Trial Outcomes & Findings for Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate (NCT NCT00321763)

Last Updated: 2018-06-08

Results Overview

Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

3124 participants

Primary outcome timeframe

At Days 0 and 21

Results posted on

2018-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	GSK1247446A Lot 1 Group Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Study STARTED	850	850	854	570
Overall Study COMPLETED	844	848	848	565
Overall Study NOT COMPLETED	6	2	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1247446A Lot 1 Group Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Study Adverse Event	1	1	0	1
Overall Study Withdrawal by Subject	2	0	1	0
Overall Study Lost to Follow-up	3	1	5	4

Baseline Characteristics

Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1247446A Lot 1 Group n=850 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group n=850 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group n=854 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group n=570 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.	Total n=3124 Participants Total of all reporting groups
Age, Continuous	68.4 Years STANDARD_DEVIATION 6.17 • n=5 Participants	68.8 Years STANDARD_DEVIATION 6.43 • n=7 Participants	68.7 Years STANDARD_DEVIATION 6.54 • n=5 Participants	68.3 Years STANDARD_DEVIATION 6.15 • n=4 Participants	68.6 Years STANDARD_DEVIATION 6.33 • n=21 Participants
Sex: Female, Male Female	475 Participants n=5 Participants	451 Participants n=7 Participants	479 Participants n=5 Participants	340 Participants n=4 Participants	1745 Participants n=21 Participants
Sex: Female, Male Male	375 Participants n=5 Participants	399 Participants n=7 Participants	375 Participants n=5 Participants	230 Participants n=4 Participants	1379 Participants n=21 Participants

PRIMARY outcome

Timeframe: At Days 0 and 21

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.

Outcome measures

Outcome measures
Measure	GSK1247446A Lot 1 Group n=494 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group n=494 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group n=499 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Pooled Group n=1487 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group n=106 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. A/New Caledonia, Day 0 [N=494;494;499;1487;106]	26.7 titers Interval 24.0 to 29.7	28.5 titers Interval 25.6 to 31.7	28.6 titers Interval 25.7 to 31.8	27.9 titers Interval 26.2 to 29.7	25.7 titers Interval 20.4 to 32.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. A/New Caledonia, Day 21 [N=492;488;492;1472;106]	121.4 titers Interval 108.9 to 135.3	119.1 titers Interval 107.5 to 132.0	133.8 titers Interval 120.4 to 148.8	124.6 titers Interval 117.3 to 132.4	130.6 titers Interval 100.3 to 170.1
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. A/New York, Day 0 [N=494;494;499;1487;106]	24.2 titers Interval 21.6 to 27.0	23.9 titers Interval 21.4 to 26.7	24.3 titers Interval 21.6 to 27.3	24.1 titers Interval 22.6 to 25.7	26.2 titers Interval 20.5 to 33.5
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. A/New York, Day 21 [N=492;488;492;1472;106]	189.3 titers Interval 168.3 to 213.0	192.3 titers Interval 171.7 to 215.5	187.3 titers Interval 167.5 to 209.5	189.6 titers Interval 177.5 to 202.6	110.9 titers Interval 85.0 to 144.7
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. B/Malaysia, Day 0 [N=494;494;499;1487;106]	29.6 titers Interval 26.4 to 33.1	29.7 titers Interval 26.7 to 33.1	31.8 titers Interval 28.3 to 35.6	30.3 titers Interval 28.4 to 32.4	27.7 titers Interval 21.5 to 35.8
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. B/Malaysia, Day 21 [N=492;488;492;1472;106]	243.0 titers Interval 218.4 to 270.2	229.9 titers Interval 208.3 to 253.7	238.7 titers Interval 216.5 to 263.3	237.1 titers Interval 223.7 to 251.4	167.0 titers Interval 131.6 to 211.8

PRIMARY outcome

Timeframe: At Day 21

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.

Outcome measures

Outcome measures
Measure	GSK1247446A Lot 1 Group n=491 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group n=487 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group n=492 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Pooled Group n=1470 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group n=106 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. A/New Caledonia, Day 21	214 subjects	205 subjects	233 subjects	652 subjects	47 subjects
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. A/New York, Day 21	308 subjects	309 subjects	313 subjects	930 subjects	49 subjects
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. B/Malaysia, Day 21	333 subjects	317 subjects	326 subjects	976 subjects	59 subjects

PRIMARY outcome

Timeframe: At Days 0 and 21

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.

