94% 3/319 • Number of events 3 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Nervous system disorders Intracranial aneurysm	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Nervous system disorders Lumbar radiculopathy	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Nervous system disorders Presyncope	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Nervous system disorders Syncope	0.31% 2/635 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.62% 2/320 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.54% 1/186 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Nervous system disorders Thrombotic stroke	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/320 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Nervous system disorders Transient ischaemic attack	0.31% 2/635 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 2/635 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Psychiatric disorders Depression	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Renal and urinary disorders Bladder prolapse	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Renal and urinary disorders Renal failure acute	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Renal and urinary disorders Urinary incontinence	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.54% 1/186 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 2/635 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Pharyngeal mass	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.31% 1/319 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.54% 1/186 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Vascular disorders Arteriosclerosis	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Vascular disorders Peripheral vascular disorder	0.00% 0/635 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.16% 1/635 • Number of events 1 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/319 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/320 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	0.00% 0/186 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.

Other adverse events

Other adverse events
Measure	Influenza Virus Vaccine Formulation 1 n=635 participants at risk Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Influenza Virus Vaccine Formulation 2 n=635 participants at risk Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System	Fluzone® Elderly Group n=319 participants at risk Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)	Fluzone® High Dose Group n=320 participants at risk Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)	Fluzone® Adults Group n=186 participants at risk Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
General disorders Injection site pain	27.4% 174/635 • Number of events 174 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	29.6% 187/632 • Number of events 187 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	17.9% 57/319 • Number of events 57 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	36.8% 117/318 • Number of events 117 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	57.3% 106/185 • Number of events 106 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
General disorders Injection site pruritus	32.1% 204/635 • Number of events 204 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	33.9% 214/632 • Number of events 214 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	8.5% 27/319 • Number of events 27 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	5.3% 17/318 • Number of events 17 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	13.0% 24/185 • Number of events 24 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
General disorders Injection site erythema	67.1% 426/635 • Number of events 426 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	68.7% 434/632 • Number of events 434 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	15.0% 48/319 • Number of events 48 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	17.2% 55/319 • Number of events 55 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	15.7% 29/185 • Number of events 29 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
General disorders Injection site swelling	45.0% 286/635 • Number of events 286 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	45.3% 286/631 • Number of events 286 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	7.2% 23/319 • Number of events 23 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	14.1% 45/319 • Number of events 45 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	7.6% 14/185 • Number of events 14 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
General disorders Injection site induration	48.8% 310/635 • Number of events 310 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	49.3% 311/631 • Number of events 311 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	10.3% 33/319 • Number of events 33 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	14.1% 45/319 • Number of events 45 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	10.8% 20/185 • Number of events 20 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
General disorders Injection site ecchymosis	6.0% 38/634 • Number of events 38 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	6.5% 41/631 • Number of events 41 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	6.0% 19/319 • Number of events 19 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	5.3% 17/319 • Number of events 17 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	7.6% 14/185 • Number of events 14 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
General disorders Fever	2.2% 14/630 • Number of events 14 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	2.9% 18/630 • Number of events 18 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	1.6% 5/319 • Number of events 5 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	5.3% 17/318 • Number of events 17 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	5.5% 10/182 • Number of events 10 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
General disorders Malaise	12.0% 76/634 • Number of events 76 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	15.5% 98/631 • Number of events 98 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	13.2% 42/319 • Number of events 42 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	15.7% 50/319 • Number of events 50 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	24.3% 45/185 • Number of events 45 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
General disorders Chills	3.3% 21/634 • Number of events 21 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	5.1% 32/632 • Number of events 32 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	2.8% 9/319 • Number of events 9 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	8.8% 28/319 • Number of events 28 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	9.2% 17/185 • Number of events 17 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Musculoskeletal and connective tissue disorders Myalgia	13.6% 86/634 • Number of events 86 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	16.8% 106/632 • Number of events 106 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	14.4% 46/319 • Number of events 46 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	24.8% 79/319 • Number of events 79 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	36.8% 68/185 • Number of events 68 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.
Nervous system disorders Headache	16.2% 103/634 • Number of events 103 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	14.1% 89/632 • Number of events 89 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	12.9% 41/319 • Number of events 41 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	18.5% 59/319 • Number of events 59 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.	33.0% 61/185 • Number of events 61 • Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
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