Outcome measures

Outcome measures
Measure	GSK1247446A Lot 1 Group n=494 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group n=494 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group n=499 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Pooled Group n=1487 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group n=106 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. A/New Caledonia, Day 0 [N=494;494;499;1487;106]	221 subjects	220 subjects	229 subjects	670 subjects	46 subjects
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. A/New Caledonia, Day 21 [N=491;487;492;1470;106]	439 subjects	433 subjects	454 subjects	1326 subjects	94 subjects
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. A/New York, Day 0 [N=494;494;499;1487;106]	197 subjects	201 subjects	200 subjects	598 subjects	47 subjects
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. A/New York, Day 21 [N=491;487;492;1470;106]	451 subjects	447 subjects	454 subjects	1352 subjects	89 subjects
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. B/Malaysia, Day 0 [N=494;494;499;1487;106]	240 subjects	230 subjects	236 subjects	706 subjects	52 subjects
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. B/Malaysia, Day 21 [N=491;487;492;1470;106]	474 subjects	475 subjects	481 subjects	1430 subjects	97 subjects

PRIMARY outcome

Timeframe: At Day 21

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.

Outcome measures

Outcome measures
Measure	GSK1247446A Lot 1 Group n=491 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group n=487 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group n=492 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Pooled Group n=1470 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group n=106 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. A/New Caledonia, Day 21	4.6 fold increase Interval 4.0 to 5.2	4.2 fold increase Interval 3.7 to 4.7	4.7 fold increase Interval 4.1 to 5.4	4.5 fold increase Interval 4.2 to 4.8	5.1 fold increase Interval 3.7 to 7.1
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. A/New York, Day 21	7.9 fold increase Interval 6.9 to 9.0	7.9 fold increase Interval 7.0 to 9.1	7.7 fold increase Interval 6.8 to 8.8	7.8 fold increase Interval 7.3 to 8.5	4.2 fold increase Interval 3.2 to 5.5
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. B/Malaysia, Day 21	8.2 fold increase Interval 7.2 to 9.3	7.6 fold increase Interval 6.8 to 8.5	7.6 fold increase Interval 6.7 to 8.6	7.8 fold increase Interval 7.3 to 8.4	6.0 fold increase Interval 4.6 to 7.9

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with a documented dose and with symptom sheets completed .

Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related to study vaccination.

Outcome measures

Outcome measures
Measure	GSK1247446A Lot 1 Group n=847 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group n=850 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group n=851 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Pooled Group n=2548 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group n=568 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. Any Ecchymosis	22 subjects	34 subjects	30 subjects	86 subjects	17 subjects
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. Ecchymosis > 50 mm	1 subjects	2 subjects	3 subjects	6 subjects	0 subjects
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. Any Pain	470 subjects	449 subjects	456 subjects	1375 subjects	170 subjects
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. Grade 3 Pain	9 subjects	13 subjects	13 subjects	35 subjects	3 subjects
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. Any Redness	324 subjects	297 subjects	338 subjects	959 subjects	162 subjects
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. Redness > 50 mm	103 subjects	80 subjects	115 subjects	298 subjects	17 subjects
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. Any Swelling	241 subjects	208 subjects	238 subjects	687 subjects	87 subjects
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. Swelling > 50 mm	54 subjects	46 subjects	59 subjects	159 subjects	5 subjects

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with a documented dose and with symptom sheets completed .

Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.

Outcome measures

Outcome measures
Measure	GSK1247446A Lot 1 Group n=847 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group n=850 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group n=852 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Pooled Group n=2549 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group n=568 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Arthralgia	130 subjects	133 subjects	133 subjects	396 subjects	47 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Arthralgia	9 subjects	10 subjects	12 subjects	31 subjects	2 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Arthralgia	69 subjects	90 subjects	85 subjects	244 subjects	29 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue	251 subjects	210 subjects	233 subjects	694 subjects	101 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue	13 subjects	17 subjects	11 subjects	41 subjects	4 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue	156 subjects	143 subjects	144 subjects	443 subjects	53 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Fever ≥ 37.5°C	45 subjects	54 subjects	44 subjects	143 subjects	2 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Fever > 39.0°C	0 subjects	3 subjects	1 subjects	4 subjects	0 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fever	35 subjects	34 subjects	28 subjects	97 subjects	1 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Headache	182 subjects	167 subjects	182 subjects	531 subjects	77 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache	8 subjects	11 subjects	8 subjects	27 subjects	3 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Headache	100 subjects	109 subjects	111 subjects	320 subjects	38 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Muscle aches	254 subjects	234 subjects	245 subjects	733 subjects	79 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Muscle aches	8 subjects	13 subjects	17 subjects	38 subjects	0 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Muscle aches	159 subjects	160 subjects	156 subjects	475 subjects	46 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Shivering	92 subjects	93 subjects	90 subjects	275 subjects	28 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Shivering	8 subjects	11 subjects	9 subjects	28 subjects	0 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Shivering	51 subjects	62 subjects	45 subjects	158 subjects	13 subjects

PRIMARY outcome

Timeframe: From Day 0 to Day 180

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs.

Outcome measures

Outcome measures
Measure	GSK1247446A Lot 1 Group n=850 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group n=850 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group n=854 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Pooled Group n=2554 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group n=570 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Subjects With New Onset of Chronic Diseases (NOCDs).	3 subjects	3 subjects	2 subjects	8 subjects	1 subjects

PRIMARY outcome

Timeframe: From Day 0 to Day 180

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs.

Outcome measures

Outcome measures
Measure	GSK1247446A Lot 1 Group n=850 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group n=850 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group n=854 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Pooled Group n=2554 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group n=570 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Subjects With Medically Significant Conditions (MSCs).	70 subjects	69 subjects	72 subjects	211 subjects	52 subjects

PRIMARY outcome

Timeframe: During the 30-day (Days 0-29) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs.

Outcome measures

Outcome measures
Measure	GSK1247446A Lot 1 Group n=850 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group n=850 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group n=854 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Pooled Group n=2554 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group n=570 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Subjects with any AE(s)	133 subjects	150 subjects	162 subjects	445 subjects	109 subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Subjects with any Grade 3 AE(s)	11 subjects	14 subjects	15 subjects	40 subjects	10 subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Subjects with any related AE(s)	47 subjects	57 subjects	65 subjects	169 subjects	16 subjects

PRIMARY outcome

Timeframe: During the entire study period (Days 0-180)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK1247446A Lot 1 Group n=850 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group n=850 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group n=854 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Pooled Group n=2554 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group n=570 Participants Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Number of Subjects With Any and Related Serious Adverse Events (SAEs). Any SAE(s), Days 0-29 [N=850;850;854;2554;570]	4 subjects	4 subjects	3 subjects	11 subjects	4 subjects
Number of Subjects With Any and Related Serious Adverse Events (SAEs). REL SAE(s), Days 0-29 [N=850;850;854;2554;570]	0 subjects	0 subjects	0 subjects	0 subjects	0 subjects
Number of Subjects With Any and Related Serious Adverse Events (SAEs). Any SAE(s), Days 30-180 [N=844;848;848;2540;565]	26 subjects	20 subjects	20 subjects	66 subjects	17 subjects
Number of Subjects With Any and Related Serious Adverse Events (SAEs). REL SAE(s), Days 30-180 [N=844;848;848;2540;565]	0 subjects	1 subjects	0 subjects	1 subjects	0 subjects

Adverse Events

GSK1247446A Lot 1 Group

Serious events: 30 serious events

Other events: 653 other events

Deaths: 0 deaths

GSK1247446A Lot 2 Group

Serious events: 24 serious events

Other events: 636 other events

Deaths: 0 deaths

GSK1247446A Lot 3 Group

Serious events: 23 serious events

Other events: 634 other events

Deaths: 0 deaths

GSK1247446A Pooled Group

Serious events: 77 serious events

Other events: 1923 other events

Deaths: 0 deaths

Fluarix Group

Serious events: 21 serious events

Other events: 321 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK1247446A Lot 1 Group n=850 participants at risk Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group n=850 participants at risk Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group n=854 participants at risk Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Pooled Group n=2554 participants at risk Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group n=570 participants at risk Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Cardiac disorders Arrhythmia	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Infections and infestations Urinary tract infection	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.08% 2/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
General disorders Abdominal pain	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Cardiac disorders Cardiac valve disease	0.12% 1/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Injury, poisoning and procedural complications Foot fracture	0.12% 1/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Infections and infestations Pneumonia	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Eye disorders Retinal artery embolism	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Eye disorders Retinal detachment	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Cardiac disorders Angina pectoris	0.47% 4/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.16% 4/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Gastrointestinal disorders Ileus	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Cardiac disorders Myocardial infarction	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Nervous system disorders Syncope	0.24% 2/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.24% 2/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.20% 5/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
General disorders Chest pain	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.08% 2/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Nervous system disorders Cerebrovascular accident	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.08% 2/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.35% 2/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Hepatobiliary disorders Cholelithiasis	0.24% 2/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.08% 2/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Vascular disorders Circulatory collapse	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.08% 2/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Gastrointestinal disorders Constipation	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.24% 2/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.08% 2/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Cardiac disorders Coronary artery disease	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.24% 2/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.08% 2/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.24% 2/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.08% 2/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.08% 2/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Hepatobiliary disorders Bile duct stone	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Gastrointestinal disorders Colonic polyp	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Cardiac disorders Acute myocardial infarction	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Blood and lymphatic system disorders Anaemia	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Vascular disorders Aortic stenosis	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Cardiac disorders Cardiovascular disorder	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Nervous system disorders Cerebral infarction	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Infections and infestations Cholecystitis infective	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Psychiatric disorders Completed suicide	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Infections and infestations Diverticulitis	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Injury, poisoning and procedural complications Excoriation	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Musculoskeletal and connective tissue disorders Foot deformity	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Injury, poisoning and procedural complications Foreign body trauma	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Gastrointestinal disorders Gastritis	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
General disorders General physical health deterioration	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Endocrine disorders Hyperthyroidism	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Vascular disorders Iliac artery stenosis	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Musculoskeletal and connective tissue disorders Mixed connective tissue disease	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Renal and urinary disorders Nephrolithiasis	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Gastrointestinal disorders Pancreatitis	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Vascular disorders Peripheral vascular disorder	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma stage unspecified	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Musculoskeletal and connective tissue disorders Spinal disorder	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Psychiatric disorders Stress	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Psychiatric disorders Suicide attempt	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Cardiac disorders Tachyarrhythmia	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Cardiac disorders Tachycardia paroxysmal	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Nervous system disorders Trigeminal neuralgia	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Cardiac disorders Acute coronary syndrome	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Vascular disorders Aortic aneurysm	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Gastrointestinal disorders Gallstone ileus	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Vascular disorders Hypertension	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
General disorders Pyrexia	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Reproductive system and breast disorders Uterine polyp	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Cardiac disorders Cardiac failure	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
General disorders Oedema	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Hepatobiliary disorders Hepatorenal failure	0.12% 1/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Infections and infestations Diabetic gangrene	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.12% 1/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.04% 1/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
Nervous system disorders Thrombotic stroke	0.00% 0/844 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/848 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.00% 0/2540 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.18% 1/565 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.

Other adverse events

Other adverse events
Measure	GSK1247446A Lot 1 Group n=850 participants at risk Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 2 Group n=850 participants at risk Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Lot 3 Group n=854 participants at risk Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	GSK1247446A Pooled Group n=2554 participants at risk Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.	Fluarix Group n=570 participants at risk Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
General disorders Pain	55.3% 470/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	52.8% 449/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	53.4% 456/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	53.8% 1375/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	29.8% 170/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
General disorders Redness	38.1% 324/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	34.9% 297/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	39.6% 338/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	37.5% 959/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	28.4% 162/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
General disorders Swelling	28.4% 241/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	24.5% 208/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	27.9% 238/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	26.9% 687/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	15.3% 87/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
General disorders Arthralgia	15.3% 130/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	15.6% 133/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	15.6% 133/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	15.5% 396/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	8.2% 47/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
General disorders Fatigue	29.5% 251/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	24.7% 210/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	27.3% 233/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	27.2% 694/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	17.7% 101/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
General disorders Fever	5.3% 45/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	6.4% 54/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	5.2% 44/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	5.6% 143/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	0.35% 2/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
General disorders Headache	21.4% 182/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	19.6% 167/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	21.3% 182/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	20.8% 531/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	13.5% 77/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
General disorders Muscle aches	29.9% 254/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	27.5% 234/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	28.7% 245/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	28.7% 733/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	13.9% 79/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
General disorders Shivering	10.8% 92/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	10.9% 93/850 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	10.5% 90/854 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	10.8% 275/2554 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.	4.9% 28/570 • SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.

Additional Information

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Results disclosure agreements

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